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临床试验/NCT00566267
NCT00566267已完成2 期

A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet

Merck Sharp & Dohme LLC0 个研究点目标入组 58 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
58
主要终点
LDL cholesterol

研究概览

简要总结

People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Statins may not be the most effective strategy for patients on this diet, since they typically consume a greater amount of saturated fat and cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We hypothesize that patients following a low carbohydrate diet would experience a significantly greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

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

  • Moderately obese with hyperlipidemia

排除标准

  • Recent unstable heart or lung condition
  • Current use of other lipid modifying drugs
  • Hepatic disease
  • Pregnancy or lactation

研究组 & 干预措施

2

Experimental

Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg

干预措施: simvastatin 20 mg/ezetimibe (Drug)

结局指标

主要结局

LDL cholesterol

时间窗: 8 weeks of treatment

次要结局

  • Other lipid measures(8 weeks of treatment)
  • Safety and tolerability(8 weeks treatment)

研究者

申办方类型
Industry

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