NCT00650663

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

A Multicenter, Double-Blind, Randomized Study to Evaluate the Lipid-Altering Efficacy, Safety, and Tolerability of Ezetimibe Coadministered With Simvastatin Versus Simvastatin Monotherapy in African-American Subjects With Primary Hypercholesterolemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia
• Atherosclerosis

Interventions

Type	Name	Description
DRUG	Ezetimibe + Simvastatin	oral tablets; ezetimibe 10 mg and simvastatin 20 mg once daily for 12 weeks
DRUG	Simvastatin	oral tablet; simvastatin 20 mg once daily for 12 weeks

Timeline

• Start date: 2003-10-01
• Primary completion: 2004-09-01
• Completion: 2004-09-01
• First posted: 2008-04-02
• Last updated: 2024-08-15