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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00814723
Recruitment Status : Completed
First Posted : December 25, 2008
Last Update Posted : December 25, 2008
Information provided by:
Medical University of Graz

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: fluvastatin Drug: Fluvastatin plus ezetimibe Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk
Study Start Date : September 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Arm Intervention/treatment
Active Comparator: Fluvastatin
Fluvastatin 80 mg MR
Drug: fluvastatin
80 mg MR, 12 weeks
Other Name: 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 Name: Lescol, Ezetrol

Primary Outcome Measures :
  1. Reduction in Low density lipoprotein cholesterol (LDL-C) [ Time Frame: week 6 and 12 ]

Secondary Outcome Measures :
  1. Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP [ Time Frame: week 6 and 12 ]
  2. adverse events, CK elevation, liver enzyme elevation [ Time Frame: week 6, 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00814723

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Depart. of Internal Medicine, Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
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Principal Investigator: Winfried März, Prof., M.D. Medical University of Graz, Synlab Medizinisches Versorgungszentrum für Labordiagnostik Heidelberg
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. Winfried März, Medical University of Graz Identifier: NCT00814723    
Other Study ID Numbers: 2004-002535-12
First Posted: December 25, 2008    Key Record Dates
Last Update Posted: December 25, 2008
Last Verified: December 2008
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents