drugset / Trial / NCT00650663

Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377)

NCT00650663

Phase 4 Completed 247 enrolled Organon and Co Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate whether coadministration of ezetimibe 10 mg/day with simvastatin 20 mg/day for 12 weeks will result in greater reduction of LDL-C, total cholesterol (TC), triglycerides (TG), non HDL-C, and apolipoprotein B (ApoB), and greater increase in HDL-C, compared with simvastatin 20 mg/day as monotherapy for 12 weeks in African-American subjects with primary hypercholesterolemia. This study is being performed to better define the efficacy of ezetimibe coadministered with simvastatin in this population.

Timeline

Start
2003-10-01
Primary completion
2004-09-01
Completion
2004-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg Oral
Subject Simvastatin Small molecule 20 mg Oral