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Completed

NCT Number: NCT00814723

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Depart. of Internal Medicine, Medical University of Graz

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluvastatin

Drug

80 mg MR, 12 weeks

Other names: Lescol

Fluvastatin plus ezetimibe

Drug

fluvastatin 80 mg MR plus ezetimibe 10 mg

Other names: Lescol, Ezetrol

Primary outcomes

  1. Reduction in Low density lipoprotein cholesterol (LDL-C)

    Time frame: week 6 and 12

Secondary outcomes

  1. Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP

    Time frame: week 6 and 12

  2. adverse events, CK elevation, liver enzyme elevation

    Time frame: week 6, 12

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 25, 2008
Registry last updated
Dec 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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