Fluvastatin 80 mg ret. vs combination with ezetimib 10 mg

Phase 1

• Conditions: elevated LDL-C

• Registration Number: EUCTR2004-002535-12-AT
• Lead Sponsor: Clinical Institute of Medical and Chemical Laboratory Diagnostics Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-15
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·CHD Stage III-IV
·St. p. myocardial infarction or coronary artery bypass grafting
·Pregnancy or breastfeeding
·AST or ALT > 3x ULN (upper limit of normal)
·CPK > 5x ULN or > 3x with muscle pain, tenderness or weakness
·Severe renal dysfunction, nephritic syndrome
·Premenopausal women without certain contraception
·Known hypersensitivity to HMG-CoA reductase inhibitors or ezetimib

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. Fluvastatin and ezetimib are generally well tolerated.;Secondary Objective: ;Primary end point(s): Low density lipoprotein cholesterol (LDL-C)