NCT00650689

Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With Primary Hypercholesterolemia and Coronary Heart Disease (P03396)

A Multicenter, Randomized, Parallel Groups, Placebo-controlled Study Comparing the Efficacy, Safety, and Tolerability of the Daily Coadministration of Ezetimibe 10 mg With Atorvastatin 10 mg in Untreated Subjects With Primary Hypercholesterolemia and Coronary Heart Disease for Whom Diet and Exercise Have Failed.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the efficacy and safety of coadministration of ezetimibe 10 mg with atorvastatin 10 mg in untreated subjects with primary hypercholesterolemia and coronary heart disease for whom diet and exercise have failed. The primary variable is LDL-cholesterol (LDL-C), and the secondary variable is total cholesterol (TC), HDL-C, and triglycerides (TG). The following variables were used to assess the safety and compliance of the drug: vital signs and laboratory values. Variables were measured before the first administration of the drug and at the last administration of the drug, after 6 weeks of treatment. Adverse events were also assessed.

Conditions

• Hypercholesterolemia
• Atherosclerosis
• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Ezetimibe + Atorvastatin	oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks
DRUG	Atorvastatin	oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks

Timeline

• Start date: 2003-05-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2008-04-02
• Last updated: 2022-02-17