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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814723
• Other study ID #: 2004-002535-12
• Status: Completed
• Phase: Phase 4
• First received: December 24, 2008
• Last updated: December 24, 2008
• Start date: September 2005
• Est. completion date: September 2007

Study information

• Verified date: December 2008
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• fluvastatin
80 mg MR, 12 weeks
• Fluvastatin plus ezetimibe
fluvastatin 80 mg MR plus ezetimibe 10 mg

Locations

Country	Name	City	State
Austria	Depart. of Internal Medicine, Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Low density lipoprotein cholesterol (LDL-C)		week 6 and 12	No
Secondary	Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP		week 6 and 12	No
Secondary	adverse events, CK elevation, liver enzyme elevation		week 6, 12	Yes