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Trial record 43 of 134 for:    OLMESARTAN

Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Moderate to Severe Hypertension.

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ClinicalTrials.gov Identifier: NCT01033071
Recruitment Status : Completed
First Posted : December 16, 2009
Results First Posted : February 7, 2012
Last Update Posted : February 7, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Essential Hypertension
Interventions Drug: Azilsartan medoxomil and chlorthalidone
Drug: Olmesartan medoxomil and hydrochlorothiazide
Enrollment 1071
Recruitment Details Participants enrolled at 130 investigative sites in Canada and the United States from 08 December 2009 to 04 November 2010.
Pre-assignment Details Participants with essential hypertension were enrolled in one of three, once-daily (QD) treatment groups.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Period Title: Overall Study
Started 355 352 364
Completed 300 275 317
Not Completed 55 77 47
Reason Not Completed
Adverse Event             28             51             26
Protocol Violation             0             2             1
Lost to Follow-up             4             5             5
Withdrawal by Subject             17             14             11
Lack of Efficacy             0             1             1
Other             6             4             3
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD Total
Hide Arm/Group Description

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 355 352 364 1071
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 355 participants 352 participants 364 participants 1071 participants
56.4  (10.49) 56.7  (10.07) 56.7  (10.86) 56.6  (10.47)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 355 participants 352 participants 364 participants 1071 participants
<45 years 46 33 46 125
Between 45 to 64 years 235 241 234 710
≥65 years 74 78 84 236
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 355 participants 352 participants 364 participants 1071 participants
Female
132
  37.2%
151
  42.9%
159
  43.7%
442
  41.3%
Male
223
  62.8%
201
  57.1%
205
  56.3%
629
  58.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 355 participants 352 participants 364 participants 1071 participants
Hispanic or Latino
28
   7.9%
36
  10.2%
34
   9.3%
98
   9.2%
Not Hispanic or Latino
248
  69.9%
241
  68.5%
251
  69.0%
740
  69.1%
Unknown or Not Reported
79
  22.3%
75
  21.3%
79
  21.7%
233
  21.8%
Race (NIH/OMB)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 355 participants 352 participants 364 participants 1071 participants
American Indian or Alaska Native 2 5 5 12
Asian 13 11 11 35
Native Hawaiian or Other Pacific Islander 0 1 2 3
Black or African American 80 80 80 240
White 261 258 267 786
More than one race 1 2 1 4
Unknown or Not Reported 0 0 0 0
[1]
Measure Description: A participant could have chosen more than 1 category for race; if so, they were included in each category indicated and were also included in the multiracial category.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 355 participants 352 participants 364 participants 1071 participants
United States 276 277 285 838
Canada 79 75 79 233
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 355 participants 352 participants 364 participants 1071 participants
92.34  (20.296) 91.47  (20.987) 90.83  (18.590) 91.54  (19.960)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 355 participants 352 participants 364 participants 1071 participants
171.2  (10.15) 169.3  (10.88) 169.4  (10.15) 170.0  (10.42)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 355 participants 352 participants 364 participants 1071 participants
31.4  (5.94) 31.9  (6.59) 31.6  (5.92) 31.6  (6.15)
Estimated glomerular filtration rate (eGFR)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 355 participants 352 participants 364 participants 1071 participants
≥0 to <30 0 0 1 1
≥30 to <60 26 29 25 80
≥60 to <90 224 220 246 690
≥90 105 103 91 299
Missing 0 0 1 1
[1]
Measure Description:

eGFR based on calculated creatinine clearance.

Categories:

Normal renal function (≥90 mL/min/1.73 m2); Mild renal impairment(60 to <90 mL/min/1.73 m2); Moderate renal impairment (30 to <60 mL/min/1.73 m2) Severe renal impairment (0 to <30 mL/min/1.73 m2)

1.Primary Outcome
Title Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.
Hide Description The change in sitting trough clinic systolic blood pressure measured at week 12 or final visit relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.
Time Frame Baseline and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 344 330 354
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-42.5  (0.81) -44.0  (0.83) -37.1  (0.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD, Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Comments Analysis of covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of “all treatment groups equal” first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.3
Confidence Interval 95%
-7.6 to -3.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD, Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Comments ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of “all treatment groups equal” first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.9
Confidence Interval (2-Sided) 95%
-9.2 to -4.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.
Hide Description The change in sitting trough clinic systolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.
Time Frame Baseline, Week 4 and Week 8.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 355 352 364
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Week 4 (n=343; n=330; n=352) -34.7  (0.77) -36.7  (0.79) -29.7  (0.76)
Week 8 (n=344; n=330; n=353) -39.1  (0.78) -39.4  (0.80) -33.5  (0.77)
3.Secondary Outcome
Title Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure.
Hide Description The change in sitting trough clinic diastolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average (arithmetic mean) of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.
Time Frame Baseline, Week 4, Week 8 and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 355 352 364
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Week 4 (n=343; n=330; n=352) -14.9  (0.46) -15.8  (0.47) -11.7  (0.45)
Week 8 (n=344; n=330; n=353) -17.0  (0.48) -17.7  (0.49) -13.9  (0.48)
Week 12 (n=344; n=330; n=354) -18.8  (0.47) -20.5  (0.48) -16.4  (0.46)
4.Secondary Outcome
Title Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
Hide Description The change in trough systolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Time Frame Baseline and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 232 214 238
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-32.9  (0.86) -34.9  (0.90) -25.9  (0.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD, Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Comments ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Tested at the 0.05 significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.0
Confidence Interval (2-Sided) 95%
-9.4 to -4.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD, Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Comments ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Tested at the 0.05 significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.0
Confidence Interval (2-Sided) 95%
-11.5 to -6.6
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
Hide Description The change in trough diastolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Time Frame Baseline and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 232 214 238
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-19.8  (0.55) -20.2  (0.57) -16.0  (0.54)
6.Secondary Outcome
Title Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
Hide Description The change in 24-hour mean systolic blood pressure measured at week 12 or final visit 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 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 232 214 238
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-33.9  (0.76) -36.3  (0.79) -27.5  (0.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD, Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Comments ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Tested at the 0.05 significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.4
Confidence Interval (2-Sided) 95%
-8.5 to -4.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD, Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Comments ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Tested at the 0.05 significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.8
Confidence Interval (2-Sided) 95%
-11.0 to -6.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
Hide Description The change in 24-hour mean diastolic blood pressure measured at week 12 or final visit 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 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 232 214 238
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-19.4  (0.45) -20.7  (0.46) -16.2  (0.44)
8.Secondary Outcome
Title Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
Hide Description The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 12 or final visit 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 (inclusive) and 10 PM (exclusive).
Time Frame Baseline and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 232 214 238
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-35.3  (0.80) -37.9  (0.84) -28.8  (0.79)
9.Secondary Outcome
Title Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
Hide Description The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 12 or final visit 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 (inclusive) and 10 PM (exclusive).
Time Frame Baseline and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 232 214 238
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-20.1  (0.48) -21.8  (0.50) -17.0  (0.47)
10.Secondary Outcome
Title Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
Hide Description The change in the mean nighttime (12am to 6am) systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive).
Time Frame Baseline and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 232 214 238
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-29.6  (0.78) -31.8  (0.81) -23.9  (0.77)
11.Secondary Outcome
Title Change From Baseline in Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
Hide Description The change in the mean nighttime (12am to 6am) diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive).
Time Frame Baseline and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 232 214 238
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-17.5  (0.48) -18.0  (0.50) -14.0  (0.48)
12.Secondary Outcome
Title Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.
Hide Description The change in the mean 12 hour systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements.
Time Frame Baseline and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 232 214 238
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-36.2  (0.86) -38.8  (0.89) -29.7  (0.85)
13.Secondary Outcome
Title Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.
Hide Description The change in the mean 12 hour diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements.
Time Frame Baseline and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 232 214 238
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-20.4  (0.51) -22.2  (0.53) -17.5  (0.50)
14.Secondary Outcome
Title Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.
Hide Description The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour.
Time Frame Baseline and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 355 352 364
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
0 to 1 Hour (n=232; n=212; n=237) -33.6  (0.96) -36.2  (1.00) -26.8  (0.95)
1 to 2 Hour (n=232; n=214; n=238) -33.4  (0.98) -36.4  (1.02) -27.5  (0.97)
2 to 3 Hour (n=232; n=214; n=238) -36.7  (1.02) -39.3  (1.06) -30.0  (1.00)
3 to 4 Hour (n=232; n=214; n=238) -36.6  (1.07) -40.3  (1.12) -29.6  (1.06)
4 to 5 Hour (n=232; n=214; n=238) -36.8  (1.07) -40.8  (1.11) -30.1  (1.06)
5 to 6 Hour (n=232; n=214; n=238) -37.2  (1.02) -41.2  (1.06) -31.5  (1.00)
6 to 7 Hour (n=232; n=214; n=238) -36.3  (1.04) -38.6  (1.08) -29.8  (1.02)
7 to 8 Hour (n=232; n=214; n=238) -37.2  (1.02) -38.5  (1.06) -29.7  (1.00)
8 to 9 Hour (n=232; n=214; n=238) -37.3  (1.02) -38.1  (1.06) -30.5  (1.01)
9 to 10 Hour (n=232; n=214; n=238) -36.9  (0.99) -38.0  (1.04) -30.8  (0.98)
10 to 11 Hour (n=232; n=214; n=238) -36.1  (1.02) -37.6  (1.06) -29.4  (1.01)
11 to 12 Hour (n=232; n=214; n=238) -35.2  (1.01) -38.2  (1.05) -29.3  (1.00)
12 to 13 Hour (n=232; n=214; n=238) -34.8  (1.05) -36.2  (1.09) -27.7  (1.04)
13 to 14 Hour (n=232; n=214; n=238) -34.1  (1.06) -35.3  (1.11) -26.4  (1.05)
14 to 15 Hour (n=232; n=214; n=238) -33.4  (1.06) -35.0  (1.10) -26.2  (1.04)
15 to 16 Hour (n=232; n=214; n=238) -30.9  (0.99) -32.9  (1.03) -25.3  (0.97)
16 to 17 Hour (n=232; n=214; n=238) -29.6  (0.94) -31.1  (0.98) -24.5  (0.93)
17 to 18 Hour (n=231; n=214; n=238) -28.5  (0.93) -30.8  (0.97) -23.1  (0.92)
18 to 19 Hour (n=232; n=214; n=238) -29.5  (0.90) -31.9  (0.94) -24.3  (0.89)
19 to 20 Hour (n=232; n=214; n=238) -29.7  (0.89) -32.5  (0.93) -23.5  (0.88)
20 to 21 Hour (n=232; n=214; n=238) -28.2  (0.94) -31.2  (0.98) -23.0  (0.92)
21 to 22 Hour (n=232; n=214; n=238) -30.6  (0.95) -32.8  (0.99) -24.6  (0.93)
22 to 23 Hour (n=232; n=214; n=238) -32.9  (0.94) -34.0  (0.98) -25.9  (0.92)
23 to 24 Hour (n=232; n=214; n=238) -33.1  (0.92) -35.8  (0.96) -26.1  (0.91)
15.Secondary Outcome
Title Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.
Hide Description The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour.
Time Frame Baseline and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 355 352 364
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
0 to 1 Hour (n=232; n=212; n=237) -18.2  (0.59) -20.4  (0.62) -15.2  (0.59)
1 to 2 Hour (n=232; n=214; n=238) -18.8  (0.65) -20.9  (0.67) -15.9  (0.64)
2 to 3 Hour (n=232; n=214; n=238) -21.2  (0.66) -23.4  (0.69) -17.7  (0.65)
3 to 4 Hour (n=232; n=214; n=238) -20.8  (0.69) -23.7  (0.72) -18.2  (0.68)
4 to 5 Hour (n=232; n=214; n=238) -21.7  (0.67) -23.7  (0.70) -17.9  (0.66)
5 to 6 Hour (n=232; n=214; n=238) -20.9  (0.67) -23.6  (0.70) -19.0  (0.66)
6 to 7 Hour (n=232; n=214; n=238) -20.8  (0.65) -22.0  (0.67) -18.0  (0.64)
7 to 8 Hour (n=232; n=214; n=238) -20.5  (0.66) -21.9  (0.69) -17.7  (0.65)
8 to 9 Hour (n=232; n=214; n=238) -20.7  (0.67) -21.5  (0.69) -17.9  (0.66)
9 to 10 Hour (n=232; n=214; n=238) -21.0  (0.66) -21.9  (0.68) -18.3  (0.65)
10 to 11 Hour (n=232; n=214; n=238) -19.7  (0.67) -20.7  (0.70) -16.7  (0.66)
11 to 12 Hour (n=232; n=214; n=238) -19.3  (0.69) -21.2  (0.72) -17.0  (0.68)
12 to 13 Hour (n=232; n=214; n=238) -19.2  (0.73) -20.3  (0.76) -16.0  (0.72)
13 to 14 Hour (n=232; n=214; n=238) -19.6  (0.72) -19.5  (0.75) -15.3  (0.71)
14 to 15 Hour (n=232; n=214; n=238) -18.9  (0.72) -19.7  (0.75) -15.4  (0.71)
15 to 16 Hour (n=232; n=214; n=238) -17.8  (0.65) -18.6  (0.68) -14.5  (0.65)
16 to 17 Hour (n=232; n=214; n=238) -17.2  (0.65) -16.9  (0.68) -13.9  (0.64)
17 to 18 Hour (n=231; n=214; n=238) -16.6  (0.64) -17.1  (0.66) -13.2  (0.63)
18 to 19 Hour (n=232; n=214; n=238) -17.4  (0.65) -18.1  (0.67) -14.3  (0.64)
19 to 20 Hour (n=232; n=214; n=238) -17.8  (0.60) -18.5  (0.63) -13.8  (0.60)
20 to 21 Hour (n=232; n=214; n=238) -16.7  (0.64) -18.4  (0.67) -13.9  (0.63)
21 to 22 Hour (n=232; n=214; n=238) -17.8  (0.66) -18.5  (0.69) -14.7  (0.65)
22 to 23 Hour (n=232; n=214; n=238) -19.5  (0.62) -19.6  (0.65) -15.6  (0.62)
23 to 24 Hour (n=232; n=214; n=238) -20.2  (0.60) -21.0  (0.62) -16.4  (0.59)
16.Secondary Outcome
Title Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline.
Hide Description Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, 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 non-missing values of the 3serial trough sitting systolic blood pressure measurements.
Time Frame Baseline, Week 4, Week 8 and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 355 352 364
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 (n=343; n=330; n=352) 87.8 90.0 79.8
Week 8 (n=344; n=330; n=353) 93.3 92.4 85.6
Week 12 (n=344; n=330; n=354) 93.0 94.2 89.3
17.Secondary Outcome
Title Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.
Hide Description Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, 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 non-missing values of the 3 serial trough sitting diastolic blood pressure measurements.
Time Frame Baseline, Week 4, Week 8 and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 355 352 364
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 (n=343; n=330; n=352) 89.2 89.7 85.2
Week 8 (n=344; n=330; n=353) 90.7 90.9 87.8
Week 12 (n=344; n=330; n=354) 94.5 95.8 91.5
18.Secondary Outcome
Title Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.
Hide Description Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at each week indicated, 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 non-missing values of the 3 serial trough sitting blood pressure measurements.
Time Frame Baseline, Week 4, Week 8 and Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
Arm/Group Title Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description:

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

Overall Number of Participants Analyzed 355 352 364
Measure Type: Number
Unit of Measure: percent of participants
Week 4 (n=343; n=330; n=352) 81.3 84.8 74.4
Week 8 (n=344; n=330; n=353) 88.1 87.3 81.0
Week 12 (n=344; n=330; n=354) 91.3 92.4 84.7
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 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Hide Arm/Group Description

Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.

Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.

Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.

Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.

All-Cause Mortality
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/355 (0.28%)   10/352 (2.84%)   8/364 (2.20%) 
Blood and lymphatic system disorders       
Anaemia  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
Cardiac disorders       
Arrhythmia  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
Atrial fibrillation  1  0/355 (0.00%)  0/352 (0.00%)  1/364 (0.27%) 
Cardiac failure congestive  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
Myocardial infarction  1  0/355 (0.00%)  0/352 (0.00%)  1/364 (0.27%) 
Ear and labyrinth disorders       
Vertigo  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
Gastrointestinal disorders       
Inguinal hernia  1  0/355 (0.00%)  0/352 (0.00%)  1/364 (0.27%) 
Pancreatitis acute  1  0/355 (0.00%)  0/352 (0.00%)  1/364 (0.27%) 
Vomiting  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
General disorders       
Non-cardiac chest pain  1  1/355 (0.28%)  1/352 (0.28%)  0/364 (0.00%) 
Infections and infestations       
Clostridial infection  1  0/355 (0.00%)  0/352 (0.00%)  1/364 (0.27%) 
Lobar pneumonia  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
Pneumonia  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
Sinusitis  1  0/355 (0.00%)  0/352 (0.00%)  1/364 (0.27%) 
Investigations       
Blood creatine phosphokinase increased  1  0/355 (0.00%)  0/352 (0.00%)  1/364 (0.27%) 
Metabolism and nutrition disorders       
Dehydration  1  0/355 (0.00%)  2/352 (0.57%)  0/364 (0.00%) 
Diabetes mellitus  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
Electrolyte imbalance  1  0/355 (0.00%)  0/352 (0.00%)  1/364 (0.27%) 
Hyperkalaemia  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
Hypomagnesaemia  1  0/355 (0.00%)  0/352 (0.00%)  1/364 (0.27%) 
Hyponatraemia  1  0/355 (0.00%)  0/352 (0.00%)  1/364 (0.27%) 
Nervous system disorders       
Syncope  1  0/355 (0.00%)  2/352 (0.57%)  0/364 (0.00%) 
Ischaemic stroke  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
Renal and urinary disorders       
Renal failure acute  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory failure  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
Vascular disorders       
Hypotension  1  0/355 (0.00%)  3/352 (0.85%)  0/364 (0.00%) 
Accelerated hypertension  1  0/355 (0.00%)  0/352 (0.00%)  1/364 (0.27%) 
Hypertension  1  0/355 (0.00%)  0/352 (0.00%)  1/364 (0.27%) 
Hypertensive emergency  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
Intermittent claudication  1  0/355 (0.00%)  1/352 (0.28%)  0/364 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   141/355 (39.72%)   144/352 (40.91%)   94/364 (25.82%) 
General disorders       
Fatigue  1  33/355 (9.30%)  14/352 (3.98%)  16/364 (4.40%) 
Investigations       
Blood creatinine increased  1  66/355 (18.59%)  78/352 (22.16%)  34/364 (9.34%) 
Blood uric acid increased  1  19/355 (5.35%)  17/352 (4.83%)  12/364 (3.30%) 
Nervous system disorders       
Dizziness  1  41/355 (11.55%)  58/352 (16.48%)  29/364 (7.97%) 
Headache  1  19/355 (5.35%)  13/352 (3.69%)  26/364 (7.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
EMail: clinicaltrialregistry@tpna.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01033071     History of Changes
Other Study ID Numbers: TAK-491CLD_303
U1111-1112-4298 ( Registry Identifier: WHO )
First Submitted: December 14, 2009
First Posted: December 16, 2009
Results First Submitted: January 4, 2012
Results First Posted: February 7, 2012
Last Update Posted: February 7, 2012