Atorvastatin Versus Ezetimibe and Fenofibrate as a Lipid-Lowering Strategy

This study has been completed.
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00299884
First received: September 9, 2005
Last updated: May 13, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Dyslipidemia
Vascular Disease
Drug: Lipitor 20 mg
Drug: Combination Ezetrol 10 mg and Lipidil Supra 160 mg
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Comparison of the Efficacy of Ezetimibe and Fenofibrate Versus Atorvastatin Alone in the Lowering of LDL Cholesterol

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • To examine the efficacy of a combination of ezetimibe and fenofibrate in comparison with that of atorvastatin in lowering LDL-C. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To examine the efficacy of a combination of ezetimibe and fenofibrate in comparison with that of atorvastatin in lowering triglyceride levels, raising HDL-C levels and lowering of hsCRP levels. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Apo-lipo B


Enrollment: 45
Study Start Date: January 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Lipitor 20 mg
Drug: Lipitor 20 mg
A/A for 6 weeks
2
Lipidil Supra 160 mg and Ezetrol 10 mg
Drug: Combination Ezetrol 10 mg and Lipidil Supra 160 mg
a/a for 6 weeks

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-coenzyme A (HMG-CoA) reductase inhibitors improves mortality and morbidity related to cardiovascular events in patients with hypercholesterolemia. Such inhibitors, which are known as 'statins', act to block the synthesis of cholesterol in the liver. These medications are generally well tolerated by the vast majority of patients, but a small number experience side effects, most seriously those of myopathies, rhabdomyolysis and elevated liver enzymes - recognition of this fact, that statins are not universally without problems, highlights the need for viable alternatives.

Ezetimibe is a relatively new medication in Canada, approved for use in patients with cholesterol problems. It is an intestinal cholesterol binder that is known to be well-tolerated, with side effects similar to placebo. Alone, it has a modest effect in the lowering of LDL-C. Fenofibrate is a medication that also works through the liver and has long been used to adjust blood lipid levels in patients with mixed lipid problems. Alone it also has a modest effect in the lowering of LDL-C. Recent study, however, has shown that the effect of ezetimibe and fenofibrate together in the lowering of LDL-C is greater than that of either drug alone. This combination, if as effective in this regard as atorvastatin, would prove a valid alternative to the use of the atorvastatin in the lowering of LDL-C, and a benefit for patients who have had problems tolerating statin therapy but still require medication for elevated cholesterol.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects aged 18-85 with elevated LDL-C levels 3.0 mmol/L and greater.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299884

Locations
Canada, Ontario
Vascular Disease Prevention and Research Centre, Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Stephen A LaHaye, MD Vascular Disease Prevention and Research Centre
  More Information

No publications provided

Responsible Party: Stephen LaHaye, QUEEN'S UNIVERSITY
ClinicalTrials.gov Identifier: NCT00299884     History of Changes
Other Study ID Numbers: DMED-816-04
Study First Received: September 9, 2005
Last Updated: May 13, 2008
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Randomized
non-blinded
prospective
open-label
LDL-C
HDL-C

Additional relevant MeSH terms:
Vascular Diseases
Dyslipidemias
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Atorvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014