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)

A Randomized, Double-Blind, Active-Controlled, Multicenter, Crossover Study to Evaluate the Efficacy of Ezetimibe/Atorvastatin 10 mg/40 mg Fixed-Dose Combination Tablet Compared to Co-Administration of Marketed Ezetimibe 10 mg and Atorvastatin 40 mg in Patients With Primary Hypercholesterolemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (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 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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Atorvastatin	40 mg tablet administered orally once daily
DRUG	Ezetimibe	10 mg tablet administered orally once daily
DRUG	Ezetimibe/atorvastatin	Ezetimibe/atorvastatin 10 mg/40 mg combination tablet administered orally once daily
DRUG	Placebo to atorvastatin	Administered orally once daily
DRUG	Placebo to ezetimibe	Administered orally once daily
DRUG	Placebo to ezetimibe/atorvastatin	Administered orally once daily

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-06-10
• Last updated: 2022-02-09
• Results posted: 2013-07-10