NCT00418834

Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)

A Multicenter, Randomized, Double-Blind, Parallel Arm, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg When Added to Atorvastatin 10 mg Versus Titration to Atorvastatin 20 mg and to 40 mg in Elderly Patients With Hypercholesterolemia at High Risk for CHD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,053 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ezetimibe and atorvastatin	ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks
DRUG	atorvastatin	Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks
DRUG	Placebo (unspecified)	Placebo (unspecified) daily for 12 weeks

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-01-05
• Last updated: 2024-05-14
• Results posted: 2009-10-06