Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension

A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of Valsartan/Amlodipine-based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension

This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).

Inclusion Criteria:

• Male or female outpatient of 18 years of age or greater
• Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure (MSSBP) greater than or equal to 160 and < 200 mmHg at randomization
• Patients who were able to participate in the study, and who gave written informed consent before any study assessment was performed.

Exclusion Criteria:

• Office systolic blood pressure >200 and/or mean sitting diastolic blood pressure (MSDBP) greater than or equal to 110 mmHg at Visit 1.
• Use of four (4) or more antihypertensive medications within 30 days of Visit 1.
• Refractory hypertension, defined as blood pressure >140/90 mmHg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with a fixed-dose combination of two active medications represents two drugs).
• Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply