Conditions: Hypertension
Keywords: hypertension blood pressure diastolic blood pressure drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 449
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with 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. Data from the Framingham Heart study suggest that the lifetime risk of developing hypertension among 55- to 65-year-old individuals is greater than 90%. 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 hypertension treatments, hypertension remains inadequately controlled; only about one third of patients continue to maintain control successfully. To help address these matters, the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure proposes a more aggressive intervention to hypertension management with more potent antihypertensive agents and combination therapy.

Takeda Global Research \& Development Center, Inc. is developing TAK-491 (azilsartan medoxomil) to treat mild to moderate essential hypertension. Azilsartan medoxomil is a prodrug that is rapidly hydrolyzed to the activity moiety, azilsartan, which is an angiotensin II type 1 receptor antagonist. This study is proposed to evaluate the efficacy, safety and tolerability of multiple doses of azilsartan medoxomil at five dose levels in subjects with mild to moderate uncomplicated essential hypertension.

Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 11 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 approximately 24 and 36 hour intervals.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None

Interventions: intervention 1: Azilsartan Medoxomil intervention 2: Azilsartan Medoxomil intervention 3: Azilsartan Medoxomil intervention 4: Azilsartan Medoxomil intervention 5: Azilsartan Medoxomil intervention 6: Olmesartan intervention 7: Placebo
Intervention descriptions: intervention 1: Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 2: Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 3: Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 4: Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 5: Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 6: Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 7: Matching placebo tablets, orally, once daily for up to 8 weeks.

Protocol document: