Conditions: Hypertension High Blood Pressure
Keywords: Hypertension valsartan amlodipine high blood pressure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

Brief summary:
The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood pressure in Taiwanese patients.

Detailed description:

Arms:
arm 1: During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks. arm 2: In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks. arm 3: During run-in period, oral valsartan 80 mg once daily for 4 weeks.

Interventions: intervention 1: Amlodipine 5mg/Valsartan 80 mg intervention 2: Valsartan
Intervention descriptions: intervention 1: Combination therapy of Amlodipine/Valsartan 5mg/80mg one dosage daily with one single tablet size for 8 weeks. intervention 2: For run-in period, Valsartan 80 mg daily in one dosage with one single tablet size for 4 weeks.

Monotherapy for double blind treatment period in one dosage (Valsartan 160mg) daily with one single tablet size for 8 weeks

Protocol document: