Efficacy and Safety of Azilsartan Medoxomil, Once Daily (QD), Co-Administered With Amlodipine in Participants With Essential Hypertension

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypertension

In brief

The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), co-administered with amlodipine in treating individuals with essential hypertension, compared to treatment with amlodipine alone.

Key facts

Study ID

NCT00591266

Run by

Takeda

People needed

566

Starts

2007-10-01

Expected to finish

2009-04-01

Last updated by the study team

2011-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has essential hypertension and 24-hour mean systolic blood pressure greater than or equal to 140 mm Hg and less than or equal to 180 mm Hg.
• 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 evaluations within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
• Is willing to discontinue current antihypertensive medications.

You may not qualify if…

• Has sitting trough clinic diastolic blood pressure greater than 119 mm Hg.
• Has a baseline 24 hour ambulatory blood pressure monitoring reading of insufficient quality.
• The subject is hypersensitive to angiotensin II receptor blockers or calcium channel blockers.
• Has a 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 secondary hypertension of any etiology
• Is non-compliant with study medication during placebo run-in period.
• Has severe renal dysfunction or disease.
• Has known or suspected unilateral or bilateral renal artery stenosis.
• Has a history of drug abuse or a history of alcohol abuse within the past 2 years.
• Has a previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
• Has type 1 or poorly controlled type 2 diabetes mellitus.
• Has hyperkalemia as defined by the central laboratory normal reference range,
• Has an alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease or jaundice.
• Has an upper arm circumference less than 24 cm or greater than 42 cm.
• Works night (3rd) shift.
• Currently participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
• Has any other serious disease or condition that would compromise subject safety or make it difficult to successfully manage and follow the subject according to the protocol.
• Has been randomized in a previous TAK-491 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.

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Burbank, California, United States
• Study site — Burlingame, California, United States
• Study site — La Jolla, California, United States
• Study site — Orange, California, United States
• Study site — Roseville, California, United States
• Study site — Tustin, California, United States
• Study site — Wheat Ridge, Colorado, United States
• Study site — Newark, Delaware, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Hialeah, Florida, United States
• Study site — Longwood, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Gurnee, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — Elkhart, Indiana, United States
• Study site — Crestview Hills, Kentucky, United States
• Study site — Lexington, Kentucky, United States
• Study site — Riverdale, Maryland, United States

Full record on ClinicalTrials.gov

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