Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension

NCT00591253 | Completed Phase 3 Results

• 2 other identifiers: 01-06-TL-491-011U1111-1113-8925
• Study Type: interventional
• Target: 413
• Locations: 2 countries
• Sites: 64

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.

Conditions

Hypertension

Keywords

Blood pressure; blood pressure monitoring ambulatory; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 6.

Secondary Outcomes (14)

• Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure

  Baseline and Week 6.

• Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

  Baseline and Week 6.

• Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure

  Baseline and Week 6.

• Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

  Baseline and Week 6.

• Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

  Baseline and Week 6.

Study Arms (3)

Azilsartan Medoxomil 40 mg QD

EXPERIMENTAL

Drug: Azilsartan medoxomil

Azilsartan Medoxomil 80 mg QD

EXPERIMENTAL

Drug: Azilsartan medoxomil

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Azilsartan medoxomil DRUG

Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.

Also known as: TAK-491, Edarbi

Azilsartan Medoxomil 40 mg QD

Placebo DRUG

Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.

Placebo QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willing to discontinue current antihypertensive medication.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (64)

Unknown Facility

Alabaster, Alabama, United States

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Huntsville, Alabama, United States

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Tempe, Arizona, United States

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Freemont, California, United States

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Garden Grove, California, United States

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Long Beach, California, United States

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Riverside, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Whittier, California, United States

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Newark, Delaware, United States

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Hialeah, Florida, United States

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Hollywood, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Atlanta, Georgia, United States

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Waycross, Georgia, United States

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Chicago, Illinois, United States

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Avon, Indiana, United States

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Elkhart, Indiana, United States

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Indianapolis, Indiana, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Ann Arbor, Michigan, United States

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Bingham Farms, Michigan, United States

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Southfield, Michigan, United States

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Florissant, Missouri, United States

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Brooklyn, New York, United States

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Hickory, North Carolina, United States

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Raleigh, North Carolina, United States

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Salisbury, North Carolina, United States

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Shelby, North Carolina, United States

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Akron, Ohio, United States

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Centerville, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Willoughby Hills, Ohio, United States

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Zanesville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Downingtown, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Simpsonville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Dallas, Texas, United States

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Friendswood, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Katy, Texas, United States

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Missouri City, Texas, United States

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North Richland Hills, Texas, United States

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Pearland, Texas, United States

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Sugarland, Texas, United States

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Riverton, Utah, United States

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Salt Lake City, Utah, United States

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Arlington, Virginia, United States

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Burke, Virginia, United States

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Manassas, Virginia, United States

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Port Orchard, Washington, United States

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Aguas Buenas, Puerto Rico

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Aibonito, Puerto Rico

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Loíza, Puerto Rico

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San Juan, Puerto Rico

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MeSH Terms

Conditions

Hypertension

Interventions

azilsartan medoxomil; azilsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sr. VP, Clinical Science
• Organization: Takeda Global Research and Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Executive Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 11, 2008
• Study Start: October 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 19, 2011
• Results First Posted: April 19, 2011

Record last verified: 2011-03

Locations

PR (4); US (60)