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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Treatments: Ezetimibe; Fluvastatin

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