Clinical trial NCT00696436
Conditions: Hypertension
Keywords: Essential Hypertension Cardiovascular Disease High Blood Pressure Drug Therapy
Sponsor: Takeda
Start date: 2008-04-01; Completion date: 2009-08-01
Enrollment: 1291 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to placebo, valsartan and olmesartan in 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 successfully maintain control.

A major component of blood pressure regulation is the renin-angiotensin-aldosterone system. This is a system of hormone-mediated feedback interactions that result 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 and has multiple effects on the cardiovascular system and on electrolyte homeostasis.

TAK-491 (azilsartan medoxomil) is an angiotensin II type 1 receptor antagonist currently being tested as a treatment for essential hypertension.

Study participation is anticipated to be about 10 weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations, electrocardiograms and ambulatory blood pressure monitoring. Outside of the study center, participants will be required wear an ambulatory blood pressure monitoring device at 24 hour intervals.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Azilsartan medoxomil intervention 2: Azilsartan medoxomil intervention 3: Valsartan intervention 4: Olmesartan intervention 5: Placebo
Intervention descriptions: intervention 1: Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks. intervention 2: Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks. intervention 3: Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks. intervention 4: Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks. intervention 5: Matching placebo, orally, once daily for up to six weeks.

Protocol documents: