NCT00423579

The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)

A Multicenter, Randomized, Parallel-Groups, Double-Blind Placebo-Controlled Study Comparing the Efficacy, Safety, and Tolerability of Administration of Ezetimibe/Simvastatin Tablet 10/20 mg Versus Doubling the Dose of Simvastatin 20 mg [Simvastatin 40 mg] in Subjects With Primary Hypercholesterolemia and Coronary Heart Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of simvastatin to 40 mg in patients with hypercholesterolemia and coronary heart disease.

Conditions

• Hypercholesterolemia
• Coronary Disease

Interventions

Type	Name	Description
DRUG	Ezetimibe/Simvastatin 10/20 mg	1 tablet containing 10 mg of ezetimibe and 20 mg of simvastatin per day for 6 weeks
DRUG	simvastatin 40 mg	1 tablet containing 40 mg of simvastatin per day for 6 weeks

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-01-18
• Last updated: 2024-05-22
• Results posted: 2009-08-25