Long-term tolerability and efficacy of the combination of amlodipine/valsartan in hypertensive patients: a 54-week, open-label extension study.

Objective: To evaluate the long-term tolerability and efficacy of the amlodipine/valsartan 5/320 mg once daily (o.d.) combination in hypertensive patients.

Two multicenter, 8-week, randomized, double-blind, placebo-controlled, parallel-group studies evaluating the efficacy and tolerability of amlodipine and valsartan in combination and as monotherapy in adult patients with mild to moderate essential hypertension.

Background: Patients with hypertension may require combination therapy to attain the blood pressure targets recommended by US and European treatment guidelines. Combination therapy with a calcium channel blocker and an angiotensin II-receptor blocker would be expected to provide enhanced efficacy.

Objectives: Two studies were conducted to compare the efficacy of various combinations of amlodipine and valsartan administered once daily with their individual components and placebo in patients with mild to moderate essential hypertension (mean sitting diastolic blood pressure [MSDBP] >/=95 and < 110 mm Hg).