A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease

NCT00409773 Phase 3 COMPLETED Results posted

A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.

Details

Lead sponsor	Organon and Co
Phase	Phase 3
Status	COMPLETED
Enrolment	1143
Start date	2007-01
Completion	2008-07

Conditions

• Hypercholesterolemia
• Metabolic Syndrome

Interventions

• ezetimibe (+) simvastatin
• Comparator: atorvastatin calcium
• Comparator: Placebo (unspecified)

Primary outcomes

• Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 — Baseline and 6 Weeks