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临床试验/NCT00299884
NCT00299884已完成不适用

The Comparison of the Efficacy of Ezetimibe and Fenofibrate Versus Atorvastatin Alone in the Lowering of LDL Cholesterol

Queen's University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
To examine the efficacy of a combination of ezetimibe and fenofibrate in comparison with that of atorvastatin in lowering LDL-C.

研究概览

简要总结

The primary aim of this study is to evaluate the efficacy and non-inferiority of a lipid-lowering medication regimen comprised of the medications ezetimibe and fenofibrate taken daily, versus atorvastatin daily in lowering levels of low-density lipoprotein (LDL-C) cholesterol. Additionally, other aims would include effects on other types of blood cholesterol and examining the safety of the ezetimibe and fenofibrate regimen, as compared to atorvastatin.

详细描述

It has been demonstrated in several previous primary and secondary studies that lowering low-density lipoprotein cholesterol (LDL-C) with the use of medications such as 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors improves mortality and morbidity related to cardiovascular events in patients with hypercholesterolemia. Such inhibitors, which are known as 'statins', act to block the synthesis of cholesterol in the liver. These medications are generally well tolerated by the vast majority of patients, but a small number experience side effects, most seriously those of myopathies, rhabdomyolysis and elevated liver enzymes - recognition of this fact, that statins are not universally without problems, highlights the need for viable alternatives.

Ezetimibe is a relatively new medication in Canada, approved for use in patients with cholesterol problems. It is an intestinal cholesterol binder that is known to be well-tolerated, with side effects similar to placebo. Alone, it has a modest effect in the lowering of LDL-C. Fenofibrate is a medication that also works through the liver and has long been used to adjust blood lipid levels in patients with mixed lipid problems. Alone it also has a modest effect in the lowering of LDL-C. Recent study, however, has shown that the effect of ezetimibe and fenofibrate together in the lowering of LDL-C is greater than that of either drug alone. This combination, if as effective in this regard as atorvastatin, would prove a valid alternative to the use of the atorvastatin in the lowering of LDL-C, and a benefit for patients who have had problems tolerating statin therapy but still require medication for elevated cholesterol.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Study is confined to subjects with elevated LDL-C levels 3.0 mmol/L and greater.

排除标准

  • Abnormal liver enzymes (ie, AST, ALT greater than three times the upper limit of normal);
  • Creatine kinase levels more than two times the upper limit of normal;
  • Uncontrolled ethanol use (this may affect compliance);
  • Pregnant or breastfeeding women or women not using adequate contraceptive methods;
  • Previous history of intolerance or adverse effects with statins;
  • Previous history of intolerance or adverse effects with fibric acid derivatives;
  • Previous history of intolerance or adverse effects with ezetimibe;
  • Uncontrolled diabetes (HbA1c > 10%);
  • Recent myocardial infarction (within 6 weeks);
  • Concurrent enrollment in another study.

研究组 & 干预措施

1

Lipitor 20 mg

干预措施: Lipitor 20 mg (Drug)

2

Lipidil Supra 160 mg and Ezetrol 10 mg

干预措施: Combination Ezetrol 10 mg and Lipidil Supra 160 mg (Drug)

结局指标

主要结局

To examine the efficacy of a combination of ezetimibe and fenofibrate in comparison with that of atorvastatin in lowering LDL-C.

时间窗: 12 weeks

次要结局

  • To examine the efficacy of a combination of ezetimibe and fenofibrate in comparison with that of atorvastatin in lowering triglyceride levels, raising HDL-C levels and lowering of hsCRP levels.(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Stephen LaHaye

Principal Investigator

Queen's University

研究点 (1)

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