drugset / Trial / NCT00400777

Efficacy and Safety of Valsartan, Hydrochlorothiazide and Amlodipine Combination Therapy in Hypertension

NCT00400777

Phase 4 Completed 460 enrolled Novartis
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to evaluate the efficacy and safety of the combination valsartan with hydrochlorothiazide and amlodipine in hypertensive patients previously treated with valsartan with hydrochlorothiazide and remaining uncontrolled. A naturalistic approach will be taken comparing two different possible ways to achieve the higher dosage of the triple combination, i.e. 160 mg of valsartan and 25 mg of hydrochlorothiazide with amlodipine 10 mg.

Timeline

Start
2006-08
Primary completion
2007-11
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 10 mg
Subject Hydrochlorothiazide Unknown 25 mg
Subject Valsartan Small molecule 160 mg

Indications