Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk

December 24, 2008 updated by: Medical University of Graz
Patients with coronary heart disease (CHD) or CHD equivalent (e. g. diabetes mellitus) often have abnormalities in lipids (hypercholesterolemia). Besides, hypercholesterolemia is an evident risk factor for atherosclerosis. Hitherto, there are only few studies of patients with primary hypercholesterolemia where the combination therapy with statins (HMG-Co-reductase inhibitors) and ezetimib was investigated. This combination therapy should be more effective in reducing low density lipoprotein cholesterol (LDL-C) and total cholesterol levels compared to monotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ezetimibe, a cholesterol-absorption inhibitor, significantly lowers low-density lipoprotein cholesterol (LDL-C) when administered in addition to statin treatment. The effect of ezetimibe on the incidence and progression of vascular disease is elusive. Therefore, our objective was to examine the effects of fluvastatin and fluvastatin plus ezetimibe on lipoprotein subfractions in patients with diabetes mellitus and/or coronary heart disease.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Depart. of Internal Medicine, Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with CHD or CHD equivalent with LDL 100-160 mg/dl
  • Male or female sex
  • Normal values of CK, AST and ALT
  • Normal kidney function

Exclusion Criteria:

  • CHD Stage III-IV
  • St. p. myocardial infarction or coronary artery bypass grafting
  • Pregnancy or breastfeeding
  • Premenopausal women without certain contraception
  • Known hypersensitivity to HMG-CoA reductase inhibitors or ezetimib

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fluvastatin
Fluvastatin 80 mg MR
Drug: fluvastatin
80 mg MR, 12 weeks
Other Names:
  • Lescol
Active Comparator: Fluvastatin + Ezetimibe
Fluvastatin MR 80 mg plus Ezetimibe 10 mg
Drug: Fluvastatin plus ezetimibe
fluvastatin 80 mg MR plus ezetimibe 10 mg
Other Names:
  • Lescol, Ezetrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in Low density lipoprotein cholesterol (LDL-C)
Time Frame: week 6 and 12
week 6 and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP
Time Frame: week 6 and 12
week 6 and 12
adverse events, CK elevation, liver enzyme elevation
Time Frame: week 6, 12
week 6, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Winfried März, Prof., M.D., Medical University of Graz, Synlab Medizinisches Versorgungszentrum für Labordiagnostik Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

December 24, 2008

First Submitted That Met QC Criteria

December 24, 2008

First Posted (Estimate)

December 25, 2008

Study Record Updates

Last Update Posted (Estimate)

December 25, 2008

Last Update Submitted That Met QC Criteria

December 24, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-002535-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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