drugset / Trial / NCT00327145

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

NCT00327145

Phase 3 Completed 894 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start
2006-03
Primary completion
2007-01
Completion
2007-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 5 mg
Subject Amlodipine Other / unclassified 10 mg
Subject Valsartan Small molecule 160 mg
Background Hydrochlorothiazide Unknown

Indications