Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 24, 2008
CompletedFirst Posted
Study publicly available on registry
December 25, 2008
CompletedDecember 25, 2008
December 1, 2008
2 years
December 24, 2008
December 24, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in Low density lipoprotein cholesterol (LDL-C)
week 6 and 12
Secondary Outcomes (2)
Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP
week 6 and 12
adverse events, CK elevation, liver enzyme elevation
week 6, 12
Study Arms (2)
Fluvastatin
ACTIVE COMPARATORFluvastatin 80 mg MR
Fluvastatin + Ezetimibe
ACTIVE COMPARATORFluvastatin MR 80 mg plus Ezetimibe 10 mg
Interventions
fluvastatin 80 mg MR plus ezetimibe 10 mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Depart. of Internal Medicine, Medical University of Graz
Graz, 8036, Austria
Related Publications (1)
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.
PMID: 20067513DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Winfried März, Prof., M.D.
Medical University of Graz, Synlab Medizinisches Versorgungszentrum für Labordiagnostik Heidelberg
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 24, 2008
First Posted
December 25, 2008
Study Start
September 1, 2005
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
December 25, 2008
Record last verified: 2008-12