Status:
COMPLETED
Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk
Lead Sponsor:
Medical University of Graz
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 facto...
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 incide...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00814723
Start Date
September 1 2005
End Date
September 1 2007
Last Update
December 25 2008
Active Locations (1)
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1
Depart. of Internal Medicine, Medical University of Graz
Graz, Austria, 8036