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

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.

Timeline

Start

2003-05

Primary completion

2004-12

Completion

2004-12

Drugs

Indications