NCT00276458

To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)

A Multicenter., Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at Moderately High Risk for CHD Not Adequately Controlled on Atorvastatin 20 Mg

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Comparator: atorvastatin	Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks
DRUG	Comparator: Placebo	Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks
DRUG	Comparator: ezetimibe	Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.
DRUG	Comparator: Placebo.	Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-01-13
• Last updated: 2024-05-13
• Results posted: 2009-07-08