Conditions: Essential Hypertension
Keywords: Blood pressure hypertension Exforge valsartan/amlodipine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 932
Healthy volunteers: no

Brief summary:
This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and \<110 mmHg) on valsartan 160 mg alone.

Detailed description:

Arms:
arm 1: One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks arm 2: One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks arm 3: Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.

Interventions: intervention 1: Valsartan/amlodipine 160/5 mg intervention 2: Valsartan 160 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily. intervention 2: Valsartan 160 mg capsule taken orally once daily. intervention 3: 1 capsule or tablet taken orally once daily

Protocol document: