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临床试验/NCT00349284
NCT00349284已完成3 期

A Randomised, Double-Blind Study Comparing the Efficacy and Safety of 145 mg Fenofibrate, 10 mg Ezetimibe and Their Combination in Patients With Type IIb Dyslipidemia and Features of the Metabolic Syndrome

Solvay Pharmaceuticals52 个研究点 分布在 3 个国家目标入组 181 人开始时间: 2005年1月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
181
试验地点
52
主要终点
TG and HDL-C levels.

研究概览

简要总结

Type IIb dyslipidemia is characterized by elevated triglycerides (TG ³ 150 mg/dL), and elevated LDL-C levels (³160 mg/dL). When in addition, HDL-C is low, the presence of the lipid triad, elevated TG and LDL-C and low levels of HDL-C, seems to confer additional CHD risk in this type of patient, compared to elevated LDL-C alone.Coadministration of fenofibrate and ezetimibe could provide a complementary efficacy therapy and improve the atherogenic profile of this patient population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type IIb dyslipidemia.

排除标准

  • Known hypersensitivity to fibrates or ezetimibe. Pregnant or lactating women. Contra-indication to fenofibrate or ezetimibe.

结局指标

主要结局

TG and HDL-C levels.

次要结局

未报告次要终点

研究者

申办方类型
Industry

研究点 (52)

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