A Study to Evaluate the Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled on Monotherapy

Novartis

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: amlodipine

Drug: valsartan

Drug: hydrochlorothiazide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00327145

CVAA489A2401

Details and patient eligibility

About

This study is designed to provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg with possible addition of HCTZ

Enrollment

894 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Male or female patients ≥18 years of age
Non-diabetic patients must have MSSBP of ≥140 mmHg and/or MSDBP ≥90 mmHg at Visits 1 and 2. Diabetic patients must have MSSBP ≥130 mmHg and/or MSDBP ≥80 mmHg at Visits 1 and 2
Patients treated with monotherapy at a dose considered as adequate by the investigator for a minimum of two months prior to Visit 1

Exclusion criteria

Known or suspected contraindications, including history of allergy to ARBs, CCB, thiazides or to drugs with similar chemical structure.
MSSBP ≥180 mmHg and/or MSDBP ≥110 mmHg (MSSBP ≥160 mmHg and/or MSDBP ≥100 mmHg for diabetic patients) at any time between Visit 1 and Visit 2.
Evidence of a secondary form of hypertension, to include coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma.
Known Keith-Wagener grade III or IV hypertensive retinopathy.
Other exclusion criteria apply