Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk

This study has been completed.
Sponsor:
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
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP [ Time Frame: week 6 and 12 ] [ Designated as safety issue: No ]
  • adverse events, CK elevation, liver enzyme elevation [ Time Frame: week 6, 12 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

No publications provided by Medical University of Graz

Additional 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
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fluvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014