Conditions: Essential Hypertension
Keywords: Hypertension, Valsartan, Amlodipine, high blood pressure
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 1474
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies, and placebo.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None

Interventions: intervention 1: Valsartan + amlodipine 40/2.5 mg intervention 2: Valsartan + amlodipine 40/5 mg intervention 3: Valsartan + amlodipine 80/2.5 mg intervention 4: Valsartan + amlodipine 80/5 mg intervention 5: Valsartan 40 mg intervention 6: Valsartan 80 mg intervention 7: Amlodipine 2.5 mg intervention 8: Amlodipine 5 mg intervention 9: Placebo
Intervention descriptions: intervention 1: Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 2: Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 3: Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 4: Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 5: Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 6: Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 7: Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily intervention 8: Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily intervention 9: 4 tablet and 2 capsule placebos taken once daily

Protocol document: