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Trial record 72 of 134 for:    OLMESARTAN

An Efficacy and Safety Study of Azilsartan Medoxomil Compared to Valsartan and Olmesartan in Participants With 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: NCT00696436
Recruitment Status : Completed
First Posted : June 12, 2008
Results First Posted : April 19, 2011
Last Update Posted : April 19, 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
Drug: Valsartan
Drug: Olmesartan
Drug: Placebo
Enrollment 1291
Recruitment Details Participants enrolled at 141 investigative sites in Guatemala, Mexico, Peru, Puerto Rico and the United States from 02 April 2008 to 19 August 2009.
Pre-assignment Details Participants with essential hypertension were enrolled in one of five, once-daily (QD) treatment groups.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Period Title: Overall Study
Started 280 [1] 285 [2] 282 [1] 290 [1] 154 [1]
Completed 257 255 254 268 141
Not Completed 23 30 28 22 13
Reason Not Completed
Adverse Event             7             9             8             6             4
Protocol Violation             3             2             2             0             1
Lost to Follow-up             1             6             2             4             3
Withdrawal by Subject             4             11             5             7             1
Lack of Efficacy             3             1             5             2             4
Participant Unavailability             2             0             2             1             0
Administrative Error             2             0             2             0             0
Participant Non-compliance             0             0             1             2             0
Administrative Decision             1             0             0             0             0
Missing             0             1             1             0             0
[1]
Randomized participants only.
[2]
Randomized participants only. One participant treated but not randomized and is not included.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD Total
Hide Arm/Group Description

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks. Total of all reporting groups
Overall Number of Baseline Participants 280 285 282 290 154 1291
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 280 participants 285 participants 282 participants 290 participants 154 participants 1291 participants
<45 years 41 38 56 39 20 194
Between 45 and 64 years 170 184 178 185 98 815
≥65 years 69 63 48 66 36 282
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 285 participants 282 participants 290 participants 154 participants 1291 participants
Female
133
  47.5%
134
  47.0%
130
  46.1%
131
  45.2%
64
  41.6%
592
  45.9%
Male
147
  52.5%
151
  53.0%
152
  53.9%
159
  54.8%
90
  58.4%
699
  54.1%
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 237 229 234 254 134
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-13.42  (0.690) -14.53  (0.702) -10.22  (0.696) -11.99  (0.666) -0.25  (0.917)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.27
Confidence Interval (2-Sided) 95%
-16.54 to -12.01
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.16
Confidence Interval (2-Sided) 95%
-15.41 to -10.91
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.54
Confidence Interval (2-Sided) 95%
-4.44 to -0.64
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.31
Confidence Interval (2-Sided) 95%
-6.25 to -2.37
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.136
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.43
Confidence Interval (2-Sided) 95%
-3.31 to 0.45
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.20
Confidence Interval (2-Sided) 95%
-5.12 to -1.27
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.
Time Frame Baseline and Week 6.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 269 270 271 283 148
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-16.38  (0.959) -16.74  (0.957) -11.31  (0.955) -13.20  (0.935) -1.83  (1.293)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.92
Confidence Interval (2-Sided) 95%
-18.07 to -11.76
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.55
Confidence Interval (2-Sided) 95%
-17.71 to -11.40
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.54
Confidence Interval (2-Sided) 95%
-6.17 to -0.92
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.43
Confidence Interval (2-Sided) 95%
-8.09 to -2.78
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.18
Confidence Interval (2-Sided) 95%
-5.81 to -0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.07
Confidence Interval (2-Sided) 95%
-7.73 to -2.42
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 237 229 234 254 134
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-8.65  (0.472) -9.43  (0.480) -7.09  (0.476) -7.74  (0.456) -0.07  (0.627)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.36
Confidence Interval (2-Sided) 95%
-10.91 to -7.81
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.58
Confidence Interval (2-Sided) 95%
-10.12 to -7.04
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.70
Confidence Interval (2-Sided) 95%
-2.99 to -0.40
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.35
Confidence Interval (2-Sided) 95%
-3.67 to -1.02
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.166
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-2.19 to 0.38
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.56
Confidence Interval (2-Sided) 95%
-2.88 to -0.24
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 systolic blood pressure measured at final visit or week 6 relative to baseline.
Time Frame Baseline and Week 6.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 269 270 271 283 148
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-6.97  (0.552) -8.27  (0.551) -5.11  (0.550) -6.10  (0.538) -0.76  (0.744)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.51
Confidence Interval (2-Sided) 95%
-9.33 to -5.69
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.21
Confidence Interval (2-Sided) 95%
-8.03 to -4.39
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.18
Confidence Interval (2-Sided) 95%
-3.69 to -0.67
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.17
Confidence Interval (2-Sided) 95%
-4.69 to -1.64
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.257
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-2.39 to 0.64
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.86
Confidence Interval (2-Sided) 95%
-3.39 to -0.33
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 237 229 234 254 134
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-13.73  (0.724) -15.02  (0.736) -10.26  (0.730) -12.16  (0.699) -0.11  (0.963)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.92
Confidence Interval (2-Sided) 95%
-17.30 to -12.54
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.63
Confidence Interval (2-Sided) 95%
-15.99 to -11.27
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.86
Confidence Interval (2-Sided) 95%
-4.85 to -0.87
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.76
Confidence Interval (2-Sided) 95%
-6.80 to -2.73
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.119
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.57
Confidence Interval (2-Sided) 95%
-3.55 to 0.40
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.47
Confidence Interval (2-Sided) 95%
-5.49 to -1.45
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 237 229 234 254 134
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-8.96  (0.510) -9.80  (0.518) -7.23  (0.514) -7.82  (0.492) 0.01  (0.677)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.81
Confidence Interval (2-Sided) 95%
-11.48 to -8.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.96
Confidence Interval (2-Sided) 95%
-10.63 to -7.30
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.99
Confidence Interval (2-Sided) 95%
-3.39 to -0.58
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.57
Confidence Interval (2-Sided) 95%
-4.00 to -1.14
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.14
Confidence Interval (2-Sided) 95%
-2.53 to 0.25
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.73
Confidence Interval (2-Sided) 95%
-3.15 to -0.30
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 237 229 234 254 134
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-12.28  (0.778) -13.32  (0.792) -9.66  (0.784) -11.90  (0.752) -0.31  (1.035)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.00
Confidence Interval (2-Sided) 95%
-15.56 to -10.45
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.97
Confidence Interval (2-Sided) 95%
-14.51 to -9.43
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.194
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.42
Confidence Interval (2-Sided) 95%
-3.56 to 0.72
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.65
Confidence Interval (2-Sided) 95%
-5.84 to -1.46
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.720
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-2.51 to 1.73
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.62
Confidence Interval (2-Sided) 95%
-4.79 to -0.45
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 237 229 234 254 134
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-7.65  (0.540) -8.54  (0.550) -6.26  (0.544) -7.82  (0.522) 0.10  (0.718)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.64
Confidence Interval (2-Sided) 95%
-10.42 to -6.87
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.75
Confidence Interval (2-Sided) 95%
-9.52 to -5.99
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.341
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-2.21 to 0.77
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.28
Confidence Interval (2-Sided) 95%
-3.80 to -0.76
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.821
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-1.30 to 1.64
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.39
Confidence Interval (2-Sided) 95%
-2.89 to 0.12
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 237 229 234 254 134
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-14.03  (0.764) -15.55  (0.777) -10.44  (0.770) -12.23  (0.738) -0.10  (1.016)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.45
Confidence Interval (2-Sided) 95%
-17.96 to -12.94
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.93
Confidence Interval (2-Sided) 95%
-16.42 to -11.43
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.32
Confidence Interval (2-Sided) 95%
-5.42 to -1.22
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.11
Confidence Interval (2-Sided) 95%
-7.26 to -2.97
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.80
Confidence Interval (2-Sided) 95%
-3.88 to 0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.59
Confidence Interval (2-Sided) 95%
-5.72 to -1.46
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 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 237 229 234 254 134
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-9.16  (0.542) -10.13  (0.551) -7.42  (0.547) -7.82  (0.524) 0.01  (0.721)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.14
Confidence Interval (2-Sided) 95%
-11.92 to -8.36
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.17
Confidence Interval (2-Sided) 95%
-10.94 to -7.40
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.31
Confidence Interval (2-Sided) 95%
-3.81 to -0.82
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.71
Confidence Interval (2-Sided) 95%
-4.24 to -1.19
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.34
Confidence Interval (2-Sided) 95%
-2.82 to 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.74
Confidence Interval (2-Sided) 95%
-3.25 to -0.22
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 236 229 234 254 134
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-12.46  (0.860) -13.38  (0.873) -9.14  (0.865) -11.65  (0.829) -0.55  (1.142)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.84
Confidence Interval (2-Sided) 95%
-15.66 to -10.02
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.91
Confidence Interval (2-Sided) 95%
-14.72 to -9.11
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.149
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.74
Confidence Interval (2-Sided) 95%
-4.10 to 0.62
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.24
Confidence Interval (2-Sided) 95%
-6.65 to -1.83
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.494
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.82
Confidence Interval (2-Sided) 95%
-3.16 to 1.53
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.32
Confidence Interval (2-Sided) 95%
-5.72 to -0.93
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 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 trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Time Frame Baseline and Week 6.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 236 229 234 254 134
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-8.69  (0.648) -8.61  (0.657) -6.22  (0.651) -8.25  (0.624) -0.69  (0.859)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.91
Confidence Interval (2-Sided) 95%
-10.03 to -5.79
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.99
Confidence Interval (2-Sided) 95%
-10.10 to -5.88
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.691
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-2.14 to 1.42
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.39
Confidence Interval (2-Sided) 95%
-4.20 to -0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.625
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-2.20 to 1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.46
Confidence Interval (2-Sided) 95%
-4.27 to -0.66
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, 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 269 270 271 283 148
Measure Type: Number
Unit of Measure: percentage of participants
56.5 57.8 48.7 48.8 22.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.98
Confidence Interval (2-Sided) 95%
3.15 to 7.88
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.66
Confidence Interval (2-Sided) 95%
2.94 to 7.37
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
1.03 to 2.03
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.46
Confidence Interval (2-Sided) 95%
1.04 to 2.06
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
0.96 to 1.89
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
0.97 to 1.92
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, 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 the 3 trough sitting diastolic blood pressure measurements.
Time Frame Baseline and Week 6.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 269 270 271 283 148
Measure Type: Number
Unit of Measure: percentage of participants
68.8 71.1 63.8 68.2 43.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.29
Confidence Interval (2-Sided) 95%
2.10 to 5.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.91
Confidence Interval (2-Sided) 95%
1.86 to 4.54
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.306
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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.83 to 1.80
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.132
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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
0.92 to 1.97
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.695
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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.74 to 1.58
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.381
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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.81 to 1.74
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, 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
Overall Number of Participants Analyzed 269 270 271 283 148
Measure Type: Number
Unit of Measure: percentage of participants
49.1 52.6 43.9 44.5 18.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Placebo 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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.18
Confidence Interval (2-Sided) 95%
3.20 to 8.41
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Placebo 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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.43
Confidence Interval (2-Sided) 95%
2.73 to 7.19
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
0.99 to 1.94
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
1.02 to 2.02
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Olmesartan 40 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.317
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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.85 to 1.66
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD, Valsartan 320 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
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 was presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.87 to 1.73
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 Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Matching placebo, orally, once daily for up to six weeks.
All-Cause Mortality
Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/280 (0.71%)   3/284 (1.06%)   3/277 (1.08%)   4/290 (1.38%)   2/155 (1.29%) 
Eye disorders           
Eye irritation  1  0/280 (0.00%)  1/284 (0.35%)  0/277 (0.00%)  0/290 (0.00%)  0/155 (0.00%) 
Gastrointestinal disorders           
Abdominal adhesions  1  0/280 (0.00%)  0/284 (0.00%)  0/277 (0.00%)  0/290 (0.00%)  1/155 (0.65%) 
Gastrointestinal haemorrhage  1  0/280 (0.00%)  1/284 (0.35%)  0/277 (0.00%)  0/290 (0.00%)  0/155 (0.00%) 
Hepatobiliary disorders           
Cholecystitis  1  1/280 (0.36%)  0/284 (0.00%)  0/277 (0.00%)  0/290 (0.00%)  0/155 (0.00%) 
Cholelithiasis  1  1/280 (0.36%)  0/284 (0.00%)  0/277 (0.00%)  0/290 (0.00%)  0/155 (0.00%) 
Infections and infestations           
Cellulitis  1  0/280 (0.00%)  0/284 (0.00%)  0/277 (0.00%)  1/290 (0.34%)  0/155 (0.00%) 
Diverticulitis  1  0/280 (0.00%)  1/284 (0.35%)  0/277 (0.00%)  0/290 (0.00%)  0/155 (0.00%) 
Infected bites  1  0/280 (0.00%)  0/284 (0.00%)  0/277 (0.00%)  1/290 (0.34%)  0/155 (0.00%) 
Injury, poisoning and procedural complications           
Fall  1  0/280 (0.00%)  0/284 (0.00%)  1/277 (0.36%)  0/290 (0.00%)  1/155 (0.65%) 
Intentional overdose  1  0/280 (0.00%)  0/284 (0.00%)  1/277 (0.36%)  0/290 (0.00%)  0/155 (0.00%) 
Subdural haematoma  1  0/280 (0.00%)  0/284 (0.00%)  0/277 (0.00%)  1/290 (0.34%)  0/155 (0.00%) 
Investigations           
Blood pressure increased  1  0/280 (0.00%)  1/284 (0.35%)  0/277 (0.00%)  0/290 (0.00%)  0/155 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Breast cancer  1  0/280 (0.00%)  0/284 (0.00%)  0/277 (0.00%)  1/290 (0.34%)  0/155 (0.00%) 
Nervous system disorders           
Partial seizures  1  0/280 (0.00%)  0/284 (0.00%)  0/277 (0.00%)  1/290 (0.34%)  0/155 (0.00%) 
Reproductive system and breast disorders           
Dysfunctional uterine bleeding  1  1/280 (0.36%)  0/284 (0.00%)  0/277 (0.00%)  0/290 (0.00%)  0/155 (0.00%) 
Vascular disorders           
Deep vein thrombosis  1  0/280 (0.00%)  0/284 (0.00%)  1/277 (0.36%)  0/290 (0.00%)  0/155 (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 Azilsartan Medoxomil 80 mg QD Valsartan 320 mg QD Olmesartan 40 mg QD Placebo QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/280 (6.43%)   12/284 (4.23%)   21/277 (7.58%)   23/290 (7.93%)   14/155 (9.03%) 
Nervous system disorders           
Headache  1  18/280 (6.43%)  12/284 (4.23%)  21/277 (7.58%)  23/290 (7.93%)  14/155 (9.03%) 
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.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
EMail: clinicaltrialregistry@tpna.com
Layout table for additonal information
Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00696436     History of Changes
Other Study ID Numbers: 01-06-TL-491-019
U1111-1113-9161 ( Registry Identifier: WHO )
First Submitted: June 10, 2008
First Posted: June 12, 2008
Results First Submitted: March 24, 2011
Results First Posted: April 19, 2011
Last Update Posted: April 19, 2011