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Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension

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ClinicalTrials.gov Identifier: NCT00696241
Recruitment Status : Completed
First Posted : June 12, 2008
Results First Posted : April 19, 2011
Last Update Posted : July 29, 2011
Sponsor:
Information provided by:
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Azilsartan medoxomil and olmesartan
Drug: Olmesartan
Drug: Placebo
Enrollment 1275
Recruitment Details Participants enrolled at 147 investigative sites in Argentina, Mexico, Peru and the United States from 25 June 2007 to 08 October 2008.
Pre-assignment Details Participants with essential hypertension were enrolled in one of five, once-daily (QD) treatment groups.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
Period Title: Overall Study
Started 283 283 285 282 142
Completed 259 261 261 268 130
Not Completed 24 22 24 14 12
Reason Not Completed
Adverse Event             11             3             6             4             5
Protocol Violation             1             1             2             0             3
Lost to Follow-up             1             4             1             2             0
Withdrawal by Subject             4             8             6             1             0
Lack of Efficacy             1             5             4             5             3
Other             6             1             5             2             1
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD Total
Hide Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 283 283 285 282 142 1275
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 283 participants 283 participants 285 participants 282 participants 142 participants 1275 participants
<45 years 32 29 37 32 11 141
Between 45 and 64 years 173 187 161 153 84 758
≥65 years 78 67 87 97 47 376
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 283 participants 285 participants 282 participants 142 participants 1275 participants
Female
150
  53.0%
141
  49.8%
136
  47.7%
142
  50.4%
66
  46.5%
635
  49.8%
Male
133
  47.0%
142
  50.2%
149
  52.3%
140
  49.6%
76
  53.5%
640
  50.2%
1.Primary Outcome
Title Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 241 244 243 250 120
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-12.15  (0.709) -13.48  (0.704) -14.62  (0.706) -12.56  (0.696) -1.40  (1.004)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.75
Confidence Interval 95%
-13.17 to -8.34
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 terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.08
Confidence Interval (2-Sided) 95%
-14.48 to -9.67
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.21
Confidence Interval (2-Sided) 95%
-15.62 to -10.81
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.687
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
-1.55 to 2.35
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 0.352
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-2.87 to 1.02
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.038
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.06
Confidence Interval (2-Sided) 95%
-4.00 to -0.12
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 274 276 279 280 140
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-14.28  (0.956) -14.47  (0.952) -17.58  (0.947) -14.87  (0.945) -2.06  (1.337)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.23
Confidence Interval (2-Sided) 95%
-15.45 to -9.00
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 terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.42
Confidence Interval (2-Sided) 95%
-15.64 to -9.20
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.53
Confidence Interval (2-Sided) 95%
-18.74 to -12.31
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.662
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
-2.05 to 3.22
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 0.768
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
-2.24 to 3.03
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.043
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.71
Confidence Interval (2-Sided) 95%
-5.34 to -0.09
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 241 244 243 250 120
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-7.47  (0.458) -8.38  (0.455) -8.61  (0.456) -7.74  (0.449) -0.69  (0.649)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.78
Confidence Interval (2-Sided) 95%
-8.34 to -5.22
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.68
Confidence Interval (2-Sided) 95%
-9.24 to -6.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.92
Confidence Interval (2-Sided) 95%
-9.47 to -6.36
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.679
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-0.99 to 1.52
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 0.319
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-1.89 to 0.62
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.172
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-2.13 to 0.38
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
Hide Description The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 274 276 279 280 140
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-6.82  (0.535) -6.86  (0.533) -8.42  (0.530) -6.91  (0.529) 0.21  (0.749)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.02
Confidence Interval (2-Sided) 95%
-8.83 to -5.22
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.07
Confidence Interval (2-Sided) 95%
-8.87 to -5.27
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.62
Confidence Interval (2-Sided) 95%
-10.42 to -6.82
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.908
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-1.39 to 1.56
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 0.956
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-1.43 to 1.52
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.044
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.51
Confidence Interval (2-Sided) 95%
-2.98 to -0.04
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 241 244 243 250 120
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-12.57  (0.751) -13.75  (0.746) -14.96  (0.747) -12.73  (0.737) -1.54  (1.064)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.03
Confidence Interval (2-Sided) 95%
-13.59 to -8.48
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.20
Confidence Interval (2-Sided) 95%
-14.75 to -9.65
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.41
Confidence Interval (2-Sided) 95%
-15.97 to -10.86
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.879
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-1.90 to 2.22
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 0.334
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.01
Confidence Interval (2-Sided) 95%
-3.07 to 1.04
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.034
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.22
Confidence Interval (2-Sided) 95%
-4.28 to -0.16
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 241 244 243 250 120
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-7.71  (0.490) -8.43  (0.487) -8.87  (0.488) -7.82  (0.481) -0.59  (0.695)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.12
Confidence Interval (2-Sided) 95%
-8.79 to -5.45
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 P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.84
Confidence Interval (2-Sided) 95%
-9.51 to -6.18
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.28
Confidence Interval (2-Sided) 95%
-9.94 to -6.61
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.877
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-1.24 to 1.45
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 0.369
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-1.96 to 0.73
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.126
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.05
Confidence Interval (2-Sided) 95%
-2.39 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 241 244 243 250 120
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-11.10  (0.781) -12.39  (0.775) -13.35  (0.777) -12.13  (0.766) -0.97  (1.105)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.13
Confidence Interval (2-Sided) 95%
-12.79 to -7.48
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.43
Confidence Interval (2-Sided) 95%
-14.07 to -8.78
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.38
Confidence Interval (2-Sided) 95%
-15.03 to -9.73
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.346
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
-1.12 to 3.18
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 0.811
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-2.40 to 1.88
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.267
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-3.35 to 0.93
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 241 244 243 250 120
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-6.98  (0.533) -7.90  (0.530) -7.79  (0.531) -7.62  (0.523) -0.96  (0.755)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.03
Confidence Interval (2-Sided) 95%
-7.84 to -4.21
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.94
Confidence Interval (2-Sided) 95%
-8.75 to -5.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.84
Confidence Interval (2-Sided) 95%
-8.65 to -5.03
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.394
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
-0.83 to 2.10
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 0.712
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-1.74 to 1.19
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.818
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-1.63 to 1.29
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
Hide Description The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 241 244 243 250 120
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-12.72  (0.795) -14.05  (0.790) -15.18  (0.791) -13.07  (0.780) -1.36  (1.126)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.35
Confidence Interval (2-Sided) 95%
-14.05 to -8.64
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.68
Confidence Interval (2-Sided) 95%
-15.38 to -9.98
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.81
Confidence Interval (2-Sided) 95%
-16.51 to -11.11
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.750
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
-1.83 to 2.54
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 0.378
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.98
Confidence Interval (2-Sided) 95%
-3.16 to 1.20
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.059
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.10
Confidence Interval (2-Sided) 95%
-4.28 to 0.08
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 241 244 243 250 120
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-7.72  (0.519) -8.63  (0.516) -8.88  (0.517) -7.86  (0.510) -0.47  (0.736)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.25
Confidence Interval (2-Sided) 95%
-9.02 to -5.48
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.16
Confidence Interval (2-Sided) 95%
-9.92 to -6.40
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.41
Confidence Interval (2-Sided) 95%
-10.17 to -6.65
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.845
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
-1.29 to 1.57
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 0.290
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.77
Confidence Interval (2-Sided) 95%
-2.19 to 0.65
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.161
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.02
Confidence Interval (2-Sided) 95%
-2.44 to 0.41
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 241 244 242 250 120
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-12.15  (0.864) -12.39  (0.858) -13.42  (0.862) -11.10  (0.848) -1.21  (1.224)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.94
Confidence Interval (2-Sided) 95%
-13.88 to -8.00
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.18
Confidence Interval (2-Sided) 95%
-14.11 to -8.24
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.21
Confidence Interval (2-Sided) 95%
-15.15 to -9.28
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.385
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.05
Confidence Interval (2-Sided) 95%
-3.43 to 1.33
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 0.285
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.29
Confidence Interval (2-Sided) 95%
-3.66 to 1.08
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.054
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.33
Confidence Interval (2-Sided) 95%
-4.70 to 0.04
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 241 244 242 250 120
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-7.96  (0.614) -7.93  (0.610) -8.68  (0.612) -7.56  (0.603) -1.12  (0.870)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.84
Confidence Interval (2-Sided) 95%
-8.93 to -4.75
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.80
Confidence Interval (2-Sided) 95%
-8.89 to -4.72
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.55
Confidence Interval (2-Sided) 95%
-9.64 to -5.47
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.642
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-2.09 to 1.29
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 0.672
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-2.05 to 1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.196
Comments P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.11
Confidence Interval (2-Sided) 95%
-2.80 to 0.57
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 274 276 279 281 140
Measure Type: Number
Unit of Measure: percentage of participants
47.8 50.4 56.6 53.2 17.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.48
Confidence Interval (2-Sided) 95%
2.71 to 7.39
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 is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.97
Confidence Interval (2-Sided) 95%
3.01 to 8.20
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.53
Confidence Interval (2-Sided) 95%
3.95 to 10.79
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.173
Comments P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.57 to 1.11
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 0.449
Comments P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.63 to 1.23
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.402
Comments P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.83 to 1.62
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 274 276 279 281 140
Measure Type: Number
Unit of Measure: percentage of participants
67.5 71.0 73.5 73.9 47.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.86
Confidence Interval (2-Sided) 95%
1.82 to 4.48
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 is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.39
Confidence Interval (2-Sided) 95%
2.15 to 5.35
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.81
Confidence Interval (2-Sided) 95%
2.41 to 6.02
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.177
Comments P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.52 to 1.13
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 0.628
Comments P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.61 to 1.35
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.928
Comments P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.68 to 1.52
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description:
Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo-matching tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 274 276 279 281 140
Measure Type: Number
Unit of Measure: percentage of participants
42.7 45.3 52.0 47.5 14.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.53
Confidence Interval (2-Sided) 95%
2.66 to 7.72
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 is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.04
Confidence Interval (2-Sided) 95%
2.96 to 8.58
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.75
Confidence Interval (2-Sided) 95%
3.96 to 11.48
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20 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 0.217
Comments P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.58 to 1.13
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 0.537
Comments P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.64 to 1.26
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 0.276
Comments P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
0.86 to 1.68
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 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Hide Arm/Group Description Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks. Placebo-matching tablets, orally, once daily for up to 6 weeks.
All-Cause Mortality
Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 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 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/283 (2.83%)   0/281 (0.00%)   1/284 (0.35%)   2/282 (0.71%)   3/142 (2.11%) 
Cardiac disorders           
Atrial fibrillation  1  1/283 (0.35%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  0/142 (0.00%) 
Coronary artery disease  1  0/283 (0.00%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  1/142 (0.70%) 
Myocardial infarction  1  1/283 (0.35%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  0/142 (0.00%) 
Gastrointestinal disorders           
Gastrointestinal haemorrhage  1  0/283 (0.00%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  0/142 (0.00%) 
Inguinal hernia  1  0/283 (0.00%)  0/281 (0.00%)  0/284 (0.00%)  1/282 (0.35%)  0/142 (0.00%) 
General disorders           
Chest pain  1  0/283 (0.00%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  1/142 (0.70%) 
Hepatobiliary disorders           
Cholecystitis chronic  1  0/283 (0.00%)  0/281 (0.00%)  0/284 (0.00%)  1/282 (0.35%)  0/142 (0.00%) 
Infections and infestations           
Cellulitis  1  1/283 (0.35%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  0/142 (0.00%) 
Lower respiratory tract infection  1  1/283 (0.35%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  0/142 (0.00%) 
Pneumonia  1  1/283 (0.35%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  0/142 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Myelodysplastic syndrome  1  1/283 (0.35%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  0/142 (0.00%) 
Nervous system disorders           
Epilepsy  1  1/283 (0.35%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  0/142 (0.00%) 
Ischaemic stroke  1  1/283 (0.35%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  0/142 (0.00%) 
Transient ischaemic attack  1  0/283 (0.00%)  0/281 (0.00%)  1/284 (0.35%)  0/282 (0.00%)  0/142 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Status asthmaticus  1  1/283 (0.35%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  0/142 (0.00%) 
Vascular disorders           
Ischaemia  1  0/283 (0.00%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  1/142 (0.70%) 
Shock  1  1/283 (0.35%)  0/281 (0.00%)  0/284 (0.00%)  0/282 (0.00%)  0/142 (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 20 mg QD Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil 80 mg QD Olmesartan 40 mg QD Placebo QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/283 (8.13%)   19/281 (6.76%)   32/284 (11.27%)   18/282 (6.38%)   13/142 (9.15%) 
Metabolism and nutrition disorders           
Dyslipidemia  1  10/283 (3.53%)  11/281 (3.91%)  16/284 (5.63%)  10/282 (3.55%)  3/142 (2.11%) 
Nervous system disorders           
Headache  1  13/283 (4.59%)  9/281 (3.20%)  16/284 (5.63%)  9/282 (3.19%)  10/142 (7.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00696241     History of Changes
Other Study ID Numbers: 01-05-TL-491-008
U1111-1113-8905 ( 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: July 29, 2011