drugset / Trial / NCT00171093

A 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and Hypercholesterolemia

NCT00171093

Phase 3 Completed 369 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

Summary

This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and 80 mg simvastatin together compared to using either one alone in lowering blood pressure and LDL cholesterol. After discontinuing current drug therapies for hypertension and hypercholesterolemia, patients will be given 320mg valsartan+80mg simvastatin, 320mg valsartan+placebo, or 80mg simvastatin+placebo..

Timeline

Start
2004-09
Primary completion
2006-01
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Simvastatin Small molecule 80 mg
Subject Valsartan Small molecule 320 mg