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

Phase 3 Completed 196 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2006-02
Primary completion: 2008-01
Completion: 2008-01

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Atorvastatin + Ezetimibe: -30.8 (-34.5 to -27.0) Percent NCT00276458 ↗

registry Atorvastatin + Ezetimibe vs Atorvastatin; p <0.001; Mean Difference (Final Values) -19.9 (95% CI -25.2 to -14.5); ANCOVA NCT00276458 ↗

Publications

Background Conard SE, Bays HE, Leiter LA, Bird SR, Rubino J, Lowe RS, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (20 mg) versus uptitration of atorvastatin (to 40 mg) in hypercholesterolemic patients at moderately high risk for coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1489-94. doi: 10.1016/j.amjcard.2008.09.075. Epub 2008 Oct 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Atorvastatin	Small molecule	20 mg	Oral
Comparator	Atorvastatin	Small molecule	40 mg	Oral
Subject	Ezetimibe	Unknown	10 mg	Oral