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

Phase 3 Completed 250 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2008-11
Primary completion: 2010-09
Completion: 2010-09

Outcome

Met primary endpoint

registry analysis (unspecified test); Ezetimibe/Simvastatin 10/40 vs Atorvastatin 40 mg; p <0.001; Difference in Least Squares Means -15.00 (95% CI -21.15 to -8.84) NCT00782184 ↗

Publications

Hing Ling PK, Civeira F, Dan AG, Hanson ME, Massaad R, De Tilleghem Cle B, Milardo C, Triscari J. Ezetimibe/simvastatin 10/40 mg versus atorvastatin 40 mg in high cardiovascular risk patients with primary hypercholesterolemia: a randomized, double-blind, active-controlled, multicenter study. Lipids Health Dis. 2012 Jan 31;11:18. doi: 10.1186/1476-511X-11-18.

Drugs

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