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

Last updated: January 4, 2012
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

High Blood Pressure (Hypertension)

Circulation Disorders

Stress

Treatment

N/A

Clinical Study ID

NCT01033071
TAK-491CLD_303
U1111-1112-4298
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil plus chlorthalidone, once daily (QD), to olmesartan medoxomil plus hydrochlorothiazide in participants with moderate to severe hypertension.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Has a mean sitting clinic systolic blood pressure greater than or equal to 160 andless than or equal to 190 mm Hg.

  2. Females of childbearing potential who are sexually active agree to routinely useadequate contraception from Screening through 30 days after the last administeredstudy drug dose.

  3. Has clinical laboratory test results within the reference range for the testinglaboratory or the investigator does not consider the results to be clinicallysignificant.

  4. Is willing to discontinue current antihypertensive medications on Day -21 or Day -28if the participant is on amlodipine or chlorthalidone.

Exclusion

Exclusion Criteria:

  1. Has a mean sitting clinic diastolic blood pressure greater than 119 mm Hg on Day -1.

  2. Has a baseline 24-hour ambulatory blood pressure monitoring reading of insufficientquality.

  3. Works a night (third) shift.

  4. Has an upper arm circumference less than 24 cm or greater than 42 cm.

  5. Has secondary hypertension of any etiology.

  6. Has a recent history of myocardial infarction, heart failure, unstable angina,coronary artery bypass graft, percutaneous coronary intervention, hypertensiveencephalopathy, cerebrovascular accident, or transient ischemic attack.

  7. Has clinically significant cardiac conduction defects.

  8. Has hemodynamically significant left ventricular outflow obstruction due to aorticvalvular disease.

  9. Has severe renal dysfunction or disease.

  10. Has known or suspected unilateral or bilateral renal artery stenosis.

  11. Has a history of cancer that has not been in remission for at least 5 years prior tothe first dose of study drug.

  12. Has poorly-controlled diabetes mellitus at Screening.

  13. Has hypokalemia or hyperkalemia.

  14. Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.

  15. Has any other known serious disease or condition that would compromise safety, mightaffect life expectancy, or make it difficult to successfully manage and follow theparticipant according to the protocol.

  16. Has known hypersensitivity to angiotensin II receptor blockers or thiazide-typediuretics or other sulfonamide-derived compounds.

  17. Has a history of drug abuse or a history of alcohol abuse within the past 2 years.

Study Design

Total Participants: 1071
Study Start date:
January 01, 2010
Estimated Completion Date:
November 30, 2010

Study Description

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. 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.

Treatment algorithms for essential hypertension commonly include thiazides or thiazide-like diuretics, either alone or as part of combination treatment. Chlorthalidone is a commercially available, orally administered thiazide-type diuretic agent.

TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker developed by Takeda to treat participants with essential hypertension.

This study will compare the safety and tolerability of azilsartan medoxomil plus chlorthalidone (TAK-491CLD) fixed-dose combination to olmesartan medoxomil plus hydrochlorothiazide fixed-dose combination.

Connect with a study center

  • Abbotsford, British Columbia
    Canada

    Site Not Available

  • Powell River, British Columbia
    Canada

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  • Mount Pearl, Newfoundland and Labrador
    Canada

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  • Halifax, Nova Scotia
    Canada

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  • London, Ontario
    Canada

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  • Ottawa, Ontario
    Canada

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  • Sarnia, Ontario
    Canada

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  • Vaughan, Ontario
    Canada

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  • Whitby, Ontario
    Canada

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  • Woodstock, Ontario
    Canada

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  • Gulf Shores, Alabama
    United States

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  • Litchfield Park, Arizona
    United States

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  • Mesa, Arizona
    United States

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  • Scottsdale, Arizona
    United States

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  • Tucson, Arizona
    United States

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  • Buena Park, California
    United States

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  • Carmichael, California
    United States

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  • Greenbrae, California
    United States

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  • Irvine, California
    United States

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  • Paramount, California
    United States

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  • Sacramento, California
    United States

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  • San Diego, California
    United States

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  • San Francisco, California
    United States

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  • Spring Valley, California
    United States

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  • Wildomar, California
    United States

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  • Colorado Springs, Colorado
    United States

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  • Milford, Connecticut
    United States

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  • Waterbury, Connecticut
    United States

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  • Newark, Delaware
    United States

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  • Aventura, Florida
    United States

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  • Clearwater, Florida
    United States

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  • Deland, Florida
    United States

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  • Fort Lauderdale, Florida
    United States

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  • Miami, Florida
    United States

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  • Ocala, Florida
    United States

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  • Plant City, Florida
    United States

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  • Tallahassee, Florida
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  • Tampa, Florida
    United States

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  • West Palm beach, Florida
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  • Winter Haven, Florida
    United States

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  • Dunwoody, Georgia
    United States

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  • Roswell, Georgia
    United States

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  • Suwanee, Georgia
    United States

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  • Chicago, Illinois
    United States

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  • Melrose Park, Illinois
    United States

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  • Naperville, Illinois
    United States

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  • Avon, Indiana
    United States

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  • Indianapolis, Indiana
    United States

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  • Valparaiso, Indiana
    United States

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  • Crestview Hills, Kentucky
    United States

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  • Lexington, Kentucky
    United States

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  • Auburn, Maine
    United States

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  • Brockton, Massachusetts
    United States

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  • Hyannis, Massachusetts
    United States

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  • West Yarmouth, Massachusetts
    United States

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  • Ann Arbor, Michigan
    United States

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  • St Louis, Missouri
    United States

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  • St Peters, Missouri
    United States

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  • Henderson, Nevada
    United States

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  • Margate, New Jersey
    United States

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  • Wildwood Crest, New Jersey
    United States

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  • Albuquerque, New Mexico
    United States

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  • Glens Falls, New York
    United States

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  • Boiling Springs, North Carolina
    United States

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  • Raleigh, North Carolina
    United States

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  • Salisbury, North Carolina
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  • Cincinnati, Ohio
    United States

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  • Columbus, Ohio
    United States

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  • Willoughby Hills, Ohio
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  • Oklahoma City, Oklahoma
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  • Yukon, Oklahoma
    United States

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  • Ashland, Oregon
    United States

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  • Portland, Oregon
    United States

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  • Bensalem, Pennsylvania
    United States

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  • Feasterville, Pennsylvania
    United States

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  • Lansdale, Pennsylvania
    United States

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  • Pittsburgh, Pennsylvania
    United States

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  • Reading, Pennsylvania
    United States

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  • Tipton, Pennsylvania
    United States

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  • Cranston, Rhode Island
    United States

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  • Cumberland, Rhode Island
    United States

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  • Mt Pleasant, South Carolina
    United States

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  • Simpsonville, South Carolina
    United States

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  • Beaumont, Texas
    United States

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  • Dallas, Texas
    United States

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  • Houston, Texas
    United States

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  • North Richland Hills, Texas
    United States

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  • San Antonio, Texas
    United States

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  • Magna, Utah
    United States

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  • Manassas, Virginia
    United States

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  • Lakewood, Washington
    United States

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  • Port Orchard, Washington
    United States

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  • Madison, Wisconsin
    United States

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  • Menomonee Falls, Wisconsin
    United States

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