drugset / Trial / NCT00254475

A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential Hypertension and Hypercholesterolemia

NCT00254475

Phase 3 Completed 871 enrolled Novartis
RandomizedSingle-groupDouble-blindTreatment

Summary

The purpose of this study is to provide data on the dose response of simvastatin in lowering LDL-C when it is co-administered with valsartan in patients with both essential hypertension and hypercholesterolemia. The primary objective of the study will be to show that the combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the combination of valsartan 160mg/simvastatin 20mg in percentage change from baseline in LDL-C.

Timeline

Start
2005-11
Primary completion
2006-09
Completion
2006-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Simvastatin Small molecule 20 mg
Subject Simvastatin Small molecule 40 mg
Subject Valsartan Small molecule 320 mg