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Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk
This study has been completed.
Sponsor:
Medical University of Graz
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00814723
First received: December 24, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Hypercholesterolemia | Drug: fluvastatin Drug: Fluvastatin plus ezetimibe | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk |
Resource links provided by NLM:
Further study details as provided by Medical University of Graz:
Primary Outcome Measures:
- Reduction in Low density lipoprotein cholesterol (LDL-C) [ Time Frame: week 6 and 12 ]
Secondary Outcome Measures:
- Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP [ Time Frame: week 6 and 12 ]
- adverse events, CK elevation, liver enzyme elevation [ Time Frame: week 6, 12 ]
| Enrollment: | 90 |
| Study Start Date: | September 2005 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Fluvastatin
Fluvastatin 80 mg MR
|
Drug: fluvastatin
80 mg MR, 12 weeks
Other Name: Lescol
|
|
Active Comparator: Fluvastatin + Ezetimibe
Fluvastatin MR 80 mg plus Ezetimibe 10 mg
|
Drug: Fluvastatin plus ezetimibe
fluvastatin 80 mg MR plus ezetimibe 10 mg
Other Name: Lescol, Ezetrol
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814723
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814723
Locations
| Austria | |
| Depart. of Internal Medicine, Medical University of Graz | |
| Graz, Austria, 8036 | |
Sponsors and Collaborators
Medical University of Graz
Investigators
| Principal Investigator: | Winfried März, Prof. , M.D. | Medical University of Graz, Synlab Medizinisches Versorgungszentrum für Labordiagnostik Heidelberg |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Dr. Winfried März, Medical University of Graz |
| ClinicalTrials.gov Identifier: | NCT00814723 History of Changes |
| Other Study ID Numbers: |
2004-002535-12 |
| Study First Received: | December 24, 2008 |
| Last Updated: | December 24, 2008 |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Fluvastatin Ezetimibe |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 27, 2017