Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00814723 |
Recruitment Status :
Completed
First Posted : December 25, 2008
Last Update Posted : December 25, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesterolemia | Drug: fluvastatin Drug: Fluvastatin plus ezetimibe | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | September 2007 |

Arm | Intervention/treatment |
---|---|
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 |
- Reduction in Low density lipoprotein cholesterol (LDL-C) [ Time Frame: week 6 and 12 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814723
Austria | |
Depart. of Internal Medicine, Medical University of Graz | |
Graz, Austria, 8036 |
Principal Investigator: | Winfried März, Prof., M.D. | Medical University of Graz, Synlab Medizinisches Versorgungszentrum für Labordiagnostik Heidelberg |
Responsible Party: | Prof. Dr. Winfried März, Medical University of Graz |
ClinicalTrials.gov Identifier: | NCT00814723 |
Other Study ID Numbers: |
2004-002535-12 |
First Posted: | December 25, 2008 Key Record Dates |
Last Update Posted: | December 25, 2008 |
Last Verified: | December 2008 |
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Ezetimibe |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |