drugset / Trial / NCT00651014

Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)

NCT00651014

Phase 4 Terminated 82 enrolled Organon and Co Merck Frosst Canada Ltd. · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

The study was designed to assess whether 6 weeks of co-administration of ezetimibe and simvastatin is more effective than simvastatin monotherapy in allowing patients in the CHD risk strata of the NCEP III guidelines to achieve their LDL-C target goal of \<=3.0 mmol/L. As this study was to be conducted in Canada, the target LDL-C goal for patients with CHD, or type II diabetic patients \>30 years old with no CHD, was \<2.5 mmol/L.

Timeline

Start
2004-01
Primary completion
2006-06
Completion
2006-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg Oral