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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Medical University of Graz

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stojakovic T, de Campo A, Scharnagl H, Sourij H, Schmölzer I, Wascher TC, März W. Differential effects of fluvastatin alone or in combination with ezetimibe on lipoprotein subfractions in patients at high risk of coronary events. Eur J Clin Invest. 2010 Mar;40(3):187-94. doi: 10.1111/j.1365-2362.2009.02249.x. Epub 2010 Jan 7.

Responsible Party:	Prof. Dr. Winfried März, Medical University of Graz
ClinicalTrials.gov Identifier:	NCT00814723 History of Changes
Other Study ID Numbers:	2004-002535-12
First Posted:	December 25, 2008
Last Update Posted:	December 25, 2008
Last Verified:	December 2008

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Ezetimibe; Fluvastatin	Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors