NCT00843661Unknown4 期
Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients Receiving Protease Inhibitors: a Randomized, Prospective, Controlled Pilot Study.
Ospedale di Circolo - Fondazione Macchi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- per cent changes of LDL cholesterol, comparison between the 2 treatment regimens
研究概览
简要总结
- The aim of the study is to compare the effects of coadministration of ezetimibe 10 mg/die + fenofibrate 200 mg/die versus pravastatin 40 mg/die monotherapy in HIV-infected patients treated with protease inhibitors.
- Single-centre, open, randomized, controlled, prospective pilot study.
- 60 patients will be enrolled in order to reach the target of 50 patients evaluable at the end of the study. The patients will be randomly assigned to a 6-month treatment with ezetimibe+fenofibrate or with pravastatin.The visit will be every month.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients older than 18 years
- •documented positive HIV antibodies test
- •on stable therapy with PIs for at least 12 months
- •LDL-cholesterol >130 mg/dl or triglycerides 200 - 500 mg/dl with non-HDL cholesterol >160 mg/dl
- •unresponsive to dietary measures and regular physical exercise of at
排除标准
- •history of dyslipidemia before antiretroviral therapy
- •cardiovascular and cerebrovascular diseases
- •Cushing's syndrome
- •concurrent therapy with lipid-lowering agents, oral anticoagulant, estrogens, thiazidic diuretics, beta-blockers
- •hypothyroidism
- •Type 1 diabetes mellitus
- •renal failure
研究组 & 干预措施
Ezetimibe and fenofibrate
Experimental
干预措施: ezetimibe (Drug)
Ezetimibe and fenofibrate
Experimental
干预措施: fenofibrate (Drug)
Pravastatin
Active Comparator
干预措施: pravastatin (Drug)
结局指标
主要结局
per cent changes of LDL cholesterol, comparison between the 2 treatment regimens
时间窗: After 6 month treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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