Back to resultsFluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
fluvastatin
Fluvastatin plus ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility 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
Sites / Locations
- Depart. of Internal Medicine, Medical University of Graz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fluvastatin
Fluvastatin + Ezetimibe
Arm Description
Fluvastatin 80 mg MR
Fluvastatin MR 80 mg plus Ezetimibe 10 mg
Outcomes
Primary Outcome Measures
Reduction in Low density lipoprotein cholesterol (LDL-C)
Secondary Outcome Measures
Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP
adverse events, CK elevation, liver enzyme elevation
Full Information
NCT ID
NCT00814723
First Posted
December 24, 2008
Last Updated
December 24, 2008
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT00814723
Brief Title
Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk
Official Title
Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Graz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluvastatin
Arm Type
Active Comparator
Arm Description
Fluvastatin 80 mg MR
Arm Title
Fluvastatin + Ezetimibe
Arm Type
Active Comparator
Arm Description
Fluvastatin MR 80 mg plus Ezetimibe 10 mg
Intervention Type
Drug
Intervention Name(s)
fluvastatin
Other Intervention Name(s)
Lescol
Intervention Description
80 mg MR, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Fluvastatin plus ezetimibe
Other Intervention Name(s)
Lescol, Ezetrol
Intervention Description
fluvastatin 80 mg MR plus ezetimibe 10 mg
Primary Outcome Measure Information:
Title
Reduction in Low density lipoprotein cholesterol (LDL-C)
Time Frame
week 6 and 12
Secondary Outcome Measure Information:
Title
Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP
Time Frame
week 6 and 12
Title
adverse events, CK elevation, liver enzyme elevation
Time Frame
week 6, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried März, Prof., M.D.
Organizational Affiliation
Medical University of Graz, Synlab Medizinisches Versorgungszentrum für Labordiagnostik Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depart. of Internal Medicine, Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
20067513
Citation
Stojakovic T, de Campo A, Scharnagl H, Sourij H, Schmolzer I, Wascher TC, Marz W. Differential effects of fluvastatin alone or in combination with ezetimibe on lipoprotein subfractions in patients at high risk of coronary events. Eur J Clin Invest. 2010 Mar;40(3):187-94. doi: 10.1111/j.1365-2362.2009.02249.x. Epub 2010 Jan 7.
Results Reference
derived
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Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk
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