elevated LDL-C
Conditions
Interventions
Trade Name: Lescol
Product Name: Lescol MR 80 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Fluvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
T
Sponsors
Clinical Institute of Medical and Chemical Laboratory Diagnostics Graz
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Austria
Outcome results
None listed