drugset / Trial / NCT01370603

A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)

NCT01370603

Phase 3 Completed 328 enrolled Organon and Co
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/40 mg combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin 40 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.

Timeline

Start
2011-09
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atorvastatin Small molecule 40 mg Oral
Comparator Ezetimibe Unknown 10 mg Oral
Subject Ezetimibe/atorvastatin Unknown 10 mg Oral
Subject Ezetimibe/atorvastatin Unknown 40 mg Oral

Indications