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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Valsartan 160 mg; Drug: Valsartan 80 mg; Drug: Valsartan/amlodipine 80/5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00413413

CVAA489A2316

Details and patient eligibility

About

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

Enrollment: 1,134 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,134 participants in 3 patient groups

Valsartan/amlodipine 80/5 mg

Experimental group

Treatment:

Drug: Valsartan/amlodipine 80/5 mg

Valsartan 80 mg

Active Comparator group

Treatment:

Drug: Valsartan 80 mg

Valsartan 160 mg

Active Comparator group

Treatment:

Drug: Valsartan 160 mg