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Efficacy and Safety of Azilsartan Medoxomil, Once Daily (QD), Co-Administered With Amlodipine in Participants With Essential Hypertension

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ClinicalTrials.gov Identifier: NCT00591266
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : April 19, 2011
Last Update Posted : July 22, 2011
Sponsor:
Information provided by:
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Azilsartan Medoxomil and amlodipine
Drug: Amlodipine
Enrollment 566

Recruitment Details Participants enrolled at 65 investigative sites in Argentina, Chile, Mexico, Peru and the United States from 03 October 2007 to 03 April 2009.
Pre-assignment Details Participants with uncontrolled hypertension were enrolled in one of three, once-daily (QD) treatment groups.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks. Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Period Title: Overall Study
Started 189 [1] 188 [1] 189 [1]
Completed 180 177 175
Not Completed 9 11 14
Reason Not Completed
Adverse Event             2             2             3
Lost to Follow-up             0             1             0
Protocol Violation             0             0             1
Withdrawal by Subject             6             2             5
Lack of Efficacy             0             2             0
Other             1             4             5
[1]
Randomized only
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD Total
Hide Arm/Group Description Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks. Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 189 188 189 566
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 189 participants 188 participants 189 participants 566 participants
<45 years 28 23 15 66
Between 45 and 64 years 97 111 115 323
≥65 years 64 54 59 177
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 188 participants 189 participants 566 participants
Female
99
  52.4%
85
  45.2%
95
  50.3%
279
  49.3%
Male
90
  47.6%
103
  54.8%
94
  49.7%
287
  50.7%
1.Primary Outcome
Title Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 165 166 166
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-24.79  (0.757) -24.51  (0.754) -13.60  (0.754)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.19
Confidence Interval (2-Sided) 95%
-13.29 to -9.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.91
Confidence Interval (2-Sided) 95%
-13.00 to -8.81
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.
Hide Description The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 187 183 179
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-26.96  (1.037) -25.50  (1.048) -15.94  (1.060)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.02
Confidence Interval (2-Sided) 95%
-13.93 to -8.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.56
Confidence Interval (2-Sided) 95%
-12.48 to -6.63
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 165 166 166
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-15.26  (0.492) -15.43  (0.490) -7.79  (0.490)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.48
Confidence Interval (2-Sided) 95%
-8.84 to -6.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.65
Confidence Interval (2-Sided) 95%
-9.01 to -6.28
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
Hide Description The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 187 183 179
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-12.00  (0.602) -12.65  (0.609) -7.07  (0.616)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.93
Confidence Interval (2-Sided) 95%
-6.62 to -3.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.58
Confidence Interval (2-Sided) 95%
-7.28 to -3.88
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 165 166 166
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-25.42  (0.802) -24.95  (0.800) -13.79  (0.799)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.64
Confidence Interval (2-Sided) 95%
-13.86 to -9.41
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.17
Confidence Interval (2-Sided) 95%
-13.39 to -8.95
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 165 166 166
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-15.81  (0.535) -15.86  (0.533) -7.82  (0.533)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.99
Confidence Interval (2-Sided) 95%
-9.47 to -6.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.04
Confidence Interval (2-Sided) 95%
-9.52 to -6.55
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 165 166 166
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-22.75  (0.853) -22.72  (0.849) -13.05  (0.848)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.70
Confidence Interval (2-Sided) 95%
-12.07 to -7.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.67
Confidence Interval (2-Sided) 95%
-12.03 to -7.31
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 165 166 166
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-13.76  (0.606) -13.78  (0.604) -7.50  (0.604)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.26
Confidence Interval (2-Sided) 95%
-7.94 to -4.57
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.28
Confidence Interval (2-Sided) 95%
-7.96 to -4.60
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
Hide Description The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 165 166 166
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-26.10  (0.850) -25.40  (0.847) -13.82  (0.846)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.27
Confidence Interval (2-Sided) 95%
-14.63 to -9.92
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.58
Confidence Interval (2-Sided) 95%
-13.93 to -9.23
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
Hide Description The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 165 166 166
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-16.13  (0.575) -15.97  (0.574) -7.74  (0.574)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.39
Confidence Interval (2-Sided) 95%
-9.98 to -6.79
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.23
Confidence Interval (2-Sided) 95%
-9.82 to -6.64
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 165 166 166
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-22.60  (0.942) -22.67  (0.938) -13.76  (0.938)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.83
Confidence Interval (2-Sided) 95%
-11.45 to -6.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.91
Confidence Interval (2-Sided) 95%
-11.51 to -6.30
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 165 166 166
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-14.34  (0.698) -14.93  (0.696) -8.39  (0.696)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.94
Confidence Interval (2-Sided) 95%
-7.88 to -4.00
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.54
Confidence Interval (2-Sided) 95%
-8.47 to -4.61
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg
Hide Description Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6 relative to baseline, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 187 183 179
Measure Type: Number
Unit of Measure: percentage of participants
72.7 71.6 45.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.37
Confidence Interval (2-Sided) 95%
2.15 to 5.26
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.21
Confidence Interval (2-Sided) 95%
2.05 to 5.03
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg
Hide Description Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6 relative to baseline, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of 3 trough sitting diastolic blood pressure measurements.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 187 183 179
Measure Type: Number
Unit of Measure: percentage of participants
86.1 87.4 65.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.54
Confidence Interval (2-Sided) 95%
2.08 to 6.02
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.90
Confidence Interval (2-Sided) 95%
2.25 to 6.75
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response
Hide Description Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6 relative to baseline, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description:
Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 187 183 179
Measure Type: Number
Unit of Measure: percentage of participants
65.8 69.4 43.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.62
Confidence Interval (2-Sided) 95%
1.71 to 4.02
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD, Amlodipine 5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.12
Confidence Interval (2-Sided) 95%
2.01 to 4.82
Estimation Comments [Not Specified]
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Hide Arm/Group Description Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks. Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
All-Cause Mortality
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/190 (0.53%)   2/188 (1.06%)   1/185 (0.54%) 
General disorders       
Chest pain  1  0/190 (0.00%)  0/188 (0.00%)  1/185 (0.54%) 
Infections and infestations       
Urinary tract infection  1  0/190 (0.00%)  1/188 (0.53%)  0/185 (0.00%) 
Nervous system disorders       
Syncope  1  1/190 (0.53%)  0/188 (0.00%)  0/185 (0.00%) 
Reproductive system and breast disorders       
Ovarian cyst torsion  1  0/190 (0.00%)  1/188 (0.53%)  0/185 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Amlodipine 5 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/190 (5.79%)   10/188 (5.32%)   10/185 (5.41%) 
Nervous system disorders       
Headache  1  11/190 (5.79%)  10/188 (5.32%)  10/185 (5.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
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.
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00591266     History of Changes
Other Study ID Numbers: 01-05-TL-491-010
U1111-1113-9132 ( Registry Identifier: WHO )
First Submitted: December 27, 2007
First Posted: January 11, 2008
Results First Submitted: March 24, 2011
Results First Posted: April 19, 2011
Last Update Posted: July 22, 2011