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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Amlodipine; Valsartan

Criteria

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.