NCT00782184

Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)

A Randomized, Double-Blind, Active-Controlled Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With Atorvastatin: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin Versus Doubling the Baseline Dose of Atorvastatin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ezetimibe/simvastatin 10/40	ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks.
DRUG	atorvastatin 40 mg	atorvastatin 40 mg tablet once daily for 6 weeks
DRUG	atorvastatin 20 mg	All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-10-31
• Last updated: 2024-05-16
• Results posted: 2011-10-31