Status:

COMPLETED

Atorvastatin Versus Ezetimibe and Fenofibrate as a Lipid-lowering Strategy

Lead Sponsor:

Queen's University

Conditions:

Dyslipidemia

Vascular Disease

Eligibility:

All Genders

18-85 years

Brief 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 atorvast...

Detailed Description

It has been demonstrated in several previous primary and secondary studies that lowering low-density lipoprotein cholesterol (LDL-C) with the use of medications such as 3-hydroxy-3-methylglutaryl-coen...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

January 1 2005

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 1 2006

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT00299884

Start Date

January 1 2005

End Date

July 1 2006

Last Update

March 29 2016

Active Locations (1)

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1

Vascular Disease Prevention and Research Centre, Hotel Dieu Hospital

Kingston, Ontario, Canada, K7L 5G2