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Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus (ViVID)

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ClinicalTrials.gov Identifier: NCT00927394
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : October 31, 2012
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Aliskiren
Drug: Valsartan
Drug: Placebo for Aliskiren
Drug: Placebo for Valsartan
Enrollment 1143
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Period Title: Overall Study
Started 575 568 [1]
Cohort 1 (Randomized) 157 [2] 165
Cohort 2 (Randomized) 418 [3] 403
Combined Safety Set (Cohort 1 and 2) 574 565
Cohort 1: Full Analysis Set 1 (FAS 1) 157 [4] 164
Cohort 2: Full Analysis Set 2 (FAS 2) 417 [5] 398
FAS 2 :Ambulatory Blood Pressure Monitor 342 [6] 323
Combined Full Analysis Set (FAS 1+FAS 2) 574 562
Completed 498 483
Not Completed 77 85
Reason Not Completed
Adverse Event             14             9
Unsatisfactory therapeutic effect             17             23
Withdrawal by Subject             20             24
Lost to Follow-up             8             14
Administrative Problem             1             0
Death             1             1
Protocol deviation             16             13
Randomized in error             0             1
[1]
One patient was randomized in error and was discontinued by site.
[2]
Cohort 1 includes patients with specific eligibility criteria mentioned in protocol section
[3]
Cohort 2 includes patients with specific eligibility criteria mentioned in protocol section
[4]
FAS 1 includes all patients in Cohort 1 to whom study treatments were given through randomization.
[5]
FAS 2= all patients randomized to Cohort 2 and who had a valid baseline assessment of 24 hours ABPM.
[6]
consists of all patients in FAS 2 who had both valid baseline and post-baseline ABPM assessments.
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan Total
Hide Arm/Group Description To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 574 565 1139
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 574 participants 565 participants 1139 participants
55.0  (9.30) 55.2  (9.60) 55.1  (9.44)
[1]
Measure Description: Demographic measures were based on Safety set.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 574 participants 565 participants 1139 participants
Female
233
  40.6%
244
  43.2%
477
  41.9%
Male
341
  59.4%
321
  56.8%
662
  58.1%
1.Primary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8
Hide Description The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.
Time Frame baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)- Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description:
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Overall Number of Participants Analyzed 342 323
Mean (Standard Deviation)
Unit of Measure: mmHg
-15.3  (14.62) -11.5  (14.75)
2.Secondary Outcome
Title Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Hide Description Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.
Time Frame Baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description:
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Overall Number of Participants Analyzed 562 553
Mean (Standard Deviation)
Unit of Measure: mmHg
-21.7  (18.70) -18.2  (18.06)
3.Secondary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8
Hide Description The 24-hour ambulatory diastolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly diastolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MADBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.
Time Frame baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)- Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description:
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Overall Number of Participants Analyzed 342 323
Mean (Standard Deviation)
Unit of Measure: mmHg
-9.2  (8.80) -6.7  (8.82)
4.Secondary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8
Hide Description The 24-hour ambulatory pulse pressure was evaluated at baseline (Week 0) and post-baseline visits.
Time Frame baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)- Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description:
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Overall Number of Participants Analyzed 342 323
Mean (Standard Deviation)
Unit of Measure: mmHg
-6.1  (8.58) -4.7  (8.26)
5.Secondary Outcome
Title Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Hide Description Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.
Time Frame Baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description:
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Overall Number of Participants Analyzed 562 553
Mean (Standard Deviation)
Unit of Measure: mmHg
-11.0  (10.58) -8.3  (10.60)
6.Secondary Outcome
Title Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8
Hide Description At each visit, the pulse rate was measured for 30 seconds just prior to the first sitting blood pressure measurement.
Time Frame baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description:
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Overall Number of Participants Analyzed 562 553
Mean (Standard Deviation)
Unit of Measure: mmHg
-10.8  (13.46) -9.9  (13.83)
7.Secondary Outcome
Title Percentage of Patients Achieving Blood Pressure Control
Hide Description Blood pressure control was defined as MSSBP/MSDBP <140/90 mmHg. Percentage of patients achieving of blood pressure control at the corresponding visit was reported
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Number of patients with data at each visit were analyzed.
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description:
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Overall Number of Participants Analyzed 514 498
Measure Type: Number
Unit of Measure: Percentage of patients
39.9 32.7
8.Secondary Outcome
Title Percentage of Responders
Hide Description Responders were defined as patients with MSSBP <130 mmHg or a reduction from baseline in MSSBP of >20 mmHg.Percentage of responders achieving a response at the corresponding visit was reported.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description:
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Overall Number of Participants Analyzed 514 498
Measure Type: Number
Unit of Measure: Percentage of patients
61.9 53.8
9.Secondary Outcome
Title Change From Baseline in Plasma Renin Activity (PRA) at Week 8
Hide Description [Not Specified]
Time Frame Baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description:
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Overall Number of Participants Analyzed 429 409
Mean (Standard Deviation)
Unit of Measure: ng/mL/hr
1.056  (4.966) 0.879  (4.646)
10.Secondary Outcome
Title Change From Baseline in Plasma Renin Concentration (PRC) at Week 8
Hide Description [Not Specified]
Time Frame Baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description:
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Overall Number of Participants Analyzed 428 404
Mean (Standard Deviation)
Unit of Measure: ng/L
68.592  (209.544) 124.721  (489.719)
11.Secondary Outcome
Title Change From Baseline in Plasma Aldosterone at Week 8
Hide Description [Not Specified]
Time Frame Baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description:
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Overall Number of Participants Analyzed 431 411
Mean (Standard Deviation)
Unit of Measure: pmol/L
-21.957  (115.251) -22.562  (123.343)
12.Secondary Outcome
Title Number of Patients With Adverse Events, Serious Adverse Events and Death
Hide Description

Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.

Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set - Consisted of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description:
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Overall Number of Participants Analyzed 574 565
Measure Type: Number
Unit of Measure: Patients
Adverse Events 202 182
Serious Adverse events 9 9
Death 1 1
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
 
Arm/Group Title Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Hide Arm/Group Description To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks. To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
All-Cause Mortality
Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Affected / at Risk (%) Affected / at Risk (%)
Total   9/574 (1.57%)   9/565 (1.59%) 
Cardiac disorders     
Angina pectoris  1  1/574 (0.17%)  0/565 (0.00%) 
Angina unstable  1  1/574 (0.17%)  0/565 (0.00%) 
Atrial fibrillation  1  1/574 (0.17%)  0/565 (0.00%) 
Cardiac failure congestive  1  1/574 (0.17%)  1/565 (0.18%) 
Myocardial ischaemia  1  0/574 (0.00%)  1/565 (0.18%) 
General disorders     
Non-cardiac chest pain  1  1/574 (0.17%)  1/565 (0.18%) 
Infections and infestations     
Pharyngotonsillitis  1  1/574 (0.17%)  0/565 (0.00%) 
Sweat gland infection  1  0/574 (0.00%)  1/565 (0.18%) 
Injury, poisoning and procedural complications     
Heat exhaustion  1  0/574 (0.00%)  1/565 (0.18%) 
Injury  1  1/574 (0.17%)  0/565 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/574 (0.00%)  1/565 (0.18%) 
Nervous system disorders     
Cerebrovascular accident  1  1/574 (0.17%)  0/565 (0.00%) 
Convulsion  1  0/574 (0.00%)  1/565 (0.18%) 
Paraesthesia  1  1/574 (0.17%)  0/565 (0.00%) 
Psychiatric disorders     
Major depression  1  0/574 (0.00%)  1/565 (0.18%) 
Renal and urinary disorders     
Renal failure acute  1  0/574 (0.00%)  1/565 (0.18%) 
Urinary retention  1  0/574 (0.00%)  1/565 (0.18%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/574 (0.00%)  1/565 (0.18%) 
Pneumothorax  1  1/574 (0.17%)  0/565 (0.00%) 
Respiratory failure  1  0/574 (0.00%)  1/565 (0.18%) 
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%
Combination Therapy: Aliskiren + Valsartan Monotherapy: Valsartan
Affected / at Risk (%) Affected / at Risk (%)
Total   34/574 (5.92%)   36/565 (6.37%) 
Nervous system disorders     
Headache  1  34/574 (5.92%)  36/565 (6.37%) 
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 or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Directors
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00927394    
Other Study ID Numbers: CSPV100AUS02
First Submitted: June 24, 2009
First Posted: June 25, 2009
Results First Submitted: October 1, 2012
Results First Posted: October 31, 2012
Last Update Posted: December 6, 2012