Conditions: Hypertension
Keywords: Blood pressure hypertension elderly
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 965
Healthy volunteers: no

Brief summary:
To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.

Detailed description:

Arms:
arm 1: 1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily arm 2: 1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily arm 3: 1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily

Interventions: intervention 1: Amlodipine 5 mg intervention 2: Valsartan 80 mg intervention 3: Valsartan 40 mg intervention 4: Placebo
Intervention descriptions: intervention 1: 1 capsule amlodipine 5 mg orally once daily intervention 2: 1 capsule valsartan 80 mg orally once daily intervention 3: 1 capsule valsartan 40 mg orally once daily intervention 4: 1 capsule placebo to match valsartan orally once daily

Protocol document: