CompletedNCT00847626Updated Feb 7, 2012Results posted

Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Participants With Moderate to Severe Hypertension

A Phase 3 interventional study of Azilsartan medoxomil and chlorthalidone and Azilsartan medoxomil and chlorthalidone in Hypertension, sponsored by Takeda. Completed at 99 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-07.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,711
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil combined with chlorthalidone, once daily (QD), in participants with moderate to severe hypertension.

Read the detailed description

According to the World Health Organization (WHO), hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. Despite the availability of antihypertensive agents, hypertension remains inadequately controlled; only about one third of patients continue to maintain control successfully.

Although most antihypertensive agents are effective at the appropriate dose, the majority have side effects that limit their use. As a class, angiotensin II receptor blockers generally are considered more tolerable than other classes of antihypertensive agents. TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker that is being evaluated by Takeda to treat essential hypertension.

Treatments for essential hypertension commonly include use of a thiazide-like diuretic, either alone or as part of combination treatment.

This study is designed to compare the antihypertensive effect and the safety and tolerability of the azilsartan medoxomil plus chlorthalidone fixed-dose combination product (TAK 491CLD FDC) with azilsartan monotherapy and chlorthalidone monotherapy during 8 weeks of treatment.

Participants in this study will be randomized to receive one of 11 possible dosing combinations of azilsartan medoxomil , chlorthalidone and placebo over an 8 week period. The total duration of the study will be approximately 13 weeks. Participants will make 12 visits to the clinic. Each participant will also be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Conditions studied

Hypertension

Browse trials for

Hypertension 6,689

Keywords

Hypertensive
Blood Pressure, High
Vascular Disease
Cardiovascular Disease
Drug Therapy

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 1,711 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Is treated with antihypertensive therapy and has a post-washout mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg on the day prior to randomization, or the participant has not received antihypertensive treatment within 28 days prior to Screening and has a mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg at the Screening Visit and on the day prior to randomization.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Has clinical laboratory test results within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant.
Is willing to discontinue current antihypertensive medications on Day -21 or on Day -28 if on amlodipine or chlorthalidone.

Exclusion criteria

Exclusion Criteria:

Has a mean sitting clinic diastolic blood pressure greater than 119 mm Hg on the day prior to randomization.
Has a baseline 24-hour ambulatory blood pressure measurement reading of insufficient quality.
Has works a night (third) shift (defined as 11 PM [2300] to 7 AM [0700]).
Has an upper arm circumference less than 24 cm or greater than 42 cm.
Has is noncompliant with study medication during the placebo run-in period.
Has secondary hypertension of any etiology.
Has recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
Has clinically significant cardiac conduction defects.
Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
Has severe renal dysfunction or disease.
Has known or suspected unilateral or bilateral renal artery stenosis.
Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
Has poorly controlled type 1 or type 2 diabetes mellitus at Screening.
Has hypokalemia or hyperkalemia.
Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
Has any other known serious disease or condition that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow Has according to the protocol.
Has known hypersensitivity to angiotensin II receptor blockers, thiazide-type diuretics or other sulfonamide-derived compounds.
Has been randomized in a previous azilsartan medoxomil study.
Is currently participating in another investigational study or is receiving or has received any investigational compound within 30 days prior to Screening.
Has a history of drug abuse or a history of alcohol abuse within the past 2 years.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 1,711 participants (actual)

Study arms

Experimental
Azilsartan medoxomil 20 mg/chlorthalidone 12.5 mg QD
Drug: Azilsartan medoxomil and chlorthalidone
Experimental
Azilsartan medoxomil 20 mg/chlorthalidone 25 mg QD
Drug: Azilsartan medoxomil and chlorthalidone
Experimental
Azilsartan medoxomil 40 mg/chlorthalidone 12.5 mg QD
Drug: Azilsartan medoxomil and chlorthalidone
Experimental
Azilsartan medoxomil 40 mg/chlorthalidone 25 mg QD
Drug: Azilsartan medoxomil and chlorthalidone
Experimental
Azilsartan medoxomil 80 mg/chlorthalidone 12.5 mg QD
Drug: Azilsartan medoxomil and chlorthalidone
Experimental
Azilsartan medoxomil 80 mg/chlorthalidone 25 mg QD
Drug: Azilsartan medoxomil and chlorthalidone
Active comparator
Chlorthalidone 12.5 mg QD
Drug: Chlorthalidone
Active comparator
Chlorthalidone 25 mg QD
Drug: Chlorthalidone
Experimental
Azilsartan medoxomil 20 mg QD
Drug: Azilsartan medoxomil
Experimental
Azilsartan medoxomil 40 mg QD
Drug: Azilsartan medoxomil
Experimental
Azilsartan medoxomil 80 mg QD
Drug: Azilsartan medoxomil

Interventions

DrugAzilsartan medoxomil and chlorthalidone
Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
Also known as: TAK-491CLD
DrugAzilsartan medoxomil and chlorthalidone
Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
Also known as: TAK-491CLD
DrugAzilsartan medoxomil and chlorthalidone
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
Also known as: TAK-491CLD
DrugAzilsartan medoxomil and chlorthalidone
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
Also known as: TAK-491CLD
DrugAzilsartan medoxomil and chlorthalidone
Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
Also known as: TAK-491CLD
DrugAzilsartan medoxomil and chlorthalidone
Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
Also known as: TAK-491CLD
DrugChlorthalidone
Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
DrugChlorthalidone
Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
DrugAzilsartan medoxomil
Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks
Also known as: TAK-491CLD
DrugAzilsartan medoxomil
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks
Also known as: TAK-491CLD
DrugAzilsartan medoxomil
Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks
Also known as: TAK-491CLD

What researchers measure

Primary outcomes

Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pooled Analysis)
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Time frame: Baseline and Week 8.
Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pairwise Analysis)
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Time frame: Baseline and Week 8.

Secondary outcomes

Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 serial trough sitting systolic blood pressure measurements.
Time frame: Baseline and Week 8
Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pooled Analysis)
The change in trough systolic blood pressure in black subjects measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Time frame: Baseline and Week 8.
Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pairwise Analysis)
The change in trough systolic blood pressure in black participants as measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Time frame: Baseline and Week 8.
Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure
The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough clinic sitting diastolic blood pressure measurements.
Time frame: Baseline and Week 8.
Change From Baseline to Week 8 in the Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing), as Measured by Ambulatory Blood Pressure Monitoring.
The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Time frame: Baseline and Week 8.
Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
The change in 24-hour mean systolic blood pressure measured at final visit or week 8 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 8.
Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
The change in 24-hour mean diastolic blood pressure measured at final visit or week 8 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 8.
Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
The change in daytime (6am to 10pm) mean systolic blood pressure measured at final visit or week 8 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 8.
Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
The change in daytime (6am to 10pm) mean diastolic blood pressure measured at final visit or week 8 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 8.
Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
The change in nighttime (12am to 6am) mean systolic blood pressure measured at final visit or week 8 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 8.
Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
The change in nighttime (12am to 6am) mean diastolic blood pressure measured at final visit or week 8 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 8.
Change From Baseline to Week 8 in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.
The change in the 12-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Time frame: Baseline and Week 8
Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.
The change in the 12-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Time frame: Baseline and Week 8.
Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response at Week 8, as Defined by Clinic Systolic Blood Pressure <140 mm Hg and/or a Reduction of ≥20 mm Hg From Baseline.
Percentage of participants who achieve a clinic systolic blood pressure response measured at week 8, 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 average of the 3 serial trough sitting clinic systolic blood pressure measurements.
Time frame: Baseline and Week 8
Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response at Week 8, Defined as Clinic Diastolic Blood Pressure <90 mm Hg and/or a Reduction of ≥10 mm Hg From Baseline.
Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 8, 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 average of the 3 serial trough sitting clinic diastolic blood pressure measurements.
Time frame: Baseline and Week 8.
Percentage of Participants Who Achieve Both a Clinic Systolic and Diastolic Blood Pressure Response at Week 8.
Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at week 8, defined as systolic blood pressure less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg AND diastolic blood pressure less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg . Systolic/diastolic blood pressure is based on the average of the 3 serial trough clinic sitting systolic/diastolic blood pressure measurements.
Time frame: Baseline and Week 8.

Results

Posted Feb 7, 2012

Participant flow

Participants enrolled at 175 investigative sites in Austria, Chile, Germany, Guatemala, Mexico, Netherlands, Peru, Poland, Russian Federation and the United States from 29 January 2009 to 10 July 2010.

Participant flow — Overall Study
Milestone	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Started	156	154	147	156	153	162	157	160	155	153	162
Completed	135	131	131	125	125	125	135	141	141	139	142
Not completed	21	23	16	31	28	37	22	19	14	14	20
Withdrew: Adverse event	10	10	6	19	11	22	4	6	3	6	6
Withdrew: Protocol violation	2	1	2	1	1	1	1	1	0	1	1
Withdrew: Lost to follow-up	0	1	1	1	0	3	1	3	1	0	1
Withdrew: Withdrawal by subject	5	5	3	8	12	9	8	4	4	5	2
Withdrew: Lack of efficacy	3	1	0	1	2	0	6	2	5	1	7
Withdrew: Other	1	5	4	1	2	2	2	3	1	1	3

Outcome measures

PrimaryChange From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pooled Analysis)

The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.

Time frame:: Baseline and Week 8.
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pooled Analysis)
mmHg	Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pooled Analysis)	-28.9 ± 0.89	-15.9 ± 1.16	-15.1 ± 1.19

Statistical analysis

Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD vs Chlorthalidone 25 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (net): -13.0 · 95% CI -15.8 to -9.5
Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD vs Azilsartan Medoxomil 80 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -13.8 · 95% CI -16.7 to -10.9

SecondaryChange From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure

The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 serial trough sitting systolic blood pressure measurements.

Time frame:: Baseline and Week 8
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure
mmHg	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure	-33.8 ± 1.26	-37.0 ± 1.26	-36.8 ± 1.30	-39.5 ± 1.25	-36.9 ± 1.27	-40.1 ± 1.24	-21.1 ± 1.25	-27.1 ± 1.25	-19.8 ± 1.26	-23.3 ± 1.27	-24.2 ± 1.23

Statistical analysis

Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD vs Chlorthalidone 12.5 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -12.7 · 95% CI -16.2 to -9.2
Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD vs Chlorthalidone 25 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -9.9 · 95% CI -13.4 to -6.4
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD vs Chlorthalidone 12.5 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -15.7 · 95% CI -19.2 to -12.1
Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD vs Chlorthalidone 25 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -12.4 · 95% CI -15.8 to -8.9
Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD vs Chlorthalidone 12.5 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -15.8 · 95% CI -19.3 to -12.3
Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD vs Chlorthalidone 25 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -13.0 · 95% CI -16.5 to -9.5
Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD vs Azilsartan Medoxomil 20 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -14.0 · 95% CI -17.5 to -10.5
Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD vs Azilsartan Medoxomil 20 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -17.2 · 95% CI -20.6 to -13.7
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD vs Azilsartan Medoxomil 40 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -13.5 · 95% CI -17.0 to -9.9
Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD vs Azilsartan Medoxomil 40 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -16.2 · 95% CI -19.7 to -12.7
Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD vs Azilsartan Medoxomil 80 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -12.8 · 95% CI -16.3 to -9.3
Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD vs Azilsartan Medoxomil 80 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -16.0 · 95% CI -19.4 to -12.6

SecondaryChange From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pooled Analysis)

The change in trough systolic blood pressure in black subjects measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.

Time frame:: Baseline and Week 8.
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pooled Analysis)
mmHg	Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pooled Analysis)	-28.2 ± 2.49	-23.4 ± 3.36	-9.9 ± 2.97

Statistical analysis

Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD vs Azilsartan Medoxomil 80 mg QD · ANCOVA · p = 0.255 (Tested at 5% significance level.) · Mean difference (final values): -4.8 · 95% CI -13.0 to 3.5
Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD vs Azilsartan Medoxomil 80 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -18.2 · 95% CI -25.9 to -10.6

SecondaryChange From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pairwise Analysis)

The change in trough systolic blood pressure in black participants as measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.

Time frame:: Baseline and Week 8.
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pairwise Analysis)
mmHg	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pairwise Analysis)	-27.2 ± 3.21	-25.4 ± 3.36	-21.5 ± 3.21	-31.9 ± 3.61	-24.8 ± 3.71	-24.4 ± 3.43	-12.2 ± 3.22	-23.4 ± 3.36	-10.7 ± 3.10	-11.0 ± 3.04	-9.9 ± 2.97

SecondaryChange From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure

The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough clinic sitting diastolic blood pressure measurements.

Time frame:: Baseline and Week 8.
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure
mmHg	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure	-14.4 ± 0.72	-15.5 ± 0.72	-15.6 ± 0.74	-17.0 ± 0.72	-16.9 ± 0.73	-18.5 ± 0.71	-7.4 ± 0.72	-9.2 ± 0.72	-6.7 ± 0.72	-9.2 ± 0.73	-9.9 ± 0.70

SecondaryChange From Baseline to Week 8 in the Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing), as Measured by Ambulatory Blood Pressure Monitoring.

The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.

Time frame:: Baseline and Week 8.
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in the Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing), as Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in the Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing), as Measured by Ambulatory Blood Pressure Monitoring.	-13.3 ± 0.80	-15.0 ± 0.83	-13.5 ± 0.83	-17.3 ± 0.85	-16.5 ± 0.86	-16.1 ± 0.85	-6.5 ± 0.79	-7.5 ± 0.78	-7.9 ± 0.80	-7.3 ± 0.79	-8.9 ± 0.80

SecondaryChange From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring

The change in 24-hour mean systolic blood pressure measured at final visit or week 8 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 8.
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
mmHg	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring	-24.0 ± 0.97	-26.7 ± 1.01	-26.1 ± 1.01	-30.4 ± 1.03	-27.9 ± 1.04	-28.1 ± 1.03	-10.9 ± 0.96	-14.7 ± 0.95	-11.7 ± 0.97	-12.6 ± 0.96	-15.3 ± 0.97

SecondaryChange From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring

The change in 24-hour mean diastolic blood pressure measured at final visit or week 8 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 8.
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
mmHg	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring	-13.5 ± 0.60	-15.0 ± 0.62	-14.9 ± 0.63	-17.3 ± 0.64	-16.5 ± 0.65	-15.9 ± 0.64	-5.6 ± 0.59	-6.7 ± 0.59	-6.8 ± 0.60	-7.6 ± 0.59	-8.8 ± 0.60

SecondaryChange From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.

The change in daytime (6am to 10pm) mean systolic blood pressure measured at final visit or week 8 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 8.
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.	-24.4 ± 1.01	-27.7 ± 1.05	-26.7 ± 1.06	-31.2 ± 1.07	-28.4 ± 1.09	-28.5 ± 1.07	-10.8 ± 1.00	-14.7 ± 0.99	-11.7 ± 1.01	-12.8 ± 1.00	-15.7 ± 1.01

SecondaryChange From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.

The change in daytime (6am to 10pm) mean diastolic blood pressure measured at final visit or week 8 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 8.
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.	-13.7 ± 0.64	-15.6 ± 0.66	-15.1 ± 0.66	-17.6 ± 0.67	-16.8 ± 0.69	-16.2 ± 0.67	-5.6 ± 0.63	-6.5 ± 0.62	-6.8 ± 0.64	-7.7 ± 0.63	-9.1 ± 0.64

SecondaryChange From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.

The change in nighttime (12am to 6am) mean systolic blood pressure measured at final visit or week 8 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 8.
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.	-22.5 ± 1.09	-24.0 ± 1.13	-24.3 ± 1.14	-28.1 ± 1.15	-26.5 ± 1.17	-26.3 ± 1.15	-11.3 ± 1.08	-14.4 ± 1.06	-11.8 ± 1.09	-11.8 ± 1.08	-14.2 ± 1.09

SecondaryChange From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.

The change in nighttime (12am to 6am) mean diastolic blood pressure measured at final visit or week 8 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 8.
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.	-12.8 ± 0.71	-13.5 ± 0.73	-14.4 ± 0.74	-16.2 ± 0.75	-15.8 ± 0.76	-14.9 ± 0.75	-6.0 ± 0.70	-7.1 ± 0.69	-6.9 ± 0.70	-7.5 ± 0.69	-8.0 ± 0.71

SecondaryChange From Baseline to Week 8 in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.

The change in the 12-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.

Time frame:: Baseline and Week 8
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.	-24.6 ± 1.07	-28.0 ± 1.11	-27.1 ± 1.12	-31.7 ± 1.13	-28.5 ± 1.15	-28.7 ± 1.13	-10.4 ± 1.06	-14.5 ± 1.04	-11.8 ± 1.07	-12.7 ± 1.05	-15.8 ± 1.07

SecondaryChange From Baseline to Week 8 in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.

The change in the 12-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.

Time frame:: Baseline and Week 8.
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.
mmHg	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.	-13.6 ± 0.68	-15.6 ± 0.71	-15.4 ± 0.71	-17.8 ± 0.72	-16.8 ± 0.73	-16.2 ± 0.72	-5.3 ± 0.67	-6.3 ± 0.66	-6.8 ± 0.68	-7.6 ± 0.67	-9.2 ± 0.68

SecondaryPercentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response at Week 8, as Defined by Clinic Systolic Blood Pressure <140 mm Hg and/or a Reduction of ≥20 mm Hg From Baseline.

Percentage of participants who achieve a clinic systolic blood pressure response measured at week 8, 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 average of the 3 serial trough sitting clinic systolic blood pressure measurements.

Time frame:: Baseline and Week 8
Reported as:: Number · percentage of participants

Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response at Week 8, as Defined by Clinic Systolic Blood Pressure <140 mm Hg and/or a Reduction of ≥20 mm Hg From Baseline.
percentage of participants	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response at Week 8, as Defined by Clinic Systolic Blood Pressure <140 mm Hg and/or a Reduction of ≥20 mm Hg From Baseline.	86.4	88.9	90.3	93.5	86.8	94.9	56.1	76.9	53.5	64.5	66.7

PrimaryChange From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pairwise Analysis)

Time frame:: Baseline and Week 8.
Reported as:: Least squares mean · mmHg

Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pairwise Analysis)
mmHg	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pairwise Analysis)	-22.9 ± 1.19	-26.3 ± 1.24	-24.4 ± 1.24	-29.8 ± 1.26	-26.3 ± 1.28	-28.0 ± 1.26	-12.7 ± 1.18	-15.9 ± 1.16	-12.1 ± 1.19	-12.8 ± 1.17	-15.1 ± 1.19

Statistical analysis

Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD vs Chlorthalidone 12.5 mg QD · ANCOVA · p = < 0.001 (Tested at 5% significance level.) · Mean difference (final values): -10.3 · 95% CI -13.6 to -7.0
Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD vs Chlorthalidone 25 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -10.4 · 95% CI -13.7 to -7.0
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD vs Chlorthalidone 12.5 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -11.8 · 95% CI -15.1 to -8.4
Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD vs Chlorthalidone 25 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -13.9 · 95% CI -17.3 to -10.6
Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD vs Chlorthalidone 12.5 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -13.7 · 95% CI -17.1 to -10.3
Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD vs Chlorthalidone 25 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -12.0 · 95% CI -15.4 to -8.7
Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD vs Azilsartan Medoxomil 20 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -10.9 · 95% CI -14.2 to -7.6
Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD vs Azilsartan Medoxomil 20 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -14.2 · 95% CI -17.6 to -10.9
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD vs Azilsartan Medoxomil 40 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -11.6 · 95% CI -15.0 to -8.3
Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD vs Azilsartan Medoxomil 40 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -17.0 · 95% CI -20.4 to -13.6
Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD vs Azilsartan Medoxomil 80 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -11.2 · 95% CI -14.7 to -7.8
Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD vs Azilsartan Medoxomil 80 mg QD · ANCOVA · p = <0.001 (Tested at 5% significance level.) · Mean difference (final values): -12.8 · 95% CI -16.2 to -9.4

SecondaryPercentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response at Week 8, Defined as Clinic Diastolic Blood Pressure <90 mm Hg and/or a Reduction of ≥10 mm Hg From Baseline.

Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 8, 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 average of the 3 serial trough sitting clinic diastolic blood pressure measurements.

Time frame:: Baseline and Week 8.
Reported as:: Number · percentage of participants

Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response at Week 8, Defined as Clinic Diastolic Blood Pressure <90 mm Hg and/or a Reduction of ≥10 mm Hg From Baseline.
percentage of participants	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response at Week 8, Defined as Clinic Diastolic Blood Pressure <90 mm Hg and/or a Reduction of ≥10 mm Hg From Baseline.	89.6	89.5	87.6	94.8	90.1	96.8	63.9	78.8	60.6	71.1	74.7

SecondaryPercentage of Participants Who Achieve Both a Clinic Systolic and Diastolic Blood Pressure Response at Week 8.

Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at week 8, defined as systolic blood pressure less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg AND diastolic blood pressure less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg . Systolic/diastolic blood pressure is based on the average of the 3 serial trough clinic sitting systolic/diastolic blood pressure measurements.

Time frame:: Baseline and Week 8.
Reported as:: Number · percentage of participants

Percentage of Participants Who Achieve Both a Clinic Systolic and Diastolic Blood Pressure Response at Week 8.
percentage of participants	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Percentage of Participants Who Achieve Both a Clinic Systolic and Diastolic Blood Pressure Response at Week 8.	83.1	84.3	84.8	91.0	82.8	93.0	45.8	67.9	39.4	55.3	62.3

Adverse events

Collected over Treatment-emergent adverse events are adverse events that started on or 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	—	3/156 (1.9%)	52/156 (33.3%)
Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	—	0/154 (0%)	55/154 (35.7%)
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	—	1/146 (0.7%)	40/146 (27.4%)
Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	—	2/156 (1.3%)	74/156 (47.4%)
Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	—	2/153 (1.3%)	52/153 (34%)
Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	—	2/161 (1.2%)	67/161 (41.6%)
Chlorthalidone 12.5 mg QD	—	0/156 (0%)	51/156 (32.7%)
Chlorthalidone 25 mg QD	—	2/160 (1.3%)	53/160 (33.1%)
Azilsartan Medoxomil 20 mg QD	—	2/155 (1.3%)	25/155 (16.1%)
Azilsartan Medoxomil 40 mg QD	—	2/153 (1.3%)	36/153 (23.5%)
Azilsartan Medoxomil 80 mg QD	—	3/162 (1.9%)	32/162 (19.8%)

Most frequent serious events

Showing 10 of 29

Most frequent serious events
Event	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Metabolic encephalopathyNervous system disorders	0/156	0/154	1/146	0/156	0/153	0/161	0/156	0/160	0/155	0/153	0/162
Myocardial ischaemiaCardiac disorders	0/156	0/154	0/146	0/156	0/153	0/161	0/156	0/160	1/155	1/153	0/162
Supraventricular tachycardiaCardiac disorders	0/156	0/154	0/146	0/156	0/153	0/161	0/156	0/160	0/155	1/153	0/162
Non-cardiac chest painGastrointestinal disorders	0/156	0/154	0/146	0/156	0/153	0/161	0/156	0/160	0/155	1/153	0/162
Blood urea increasedInvestigations	1/156	0/154	0/146	0/156	1/153	0/161	0/156	0/160	0/155	0/153	0/162
Blood creatinine increasedInvestigations	0/156	0/154	0/146	0/156	1/153	0/161	0/156	0/160	0/155	0/153	0/162
Blood uric acid increasedInvestigations	0/156	0/154	0/146	0/156	1/153	0/161	0/156	0/160	0/155	0/153	0/162
DyspnoeaRespiratory, thoracic and mediastinal disorders	0/156	0/154	0/146	0/156	1/153	0/161	0/156	0/160	0/155	0/153	0/162
Bipolar disorderPsychiatric disorders	0/156	0/154	0/146	0/156	0/153	0/161	0/156	0/160	1/155	0/153	0/162
Suicidal ideationPsychiatric disorders	0/156	0/154	0/146	0/156	0/153	0/161	0/156	0/160	1/155	0/153	0/162

Most frequent other events

Most frequent other events
Event	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD
Blood creatinine increasedInvestigations	15/156	19/154	17/146	29/156	18/153	32/161	5/156	9/160	4/155	5/153	6/162
DizzinessNervous system disorders	12/156	17/154	20/146	21/156	19/153	19/161	6/156	5/160	2/155	7/153	6/162
HeadacheNervous system disorders	8/156	12/154	1/146	9/156	11/153	11/161	19/156	17/160	13/155	11/153	12/162
HypokalaemiaMetabolism and nutrition disorders	3/156	2/154	0/146	5/156	0/153	2/161	4/156	19/160	0/155	1/153	0/162
Blood creatine phosphokinase increasedInvestigations	3/156	4/154	3/146	10/156	3/153	3/161	6/156	7/160	6/155	7/153	6/162
HyperuricaemiaMetabolism and nutrition disorders	2/156	6/154	4/146	3/156	3/153	10/161	3/156	3/160	0/155	0/153	0/162
Blood uric acid increasedInvestigations	3/156	9/154	6/146	7/156	9/153	3/161	6/156	5/160	1/155	2/153	1/162
Blood urea increasedInvestigations	1/156	6/154	4/146	8/156	6/153	9/161	0/156	4/160	0/155	0/153	1/162
NasopharyngitisInfections and infestations	8/156	5/154	2/146	7/156	2/153	3/161	6/156	4/160	2/155	7/153	2/162
Muscle spasmsMusculoskeletal and connective tissue disorders	8/156	2/154	0/146	6/156	2/153	4/161	2/156	0/160	2/155	0/153	2/162

Baseline characteristics

Age Continuous
Age Continuous(years)	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Total
Mean	58.2 ± 10.57	57.4 ± 11.13	56.2 ± 10.50	57.4 ± 11.07	55.8 ± 11.22	57.6 ± 11.04	57.3 ± 11.30	56.2 ± 10.04	57.3 ± 11.04	57.8 ± 10.28	57.3 ± 10.87	57.2 ± 10.82

Age, Customized
Age, Customized(participants)	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Total
<45 years	15	16	17	21	25	19	21	18	18	17	16	203
Between 45 to 64 years	98	97	100	93	90	104	97	108	97	98	107	1089
≥65 years	43	41	30	42	38	39	39	33	40	38	39	422

Sex: Female, Male
Sex: Female, Male(Participants)	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Total
Female	86	77	76	85	82	100	74	90	87	68	84	909
Male	70	77	71	71	71	62	83	69	68	85	78	805

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Total
Hispanic or Latino	10	19	11	15	19	15	17	19	20	17	15	177
Not Hispanic or Latino	90	75	76	85	71	87	84	86	77	80	86	897
Unknown or Not Reported	56	60	60	56	63	60	56	54	58	56	61	640

Race (NIH/OMB)
Race (NIH/OMB)(participants)	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Total
American Indian or Alaska Native	9	13	13	13	12	16	14	14	11	13	14	142
Asian	4	3	4	4	2	3	1	7	1	1	4	34
Native Hawaiian or Other Pacific Islander	0	1	0	0	0	0	1	0	0	0	0	2
Black or African American	34	28	29	30	26	34	31	29	31	35	35	342
White	111	112	102	111	114	109	111	111	113	105	111	1210
More than one race	2	2	1	2	1	0	1	2	1	1	2	15
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Total
Austria	1	0	0	0	1	0	0	0	0	0	0	2
Chile	3	3	3	2	2	3	2	1	2	3	2	26
Germany	4	6	6	5	6	5	4	5	3	4	5	53
Guatemala	8	8	9	10	10	8	8	9	8	9	9	96
Mexico	10	11	11	9	12	11	11	8	13	11	12	119
Netherlands	6	7	6	5	7	5	6	6	6	6	7	67
Peru	11	12	13	12	12	14	12	11	13	12	12	134
Poland	8	8	7	8	8	8	7	8	8	7	8	85
Russian Federation	5	5	5	5	5	6	6	6	5	4	6	58
United States	100	94	87	100	90	102	101	105	97	97	101	1074

Height
Height(cm)	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Total
Mean	166.3 ± 11.71	166.6 ± 10.85	167.1 ± 11.44	166.8 ± 11.64	166.6 ± 10.81	165.4 ± 10.79	168.3 ± 11.07	166.1 ± 11.36	166.4 ± 10.65	167.7 ± 12.27	167.1 ± 11.85	166.8 ± 11.32

Weight
Weight(kg)	Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD	Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD	Chlorthalidone 12.5 mg QD	Chlorthalidone 25 mg QD	Azilsartan Medoxomil 20 mg QD	Azilsartan Medoxomil 40 mg QD	Azilsartan Medoxomil 80 mg QD	Total
Mean	89.85 ± 22.076	86.06 ± 18.056	89.28 ± 21.484	90.16 ± 21.949	87.31 ± 19.209	86.44 ± 20.412	89.12 ± 21.049	86.70 ± 20.270	87.27 ± 18.934	87.54 ± 19.019	86.27 ± 20.354	87.80 ± 20.289

3 further baseline measures are reported on the registry.

Study locations

99 sites

Birmingham, Alabama, United States
Columbiana, Alabama, United States
Tuscaloosa, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Buena Park, California, United States
Carmichael, California, United States
Costa Mesa, California, United States
Irvine, California, United States
Palm Springs, California, United States
Riverside, California, United States
Sacramento, California, United States
San Diego, California, United States
Vista, California, United States
Walnut Creek, California, United States
Middletown, Delaware, United States
Bradenton, Florida, United States
Deerfield Beach, Florida, United States
Fort Lauderdale, Florida, United States
Hallandale Beach, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Longwood, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Ormond Beach, Florida, United States
St Petersburg, Florida, United States
Atlanta, Georgia, United States
Buffalo Grove, Illinois, United States
Libertyville, Illinois, United States
Melrose Park, Illinois, United States
Fishers, Indiana, United States
Indianapolis, Indiana, United States
Erlanger, Kentucky, United States
Madisonville, Kentucky, United States
Paducah, Kentucky, United States
Rockville, Maryland, United States
Ann Arbor, Michigan, United States
Chesterfield, Michigan, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Henderson, Nevada, United States
Brick, New Jersey, United States
Margate, New Jersey, United States
Albuquerque, New Mexico, United States
Endwell, New York, United States
Cary, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Lyndhurst, Ohio, United States
Willoughby Hills, Ohio, United States
Oklahoma City, Oklahoma, United States
Ashland, Oregon, United States
Altoona, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Feasterville, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Warminster, Pennsylvania, United States
Charleston, South Carolina, United States
Florence, South Carolina, United States
Murrells Inlet, South Carolina, United States
Simpsonville, South Carolina, United States
Spartanburg, South Carolina, United States
Clarksville, Tennessee, United States
New Tazewell, Tennessee, United States
Austin, Texas, United States
Bellaire, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
McKinney, Texas, United States
Richardson, Texas, United States
San Antonio, Texas, United States
Magna, Utah, United States
West Jordan, Utah, United States
Arlington, Virginia, United States
Virginia Beach, Virginia, United States
Oregon, Wisconsin, United States
Santiago, Chile
Temuco, Chile
Aguascalientes, Mexico
Merida, Mexico
Mexico DF, Mexico
Bellavista, Peru
Chiclayo, Peru
Jesus Maria, Peru
Miraflores, Peru
San Borja, Peru
San Martin de Porres, Peru
Trujillo, Peru
Umacollo, Peru
Moscow, Russian Federation
St. Petersburg, Russian Federation

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 7, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00847626
Lead sponsor: Takeda
Responsible party: Sponsor
First posted: Feb 19, 2009
Start date: Jan 2009
Primary completion: May 2010
Completion: Jul 2010
Results posted: Feb 7, 2012
Last update: Feb 7, 2012

Study contacts

Executive Medical Director

study director · Takeda

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Participants With Moderate to Severe Hypertension

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