Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Amlodipine Alone

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: valsartan/amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171002

CVAA489A2306

Details and patient eligibility

About

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication

Enrollment: 936 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with uncomplicated, essential hypertension

Exclusion criteria

• Severe hypertension
• History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
• Liver, kidney, or pancreas disease
• Insulin dependent diabetes
• Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind