NCT00814723

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	fluvastatin	80 mg MR, 12 weeks
DRUG	Fluvastatin plus ezetimibe	fluvastatin 80 mg MR plus ezetimibe 10 mg

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2008-12-25
• Last updated: 2008-12-25

Locations

1 site across 1 country: Austria