Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension

A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controled, Parallel Study, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Valsartan 80 mg and Valsartan 160 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 80 mg Monotherapy.

This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.

Inclusion Criteria:

• Male or female outpatients >= 18 years and < 86 years
• Patients with essential diastolic hypertension
• At visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmHg and < 10 mmHg; patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure < 100 mmHg
• At visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmHg and < 100 mmHg
• At visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmHg and < 110 mmHg

Exclusion Criteria:

• Severe hypertension >= 180/110 mmHg
• Known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
• Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to Visit 2
• History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
• Malignant hypertension
• All patients with Type I diabetes and those patients with Type 2 diabetes who are not well controlled based on the investigator's clinical judgment
• Pregnant or nursing women
• History of heart failure
• Angina pectoris
• Second or third degree heart block
• Life threatening or symptomatic arrhythmias
• Clinically significant valvular heart disease
• Evidence of a secondary form of hypertension
• Known or moderate malignant retinopathy
• Evidence of hepatic disease
• Evidence of renal impairment

Other protocol-defined exclusion criteria may apply.