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Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00739973
Recruitment Status : Completed
First Posted : August 22, 2008
Results First Posted : May 3, 2011
Last Update Posted : June 6, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Placebo
Drug: Aliskiren 150 mg tablet
Drug: Aliskiren 300 mg tablet
Drug: Amlodipine 5 mg capsule
Drug: Amlodipine 10 mg capsule
Drug: Aliskiren/amlodipine 150/5 mg tablet
Drug: Aliskiren/amlodipine 150/10 mg tablet
Drug: Aliskiren/amlodipine 300/5 mg tablet
Drug: Aliskiren/amlodipine 300/10 mg tablet
Enrollment 2694
Recruitment Details A total of 2694 patients enrolled in the single-blind, placebo run-in period (2 to 4 weeks) of the study. A total of 1688 patients were randomized into the double-blind treatment period (8 weeks). Three patients were mis-randomized, as they were discontinued from the single-blind period and were not treated in the double-blind period.
Pre-assignment Details  
Arm/Group Title Placebo Aliskiren 150 mg Aliskiren 300 mg Amlodipine 5 mg Amlodipine 10 mg Aliskiren/Amlodipine 150/5 mg Aliskiren/Amlodipine 150/10 mg Aliskiren/Amlodipine 300/5 mg Aliskiren/Amlodipine 300/10 mg Tablet
Hide Arm/Group Description Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. 150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. 300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Period Title: Single-blind Period (2 to 4 Weeks)
Started 2694 [1] 0 0 0 0 0 0 0 0
Completed 1685 0 0 0 0 0 0 0 0
Not Completed 1009 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             35             0             0             0             0             0             0             0             0
Abnormal laboratory value(s)             38             0             0             0             0             0             0             0             0
Abnormal test procedure result(s)             810             0             0             0             0             0             0             0             0
Patient withdrew consent             86             0             0             0             0             0             0             0             0
Lost to Follow-up             17             0             0             0             0             0             0             0             0
Administrative problems             12             0             0             0             0             0             0             0             0
Protocol deviation             11             0             0             0             0             0             0             0             0
[1]
In this period, participants were enrolled to only Placebo arm.
Period Title: Double-blind:Randomized Period (8 Weeks)
Started 198 195 [1] 203 185 181 181 183 [2] 178 184
Completed 168 175 184 173 162 169 170 168 170
Not Completed 30 20 19 12 19 12 13 10 14
Reason Not Completed
Adverse Event             3             3             1             2             7             3             4             1             4
Abnormal laboratory values             0             0             0             0             1             0             0             1             0
Abnormal test procedure results             1             1             0             0             0             0             0             0             0
Unsatisfactory therapeutic effect             17             8             8             4             2             2             1             1             2
Patient no longer needs study drug             0             0             1             0             0             0             0             0             0
Patient withdrew consent             4             2             4             3             4             4             3             2             4
Lost to Follow-up             0             2             4             1             2             2             0             3             1
Administrative problems             0             0             0             0             0             0             1             0             0
Protocol deviation             5             3             1             2             3             1             2             2             3
Discont. single-blind, Mis- randomized             0             1             0             0             0             0             2             0             0
[1]
One pt. was mis-randomized, so discontinued from single-blind and was untreated in the double-blind.
[2]
2 pts. were mis-randomized, so discontinued from single-blind and were untreated in double-blind.
Arm/Group Title Placebo Aliskiren 150 mg Aliskiren 300 mg Amlodipine 5 mg Amlodipine 10 mg Aliskiren/Amlodipine 150/5 mg Aliskiren/Amlodipine 150/10 mg Aliskiren/Amlodipine 300/5 mg Aliskiren/Amlodipine 300/10 mg Tablet Total
Hide Arm/Group Description Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. 150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. 300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Total of all reporting groups
Overall Number of Baseline Participants 198 195 203 185 181 181 183 178 184 1688
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 198 participants 195 participants 203 participants 185 participants 181 participants 181 participants 183 participants 178 participants 184 participants 1688 participants
53.7  (10.32) 54.3  (11.07) 54.0  (9.99) 54.2  (11.61) 55.0  (10.34) 53.9  (10.82) 53.0  (10.59) 54.8  (10.29) 54.4  (10.86) 54.1  (10.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 195 participants 203 participants 185 participants 181 participants 181 participants 183 participants 178 participants 184 participants 1688 participants
Female
108
  54.5%
76
  39.0%
108
  53.2%
86
  46.5%
94
  51.9%
84
  46.4%
96
  52.5%
100
  56.2%
78
  42.4%
830
  49.2%
Male
90
  45.5%
119
  61.0%
95
  46.8%
99
  53.5%
87
  48.1%
97
  53.6%
87
  47.5%
78
  43.8%
106
  57.6%
858
  50.8%
1.Primary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Aliskiren 150 mg Aliskiren/Amlodipine 150/5 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 193 179
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-7.99  (0.63) -13.98  (0.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aliskiren 150 mg, Aliskiren/Amlodipine 150/5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -6.00
Confidence Interval (2-Sided) 95%
-7.77 to -4.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.90
Estimation Comments [Not Specified]
2.Primary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Amlodipine 5 mg Aliskiren/Amlodipine 150/5 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 184 179
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-11.0  (0.65) -13.98  (0.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 5 mg, Aliskiren/Amlodipine 150/5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -2.98
Confidence Interval (2-Sided) 95%
-4.77 to -1.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.91
Estimation Comments [Not Specified]
3.Primary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Placebo Aliskiren/Amlodipine 150/5 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 198 179
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-5.35  (0.62) -13.98  (0.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Aliskiren/Amlodipine 150/5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -8.63
Confidence Interval (2-Sided) 95%
-10.39 to -6.87
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.90
Estimation Comments [Not Specified]
4.Primary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Aliskiren 150 mg Aliskiren/Amlodipine 150/10 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 193 179
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-7.99  (0.63) -16.16  (0.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aliskiren 150 mg, Aliskiren/Amlodipine 150/10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -8.17
Confidence Interval (2-Sided) 95%
-9.94 to -6.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.90
Estimation Comments [Not Specified]
5.Primary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Amlodipine 10 mg Aliskiren/Amlodipine 150/10 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 179 179
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-13.82  (0.66) -16.16  (0.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 10 mg, Aliskiren/Amlodipine 150/10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Sqaure Mean Difference
Estimated Value -2.33
Confidence Interval (2-Sided) 95%
-4.14 to -0.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.92
Estimation Comments [Not Specified]
6.Primary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Placebo Aliskiren/Amlodipine 150/10 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 198 179
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-5.35  (0.62) -16.16  (0.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Aliskiren/Amlodipine 150/10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -10.81
Confidence Interval (2-Sided) 95%
-12.57 to -9.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.90
Estimation Comments [Not Specified]
7.Primary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Aliskiren 300 mg Aliskiren/Amlodipine 300/5 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 201 175
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-10.19  (0.62) -14.99  (0.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aliskiren 300 mg, Aliskiren/Amlodipine 300/5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -4.79
Confidence Interval (2-Sided) 95%
-6.56 to -3.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.90
Estimation Comments [Not Specified]
8.Primary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Amlodipine 5 mg Aliskiren/Amlodipine 300/5 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 184 175
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-11.0  (0.65) -14.99  (0.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 5 mg, Aliskiren/Amlodipine 300/5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -3.98
Confidence Interval (2-Sided) 95%
-5.78 to -2.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.92
Estimation Comments [Not Specified]
9.Primary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Placebo Aliskiren/Amlodipine 300/5 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 198 175
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-5.35  (0.62) -14.99  (0.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Aliskiren/Amlodipine 300/5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -9.64
Confidence Interval (2-Sided) 95%
-11.41 to -7.87
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.90
Estimation Comments [Not Specified]
10.Primary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Aliskiren 300 mg Aliskiren/Amlodipine 300/10 mg Tablet
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 201 183
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-10.19  (0.62) -16.45  (0.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aliskiren 300 mg, Aliskiren/Amlodipine 300/10 mg Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -6.26
Confidence Interval (2-Sided) 95%
-8.00 to -4.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.89
Estimation Comments [Not Specified]
11.Primary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Amlodipine 10 mg Aliskiren/Amlodipine 300/10 mg Tablet
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 179 183
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-13.82  (0.66) -16.45  (0.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 10 mg, Aliskiren/Amlodipine 300/10 mg Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -2.63
Confidence Interval (2-Sided) 95%
-4.42 to -0.83
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.92
Estimation Comments [Not Specified]
12.Primary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Placebo Aliskiren/Amlodipine 300/10 mg Tablet
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 198 183
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-5.35  (0.62) -16.45  (0.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Aliskiren/Amlodipine 300/10 mg Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -11.10
Confidence Interval (2-Sided) 95%
-12.85 to -9.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.89
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Aliskiren 150 mg Aliskiren/Amlodipine 150/5 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 193 179
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-10.67  (1.01) -20.64  (1.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aliskiren 150 mg, Aliskiren/Amlodipine 150/5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -9.97
Confidence Interval (2-Sided) 95%
-12.81 to -7.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.45
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Amlodipine 5 mg Aliskiren/Amlodipine 150/5 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 184 179
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-15.82  (1.04) -20.64  (1.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 5 mg, Aliskiren/Amlodipine 150/5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square mean Difference
Estimated Value -4.82
Confidence Interval (2-Sided) 95%
-7.70 to -1.94
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.47
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Placebo Aliskiren/Amlodipine 150/5 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 198 179
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-6.79  (1.00) -20.64  (1.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Aliskiren/Amlodipine 150/5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -13.85
Confidence Interval (2-Sided) 95%
-16.68 to -11.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.44
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Aliskiren 150 mg Aliskiren/Amlodipine 150/10 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 193 179
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-10.67  (1.01) -23.87  (1.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aliskiren 150 mg, Aliskiren/Amlodipine 150/10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -13.20
Confidence Interval (2-Sided) 95%
-16.04 to -10.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.45
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized patients who received the study medication.
Arm/Group Title Amlodipine 10 mg Aliskiren/Amlodipine 150/10 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 179 179
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-21.04  (1.05) -23.87  (1.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 10 mg, Aliskiren/Amlodipine 150/10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -2.83
Confidence Interval (2-Sided) 95%
-5.73 to -0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.48
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Placebo Aliskiren/Amlodipine 150/10 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 198 179
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-6.79  (1.00) -23.87  (1.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Aliskiren/Amlodipine 150/10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -17.08
Confidence Interval 95%
-19.91 to -14.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.44
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Aliskiren 300 mg Aliskiren/Amlodipine 300/5 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 201 175
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-15.37  (0.99) -21.82  (1.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aliskiren 300 mg, Aliskiren/Amlodipine 300/5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -6.45
Confidence Interval (2-Sided) 95%
-9.29 to -3.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.45
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Amlodipine 5 mg Aliskiren/Amlodipine 300/5 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 184 175
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-15.82  (1.04) -21.82  (1.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 5 mg, Aliskiren/Amlodipine 300/5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region asntwo factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -6.00
Confidence Interval (2-Sided) 95%
-8.90 to -3.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.48
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Placebo Aliskiren/Amlodipine 300/5 mg
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 198 175
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-6.79  (1.00) -21.82  (1.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Aliskiren/Amlodipine 300/5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -15.03
Confidence Interval (2-Sided) 95%
-17.88 to -12.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.45
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Aliskiren 300 mg Aliskiren/Amlodipine 300/10 mg Tablet
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 201 183
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-15.37  (0.99) -23.19  (1.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aliskiren 300 mg, Aliskiren/Amlodipine 300/10 mg Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -7.82
Confidence Interval (2-Sided) 95%
-10.63 to -5.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.43
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Amlodipine 10 mg Aliskiren/Amlodipine 300/10 mg Tablet
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 179 183
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-21.04  (1.05) -23.19  (1.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 10 mg, Aliskiren/Amlodipine 300/10 mg Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -2.16
Confidence Interval (2-Sided) 95%
-5.04 to 0.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.47
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.
Arm/Group Title Placebo Aliskiren/Amlodipine 300/10 mg Tablet
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 198 183
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-6.79  (1.00) -23.19  (1.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Aliskiren/Amlodipine 300/10 mg Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -16.40
Confidence Interval (2-Sided) 95%
-19.21 to -13.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.43
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study
Hide Description Blood pressure control defined as msSBP < 140 mm Hg and msDBP < 90 mm Hg. The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame End of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.
Arm/Group Title Placebo Aliskiren 150 mg Aliskiren 300 mg Amlodipine 5 mg Amlodipine 10 mg Aliskiren/Amlodipine 150/5 mg Aliskiren/Amlodipine 150/10 mg Aliskiren/Amlodipine 300/5 mg Aliskiren/Amlodipine 300/10 mg Tablet
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 198 193 201 184 179 179 179 175 183
Measure Type: Number
Unit of Measure: Percentage of Participants
19.2 26.9 36.3 35.9 50.3 49.2 65.4 56.5 68.3
26.Secondary Outcome
Title Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response
Hide Description Blood pressure response in msDBP is defined as a mean sitting diastolic blood pressure < 90 mmHg or a >=10 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame End of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.
Arm/Group Title Placebo Aliskiren 150 mg Aliskiren 300 mg Amlodipine 5 mg Amlodipine 10 mg Aliskiren/Amlodipine 150/5 mg Aliskiren/Amlodipine 150/10 mg Aliskiren/Amlodipine 300/5 mg Aliskiren/Amlodipine 300/10 mg Tablet
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 198 193 201 184 179 179 179 175 183
Measure Type: Number
Unit of Measure: Percentage of Participants
34.3 50.3 54.2 62.0 74.3 73.2 83.8 73.7 84.7
27.Secondary Outcome
Title Percentage of Patients Achieving a Successful Systolic Blood Pressure Response
Hide Description Blood pressure response in msSBP is defined as a mean sitting systolic blood pressure < 140 mmHg or a >= 20 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Time Frame End of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.
Arm/Group Title Placebo Aliskiren 150 mg Aliskiren 300 mg Amlodipine 5 mg Amlodipine 10 mg Aliskiren/Amlodipine 150/5 mg Aliskiren/Amlodipine 150/10 mg Aliskiren/Amlodipine 300/5 mg Aliskiren/Amlodipine 300/10 mg Tablet
Hide Arm/Group Description:
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
Overall Number of Participants Analyzed 198 193 201 184 179 179 179 175 183
Measure Type: Number
Unit of Measure: Percentage of Participants
32.3 41.5 53.2 54.9 72.1 67.6 77.1 69.7 80.3
Time Frame Baseline to end of study (Week 8)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Aliskiren 150 mg Tablet Aliskiren 300 mg Tablet Amlodipine 5 mg Capsule Amlodipine 10 mg Capsule Aliskiren/Amlodipine 150/5 mg Tablet Aliskiren/Amlodipine 150/10 mg Tablet Aliskiren/Amlodipine 300/5 mg Tablet Aliskiren/Amlodipine 300/10 mg Tablet
Hide Arm/Group Description Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. 150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. 300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
All-Cause Mortality
Placebo Aliskiren 150 mg Tablet Aliskiren 300 mg Tablet Amlodipine 5 mg Capsule Amlodipine 10 mg Capsule Aliskiren/Amlodipine 150/5 mg Tablet Aliskiren/Amlodipine 150/10 mg Tablet Aliskiren/Amlodipine 300/5 mg Tablet Aliskiren/Amlodipine 300/10 mg Tablet
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Aliskiren 150 mg Tablet Aliskiren 300 mg Tablet Amlodipine 5 mg Capsule Amlodipine 10 mg Capsule Aliskiren/Amlodipine 150/5 mg Tablet Aliskiren/Amlodipine 150/10 mg Tablet Aliskiren/Amlodipine 300/5 mg Tablet Aliskiren/Amlodipine 300/10 mg Tablet
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/198 (1.01%)   0/194 (0.00%)   0/203 (0.00%)   1/185 (0.54%)   1/181 (0.55%)   1/181 (0.55%)   2/181 (1.10%)   1/178 (0.56%)   1/184 (0.54%) 
Eye disorders                   
Retinal detachment  1  0/198 (0.00%)  0/194 (0.00%)  0/203 (0.00%)  0/185 (0.00%)  0/181 (0.00%)  0/181 (0.00%)  0/181 (0.00%)  0/178 (0.00%)  1/184 (0.54%) 
Gastrointestinal disorders                   
Abdominal mass  1  1/198 (0.51%)  0/194 (0.00%)  0/203 (0.00%)  0/185 (0.00%)  0/181 (0.00%)  0/181 (0.00%)  0/181 (0.00%)  0/178 (0.00%)  0/184 (0.00%) 
Infections and infestations                   
Bronchitis  1  0/198 (0.00%)  0/194 (0.00%)  0/203 (0.00%)  0/185 (0.00%)  0/181 (0.00%)  0/181 (0.00%)  1/181 (0.55%)  0/178 (0.00%)  0/184 (0.00%) 
Gastroenteritis  1  0/198 (0.00%)  0/194 (0.00%)  0/203 (0.00%)  0/185 (0.00%)  0/181 (0.00%)  0/181 (0.00%)  0/181 (0.00%)  1/178 (0.56%)  0/184 (0.00%) 
Pneumonia  1  0/198 (0.00%)  0/194 (0.00%)  0/203 (0.00%)  1/185 (0.54%)  1/181 (0.55%)  0/181 (0.00%)  0/181 (0.00%)  0/178 (0.00%)  0/184 (0.00%) 
Injury, poisoning and procedural complications                   
Hand fracture  1  1/198 (0.51%)  0/194 (0.00%)  0/203 (0.00%)  0/185 (0.00%)  0/181 (0.00%)  0/181 (0.00%)  0/181 (0.00%)  0/178 (0.00%)  0/184 (0.00%) 
Nervous system disorders                   
Cerebrovascular accident  1  0/198 (0.00%)  0/194 (0.00%)  0/203 (0.00%)  0/185 (0.00%)  0/181 (0.00%)  1/181 (0.55%)  0/181 (0.00%)  0/178 (0.00%)  0/184 (0.00%) 
Renal and urinary disorders                   
Calculus ureteric  1  0/198 (0.00%)  0/194 (0.00%)  0/203 (0.00%)  0/185 (0.00%)  0/181 (0.00%)  0/181 (0.00%)  1/181 (0.55%)  0/178 (0.00%)  0/184 (0.00%) 
Hydronephrosis  1  0/198 (0.00%)  0/194 (0.00%)  0/203 (0.00%)  0/185 (0.00%)  0/181 (0.00%)  0/181 (0.00%)  1/181 (0.55%)  0/178 (0.00%)  0/184 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Aliskiren 150 mg Tablet Aliskiren 300 mg Tablet Amlodipine 5 mg Capsule Amlodipine 10 mg Capsule Aliskiren/Amlodipine 150/5 mg Tablet Aliskiren/Amlodipine 150/10 mg Tablet Aliskiren/Amlodipine 300/5 mg Tablet Aliskiren/Amlodipine 300/10 mg Tablet
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/198 (11.11%)   15/194 (7.73%)   18/203 (8.87%)   18/185 (9.73%)   32/181 (17.68%)   15/181 (8.29%)   19/181 (10.50%)   8/178 (4.49%)   30/184 (16.30%) 
General disorders                   
Oedema peripheral  1  2/198 (1.01%)  2/194 (1.03%)  3/203 (1.48%)  8/185 (4.32%)  25/181 (13.81%)  4/181 (2.21%)  14/181 (7.73%)  2/178 (1.12%)  25/184 (13.59%) 
Nervous system disorders                   
Headache  1  20/198 (10.10%)  13/194 (6.70%)  15/203 (7.39%)  11/185 (5.95%)  8/181 (4.42%)  11/181 (6.08%)  8/181 (4.42%)  6/178 (3.37%)  5/184 (2.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
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Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
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Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00739973    
Other Study ID Numbers: CSPA100A2305
First Submitted: August 20, 2008
First Posted: August 22, 2008
Results First Submitted: January 13, 2011
Results First Posted: May 3, 2011
Last Update Posted: June 6, 2011