drugset / Trial / NCT00425373

Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension

NCT00425373

Phase 2/3 Completed 1474 enrolled Novartis Pharmaceuticals
RandomizedFactorialTriple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies, and placebo.

Timeline

Start
2006-11
Primary completion
2008-03
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 2.5 mg
Subject Amlodipine Other / unclassified 5 mg
Subject Valsartan Small molecule 40 mg
Subject Valsartan Small molecule 80 mg