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

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Fluvastatin plus ezetimibe; Drug: fluvastatin

• Registration Number: NCT00814723
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-09
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2008-12
• Study First Submitted: 2008-12-24
• Study First Submitted QC: 2008-12-24
• Last Update Submitted: 2008-12-24
• Study First Posted: 2008-12-25
• Last Update Posted: 2008-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluvastatin + Ezetimibe	Fluvastatin plus ezetimibe	Fluvastatin MR 80 mg plus Ezetimibe 10 mg
Fluvastatin	fluvastatin	Fluvastatin 80 mg MR

Primary Outcome Measures

Name	Time	Method
Reduction in Low density lipoprotein cholesterol (LDL-C)	week 6 and 12

Secondary Outcome Measures

Name	Time	Method
Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP	week 6 and 12
adverse events, CK elevation, liver enzyme elevation	week 6, 12

Trial Locations

Locations (1)

Depart. of Internal Medicine, Medical University of Graz; 🇦🇹 Graz, Austria