Atorvastatin Versus Ezetimibe and Fenofibrate as a Lipid-lowering Strategy

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary aim of this study is to evaluate the efficacy and non-inferiority of a lipid-lowering medication regimen comprised of the medications ezetimibe and fenofibrate taken daily, versus atorvastatin daily in lowering levels of low-density lipoprotein (LDL-C) cholesterol. Additionally, other aims would include effects on other types of blood cholesterol and examining the safety of the ezetimibe and fenofibrate regimen, as compared to atorvastatin.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen's University
• Treatments: Atorvastatin; Atorvastatin Calcium; Ezetimibe; Fenofibrate

Criteria

Inclusion Criteria:

-Study is confined to subjects with elevated LDL-C levels 3.0 mmol/L and greater.

Exclusion Criteria:

• Abnormal liver enzymes (ie, AST, ALT greater than three times the upper limit of normal);

• Creatine kinase levels more than two times the upper limit of normal;

• Uncontrolled ethanol use (this may affect compliance);

• Pregnant or breastfeeding women or women not using adequate contraceptive methods;

• Previous history of intolerance or adverse effects with statins;

• Previous history of intolerance or adverse effects with fibric acid derivatives;

• Previous history of intolerance or adverse effects with ezetimibe;

• Uncontrolled diabetes (HbA1c > 10%);

• Recent myocardial infarction (within 6 weeks);

• Concurrent enrollment in another study.