NCT00409773

Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,143 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypercholesterolemia
• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	ezetimibe (+) simvastatin	Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
DRUG	Comparator: atorvastatin calcium	Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
DRUG	Comparator: Placebo (unspecified)	Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2006-12-11
• Last updated: 2024-05-16
• Results posted: 2009-08-04