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

NCT ID: NCT00814723

Last Updated: 2008-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fluvastatin

Fluvastatin 80 mg MR

Group Type ACTIVE_COMPARATOR

fluvastatin

Intervention Type DRUG

80 mg MR, 12 weeks

Fluvastatin + Ezetimibe

Fluvastatin MR 80 mg plus Ezetimibe 10 mg

Group Type ACTIVE_COMPARATOR

Fluvastatin plus ezetimibe

Intervention Type DRUG

fluvastatin 80 mg MR plus ezetimibe 10 mg

Interventions

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fluvastatin

80 mg MR, 12 weeks

Intervention Type DRUG

Fluvastatin plus ezetimibe

fluvastatin 80 mg MR plus ezetimibe 10 mg

Intervention Type DRUG

Other Intervention Names

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Lescol Lescol, Ezetrol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Graz

Principal Investigators

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Winfried März, Prof., M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Synlab Medizinisches Versorgungszentrum für Labordiagnostik Heidelberg

Locations

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Depart. of Internal Medicine, Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

References

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Stojakovic T, de Campo A, Scharnagl H, Sourij H, Schmolzer I, Wascher TC, Marz 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.

Reference Type DERIVED
PMID: 20067513 (View on PubMed)

Other Identifiers

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2004-002535-12

Identifier Type: -

Identifier Source: org_study_id