Multicenter,Double Blind,Randomized, 2-period, Crossover Study to Compare Ezetimibe/Simvastatin (10mg/10 mg) Combination Tablet Versus Simvastatin 80mg Tablet on Postprandial Arterial Endothelial Function in Patients With Metabolic Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Treatment Difference in (Postprandial-Fasting) FMD
研究概览
简要总结
The purpose of this study is to investigate whether low-dose simvastatin in combination with ezetimibe in comparison to high-dose simvastatin alone, has a beneficial effect on the function of the endothelium after an oral fat load in patients with metabolic syndrome.
详细描述
Metabolic syndrome is defined as a group of cardiovascular risk factors and is mainly driven by the epidemic of obesity. High blood lipid levels after a meal may be an important risk factor for cardiovascular disease. In this study we will investigate whether simvastatin in combination with ezetimibe vs. simvastatin alone, has a beneficial effect on the lipid levels after a meal, but more importantly, whether we can measure a difference in function of the endothelium. In a small pilot study we already found that the combination had a beneficial effect in comparison with simvastatin alone. Now we want to solidify these findings in a larger study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
First Simva 80mg then Simvai/Eze10/10mg
First 6 weeks of Simvastatin 80mg, then 6 weeks of Simvastatin/Ezetimibe 10/10mg after 6 weeks of placebo washout
干预措施: Simvastatin (Drug)
First Simva 80mg then Simvai/Eze10/10mg
First 6 weeks of Simvastatin 80mg, then 6 weeks of Simvastatin/Ezetimibe 10/10mg after 6 weeks of placebo washout
干预措施: Simvastatin/Ezetimibe (Drug)
First Simva/Eze 10/10mg then Simva 80mg
First 6 weeks of Simvastatin/Ezetimibe 10/10mg, then 6 weeks of Simvastatin 80mg after 6 weeks of placebo washout
干预措施: Simvastatin (Drug)
First Simva/Eze 10/10mg then Simva 80mg
First 6 weeks of Simvastatin/Ezetimibe 10/10mg, then 6 weeks of Simvastatin 80mg after 6 weeks of placebo washout
干预措施: Simvastatin/Ezetimibe (Drug)
结局指标
主要结局
Treatment Difference in (Postprandial-Fasting) FMD
时间窗: After 6 weeks of treatment
A comparison of the postprandial minus fasting change in FMD under treatment with simvastatin 80 mg versus simvastatin 10/10 mg
次要结局
- Postprandial Endopat Measurement(after 6 weeks of treatment (crossover))
- Preprandial Endothelial Function Measured by FMD(after 6 weeks of treatment (crossover))
- Preprandial Endopat Measurement(after 6 weeks of treatment (crossover))
研究者
dr.Frank L.J. Visseren
Professor F.L.J. Visseren, MD PhD, head of department of Vascular Medicine
UMC Utrecht