Back to resultsEfficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Azilsartan medoxomil
Azilsartan medoxomil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Blood pressure, blood pressure monitoring ambulatory, Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- The participant has essential hypertension (defined as sitting trough clinic systolic blood pressure between 150 and 180 mm Hg, inclusive at Day -1) and 24-hour mean systolic blood pressure 130-170 mm Hg, inclusive, at Day 1.
- 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.
- Clinical laboratory evaluations within the reference range for the testing laboratory unless the results are deemed not clinically significant for inclusion into this study by the investigator.
- Willing to discontinue current antihypertensive medication.
Exclusion Criteria:
- Has sitting trough clinic diastolic blood pressure greater than 114 mm Hg.
- Baseline 24 hour ambulatory blood pressure monitor reading of insufficient quality.
- Hypersensitive to angiotensin II receptor blockers.
- History of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
- Clinically significant cardiac conduction defects.
- Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
- Secondary hypertension of any etiology.
- Non-compliant with study medication during run-in period.
- Severe renal dysfunction or disease (based on calculated creatinine clearance less than 30 mL/min/1.73 m2) at Screening.
- Known or suspected unilateral or bilateral renal artery stenosis.
- History of drug abuse or a history of alcohol abuse within the past 2 years.
- Previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
- Type 1 or poorly controlled type 2 diabetes mellitus.
- Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
- Hyperkalemia.
- Upper arm circumference less than 24 cm or greater than 42 cm.
- Works night (3rd) shift.
- Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
- Any other serious disease or condition at Screening (or Randomization) that would compromise participant safety, might affect life expectancy, or make it difficult to successfully manage and follow the participant according to the protocol.
- Randomized in a previous azilsartan medoxomil study.
- Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Azilsartan Medoxomil 40 mg QD
Azilsartan Medoxomil 80 mg QD
Placebo QD
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Secondary Outcome Measures
Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure
The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.
Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline.
Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg
Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg
Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response
Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00591253
Brief Title
Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension
Official Title
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 in Black Subjects With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of azilsartan medoxomil compared to placebo, once daily (QD), in African-American participants with essential hypertension.
Detailed Description
Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, 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. Despite the availability of antihypertensive treatments, hypertension remains inadequately controlled; only about one third of patients continue to maintain control successfully.
A major component of blood pressure regulation is the renin-angiotensin-aldosterone system, a system of hormone-mediated feedback interactions that results in the relaxation or constriction of blood vessels in response to various stimuli. Angiotensin II, a polypeptide hormone, is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme as part of the renin-angiotensin-aldosterone system. Angiotensin II is the principal pressor agent of the renin-angiotensin-aldosterone system with a myriad of effects on the cardiovascular system and on electrolyte homeostasis.
In the United States, a disproportionate number of African-Americans have hypertension compared to age-matched non-Hispanic Caucasians and Mexican Americans. Earlier onset and greater severity of hypertension in African-Americans contribute to greater target organ damage and may be a factor in shorter life expectancy in this population compared to Caucasian-Americans. Although genetic factors have been invoked to explain these racial differences, environmental factors probably play a more important role. Improved management of hypertension through both lifestyle intervention and pharmacotherapy, including combination therapy, are necessary to achieve target blood pressure in African Americans.
Takeda Global Research & Development Center, Inc. is developing TAK-491 (azilsartan medoxomil) to treat patients with essential hypertension. Azilsartan medoxomil is a prodrug that is hydrolyzed to the active moiety, TAK-536 (azilsartan), which is a selective antagonist of the angiotensin II type 1 receptor subtype.
This study is being conducted to evaluate the effectiveness and safety of oral azilsartan medoxomil compared with placebo in African-American participants with essential hypertension. Participation in this study is anticipated to be approximately 10 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Blood pressure, blood pressure monitoring ambulatory, Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
413 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azilsartan Medoxomil 40 mg QD
Arm Type
Experimental
Arm Title
Azilsartan Medoxomil 80 mg QD
Arm Type
Experimental
Arm Title
Placebo QD
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Azilsartan medoxomil
Other Intervention Name(s)
TAK-491, Edarbi
Intervention Description
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Azilsartan medoxomil
Other Intervention Name(s)
TAK-491, Edarbi
Intervention Description
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Description
The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Time Frame
Baseline and Week 6.
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure
Description
The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.
Time Frame
Baseline and Week 6.
Title
Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Description
The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Time Frame
Baseline and Week 6.
Title
Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
Description
The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline.
Time Frame
Baseline and Week 6.
Title
Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Description
The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Time Frame
Baseline and Week 6.
Title
Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Description
The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Time Frame
Baseline and Week 6.
Title
Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Description
The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Time Frame
Baseline and Week 6.
Title
Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Description
The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Time Frame
Baseline and Week 6.
Title
Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Description
The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Time Frame
Baseline and Week 6.
Title
Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Description
The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Time Frame
Baseline and Week 6.
Title
Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Description
The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Time Frame
Baseline and Week 6.
Title
Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Description
The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Time Frame
Baseline and Week 6.
Title
Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg
Description
Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Time Frame
Baseline and Week 6.
Title
Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg
Description
Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
Time Frame
Baseline and Week 6.
Title
Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response
Description
Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.
Time Frame
Baseline and Week 6.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participant has essential hypertension (defined as sitting trough clinic systolic blood pressure between 150 and 180 mm Hg, inclusive at Day -1) and 24-hour mean systolic blood pressure 130-170 mm Hg, inclusive, at Day 1.
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.
Clinical laboratory evaluations within the reference range for the testing laboratory unless the results are deemed not clinically significant for inclusion into this study by the investigator.
Willing to discontinue current antihypertensive medication.
Exclusion Criteria:
Has sitting trough clinic diastolic blood pressure greater than 114 mm Hg.
Baseline 24 hour ambulatory blood pressure monitor reading of insufficient quality.
Hypersensitive to angiotensin II receptor blockers.
History of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
Clinically significant cardiac conduction defects.
Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
Secondary hypertension of any etiology.
Non-compliant with study medication during run-in period.
Severe renal dysfunction or disease (based on calculated creatinine clearance less than 30 mL/min/1.73 m2) at Screening.
Known or suspected unilateral or bilateral renal artery stenosis.
History of drug abuse or a history of alcohol abuse within the past 2 years.
Previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
Type 1 or poorly controlled type 2 diabetes mellitus.
Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
Hyperkalemia.
Upper arm circumference less than 24 cm or greater than 42 cm.
Works night (3rd) shift.
Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
Any other serious disease or condition at Screening (or Randomization) that would compromise participant safety, might affect life expectancy, or make it difficult to successfully manage and follow the participant according to the protocol.
Randomized in a previous azilsartan medoxomil study.
Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Executive Medical Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Alabaster
State/Province
Alabama
Country
United States
City
Huntsville
State/Province
Alabama
Country
United States
City
Tempe
State/Province
Arizona
Country
United States
City
Freemont
State/Province
California
Country
United States
City
Garden Grove
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Riverside
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Whittier
State/Province
California
Country
United States
City
Newark
State/Province
Delaware
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Hollywood
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Pembroke Pines
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Waycross
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Avon
State/Province
Indiana
Country
United States
City
Elkhart
State/Province
Indiana
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Bingham Farms
State/Province
Michigan
Country
United States
City
Southfield
State/Province
Michigan
Country
United States
City
Florissant
State/Province
Missouri
Country
United States
City
Brooklyn
State/Province
New York
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Salisbury
State/Province
North Carolina
Country
United States
City
Shelby
State/Province
North Carolina
Country
United States
City
Akron
State/Province
Ohio
Country
United States
City
Centerville
State/Province
Ohio
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Willoughby Hills
State/Province
Ohio
Country
United States
City
Zanesville
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Downingtown
State/Province
Pennsylvania
Country
United States
City
Jenkintown
State/Province
Pennsylvania
Country
United States
City
Anderson
State/Province
South Carolina
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Simpsonville
State/Province
South Carolina
Country
United States
City
Spartanburg
State/Province
South Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Friendswood
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Irving
State/Province
Texas
Country
United States
City
Katy
State/Province
Texas
Country
United States
City
Missouri City
State/Province
Texas
Country
United States
City
North Richland Hills
State/Province
Texas
Country
United States
City
Pearland
State/Province
Texas
Country
United States
City
Sugarland
State/Province
Texas
Country
United States
City
Riverton
State/Province
Utah
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Arlington
State/Province
Virginia
Country
United States
City
Burke
State/Province
Virginia
Country
United States
City
Manassas
State/Province
Virginia
Country
United States
City
Port Orchard
State/Province
Washington
Country
United States
City
Aguas Buenas
Country
Puerto Rico
City
Aibonito
Country
Puerto Rico
City
Loiza
Country
Puerto Rico
City
San Juan
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension
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