Conditions: Hypertension
Keywords: hypertension, valsartan, amlodipine
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 257
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).

Detailed description:
Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg

Arms:
arm 1: During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.

Interventions: intervention 1: Amlodipine intervention 2: Olmesartan medoxomil intervention 3: Amlodipine+valsartan intervention 4: Hydrochlorothiazide
Intervention descriptions: intervention 1: Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only. intervention 2: Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only. intervention 3: Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase. intervention 4: Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.

Protocol document: