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Efficacy and Safety of Azilsartan Medoxomil Co-Administered With Chlorthalidone in Participants With Essential Hypertension

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ClinicalTrials.gov Identifier: NCT00591773
Recruitment Status : Completed
First Posted : January 11, 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 and chlorthalidone
Drug: Chlorthalidone
Enrollment 551
Recruitment Details Participants enrolled at 74 investigative sites in Argentina, Chile, Mexico, Peru and the United States from 07 September 2007 to 05 March 2009.
Pre-assignment Details Participants with uncontrolled essential hypertension were enrolled in one of three, once-daily (QD) treatment groups.
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks. Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Period Title: Overall Study
Started 185 182 184
Completed 169 158 168
Not Completed 16 24 16
Reason Not Completed
Adverse Event             9             9             6
Protocol Violation             2             3             0
Lost to Follow-up             1             4             1
Withdrawal by Subject             2             5             3
Lack of Efficacy             1             2             2
Other             1             1             4
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD Total
Hide Arm/Group Description Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks. Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 185 182 184 551
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 185 participants 182 participants 184 participants 551 participants
<45 years 21 15 16 52
Between 45 and 64 years 114 110 113 337
≥65 years 50 57 55 162
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 182 participants 184 participants 551 participants
Female
96
  51.9%
88
  48.4%
82
  44.6%
266
  48.3%
Male
89
  48.1%
94
  51.6%
102
  55.4%
285
  51.7%
1.Primary Outcome
Title Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 149 147 152
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-31.72  (0.966) -31.30  (0.973) -15.85  (0.957)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.86
Confidence Interval (2-Sided) 95%
-18.54 to -13.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.45
Confidence Interval (2-Sided) 95%
-18.13 to -12.76
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.
Hide Description The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 179 176 178
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-36.16  (1.226) -34.44  (1.236) -21.76  (1.229)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.40
Confidence Interval (2-Sided) 95%
-17.81 to -10.99
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.68
Confidence Interval (2-Sided) 95%
-16.10 to -9.25
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 149 147 152
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-18.28  (0.626) -18.49  (0.630) -7.99  (0.619)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.29
Confidence Interval (2-Sided) 95%
-12.02 to -8.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.49
Confidence Interval (2-Sided) 95%
-12.23 to -8.76
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure.
Hide Description The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 179 176 178
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-16.18  (0.717) -15.98  (0.723) -8.93  (0.719)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.25
Confidence Interval (2-Sided) 95%
-9.25 to -5.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.05
Confidence Interval (2-Sided) 95%
-9.06 to -5.05
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 149 147 152
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-32.53  (0.996) -31.97  (1.003) -15.73  (0.988)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.80
Confidence Interval (2-Sided) 95%
-19.56 to -14.04
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.24
Confidence Interval (2-Sided) 95%
-19.01 to -13.47
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 149 147 152
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-18.82  (0.665) -18.99  (0.670) -7.79  (0.659)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.02
Confidence Interval (2-Sided) 95%
-12.86 to -9.18
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.20
Confidence Interval (2-Sided) 95%
-13.04 to -9.35
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 149 147 152
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-29.52  (1.080) -29.43  (1.087) -16.59  (1.069)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.93
Confidence Interval (2-Sided) 95%
-15.92 to -9.94
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.84
Confidence Interval (2-Sided) 95%
-15.83 to -9.84
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 149 147 152
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-17.05  (0.714) -17.06  (0.718) -8.89  (0.707)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.16
Confidence Interval (2-Sided) 95%
-10.14 to -6.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.17
Confidence Interval (2-Sided) 95%
-10.15 to -6.19
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 149 147 152
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-33.02  (1.039) -32.45  (1.048) -15.50  (1.031)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.52
Confidence Interval (2-Sided) 95%
-20.39 to -14.64
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.95
Confidence Interval (2-Sided) 95%
-19.84 to -14.05
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.
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 149 147 152
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-19.06  (0.706) -19.20  (0.710) -7.53  (0.698)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.54
Confidence Interval (2-Sided) 95%
-13.49 to -9.59
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.68
Confidence Interval (2-Sided) 95%
-13.64 to -9.72
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Hide Description The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 149 147 152
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-30.73  (1.118) -30.16  (1.126) -16.69  (1.108)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.04
Confidence Interval (2-Sided) 95%
-17.13 to -10.94
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.48
Confidence Interval (2-Sided) 95%
-16.58 to -10.37
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.
Arm/Group Title Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 149 147 152
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-18.78  (0.804) -19.04  (0.810) -9.36  (0.797)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.42
Confidence Interval (2-Sided) 95%
-11.65 to -7.20
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.69
Confidence Interval (2-Sided) 95%
-11.92 to -7.46
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 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 179 176 178
Measure Type: Number
Unit of Measure: percentage of participants
87.7 84.1 63.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.09
Confidence Interval (2-Sided) 95%
2.38 to 7.03
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.03
Confidence Interval (2-Sided) 95%
1.82 to 5.03
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg
Hide Description Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6 , 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 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 179 176 178
Measure Type: Number
Unit of Measure: percentage of participants
92.7 90.3 78.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.72
Confidence Interval (2-Sided) 95%
1.90 to 7.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
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 2.70
Confidence Interval (2-Sided) 95%
1.46 to 5.00
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 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description:
Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
Overall Number of Participants Analyzed 179 176 178
Measure Type: Number
Unit of Measure: percentage of participants
84.9 80.7 58.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.00
Confidence Interval (2-Sided) 95%
2.41 to 6.64
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD, Chlorthalidone 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.96
Confidence Interval (2-Sided) 95%
1.83 to 4.79
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 and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Hide Arm/Group Description Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks. Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks. Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
All-Cause Mortality
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/184 (1.63%)   3/182 (1.65%)   1/181 (0.55%) 
Cardiac disorders       
Atrioventricular block complete  1  1/184 (0.54%)  0/182 (0.00%)  0/181 (0.00%) 
Cardiac failure  1  0/184 (0.00%)  0/182 (0.00%)  1/181 (0.55%) 
Cardiogenic shock  1  0/184 (0.00%)  0/182 (0.00%)  1/181 (0.55%) 
General disorders       
Chest discomfort  1  1/184 (0.54%)  0/182 (0.00%)  0/181 (0.00%) 
Infections and infestations       
Pneumonia  1  0/184 (0.00%)  0/182 (0.00%)  1/181 (0.55%) 
Urinary tract infection  1  0/184 (0.00%)  1/182 (0.55%)  0/181 (0.00%) 
Injury, poisoning and procedural complications       
Jaw fracture  1  0/184 (0.00%)  1/182 (0.55%)  0/181 (0.00%) 
Skin laceration  1  0/184 (0.00%)  1/182 (0.55%)  0/181 (0.00%) 
Investigations       
Heart rate decreased  1  1/184 (0.54%)  0/182 (0.00%)  0/181 (0.00%) 
Nervous system disorders       
Syncope  1  1/184 (0.54%)  1/182 (0.55%)  0/181 (0.00%) 
Lacunar infarction  1  0/184 (0.00%)  1/182 (0.55%)  0/181 (0.00%) 
Vascular disorders       
Hypertensive crisis  1  1/184 (0.54%)  0/182 (0.00%)  0/181 (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 and Chlorthalidone 25 mg QD Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD Chlorthalidone 25 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/184 (18.48%)   31/182 (17.03%)   29/181 (16.02%) 
Investigations       
Plasminogen activator inhibitor increased  1  12/184 (6.52%)  4/182 (2.20%)  3/181 (1.66%) 
Metabolism and nutrition disorders       
Hypokalaemia  1  2/184 (1.09%)  4/182 (2.20%)  11/181 (6.08%) 
Nervous system disorders       
Dizziness  1  16/184 (8.70%)  19/182 (10.44%)  6/181 (3.31%) 
Headache  1  8/184 (4.35%)  9/182 (4.95%)  13/181 (7.18%) 
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: NCT00591773     History of Changes
Other Study ID Numbers: 01-05-TL-491-009
U1111-1113-9040 ( Registry Identifier: WHO )
First Submitted: December 27, 2007
First Posted: January 11, 2008
Results First Submitted: March 24, 2011
Results First Posted: April 19, 2011
Last Update Posted: April 19, 2011