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临床试验/NCT00185146
NCT00185146已完成2 期

Effect of Pactimibe on the Progression of Atherosclerosis as Measured by 2-D and 3-D Carotid Ultrasound

Sankyo Pharma Gmbh1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2002年9月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
200
试验地点
1
主要终点
Efficacy of pactimibe versus placebo on the progression of atherosclerosis

研究概览

简要总结

The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound

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
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Increased cardiovascular risk (i.e. history of myocardial infarction, stroke, diabetes mellitus, left ventricular hypertrophy)
  • Intima-media thickness greater than or equal to 0.8 mm as measured by ultrasonography
  • Negative pregnancy test for females

排除标准

  • Whole blood donation (greater than or equal to 450 ml) during the last three months before study start
  • Unstable angina, congestive heart failure or uncontrolled hypertension
  • Renal disease including nephrectomy and/or renal transplant
  • Hepatic disease or abnormal liver function parameters
  • Drug abuse or alcohol addiction

结局指标

主要结局

Efficacy of pactimibe versus placebo on the progression of atherosclerosis

次要结局

  • Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis

研究者

申办方类型
Industry

研究点 (1)

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