Clinical trial NCT00591773
Conditions: Hypertension
Keywords: Blood pressure Blood pressure monitoring, ambulatory
Sponsor: Takeda
Start date: 2007-09-01; Completion date: 2009-03-01
Enrollment: 551 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), co-administered with chlorthalidone in treating individuals with essential hypertension, compared to treatment with chlorthalidone alone.

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.

TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker that was shown to be a orally active antihypertensive agent with a prolonged duration of activity and good safety tolerability in a recent clinical study. Chlorthalidone is a thiazide-like diuretic that reduces blood pressure by decreasing intravascular volume through urinary salt and water excretion. By combining this action with azilsartan medoxomil, a greater reduction in blood pressure is expected than with either agent alone. For subjects requiring combination therapy, azilsartan medoxomil plus chlorthalidone offers a novel combination that may provide a more potent and safe combination for blood pressure reduction.

This study is being conducted to determine whether administration of azilsartan medoxomil in combination with chlorthalidone to subjects with uncontrolled hypertension is more effective in reducing blood pressure than chlorthalidone alone. This study is also being conducted to evaluate the safety and tolerability of azilsartan medoxomil combined with chlorthalidone.

Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 10 Weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations, electrocardiogram. Outside of the study center, participants will be required to wear an ambulatory blood pressure monitoring device at 24 hour intervals.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Azilsartan medoxomil and chlorthalidone intervention 2: Azilsartan medoxomil and chlorthalidone intervention 3: Chlorthalidone
Intervention descriptions: intervention 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily; azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily; and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks. intervention 2: Azilsartan medoxomil 80 mg, tablets, orally, once daily; azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks. intervention 3: Chlorthalidone 25 mg, tablets, orally, once daily; azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily and azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily for up to 6 weeks.

Protocol documents: