跳至主要内容
临床试验/NCT00408382
NCT00408382已完成4 期

Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque

Astellas Pharma Inc2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年12月6日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
2
主要终点
Changes in plaque characteristics as observed by coronary angioscopy

研究概览

简要总结

To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying coronary artery disease

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with hypercholesteremia
  • The indication of coronary angiography, coronary angioscopy and intravascular ultrasound are expected

排除标准

  • Patients who has current administration of Lipitor or history of discontinued administration of Lipitor
  • Acute cardiac infarction

结局指标

主要结局

Changes in plaque characteristics as observed by coronary angioscopy

(the amount of yellow plaque and grade shall be determined by the coronary angioscopic findings evaluation committee)

Changes in the volume and the echogenicity as observed by intravascular ultrasound

次要结局

  • Rate of change in serum lipid level
  • Changes in the surface character and size of plaque as observed by coronary angioscopy (determined by the angioscopic findings evaluation committee)

研究者

申办方类型
Industry

研究点 (2)

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