NCT00851500已完成2 期
A Trial of the Safety and Efficacy of K-604 for the Treatment of Atherosclerosis
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
- 210
- 主要终点
- Change from baseline in plaque composition over 6 months
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of K-604 for the treatment of atherosclerosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate carotid artery stenosis
排除标准
- •history of arteritis
- •heavily calcified plaque
- •uncontrolled hypertension
- •poorly controlled diabetes
- •hypercholesterolemia
研究组 & 干预措施
low dose K-604
Experimental
干预措施: K-604 (Drug)
high dose K-604
Experimental
干预措施: K-604 (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in plaque composition over 6 months
时间窗: 6 months
次要结局
- Change from baseline in plaque size over 6 months.(6 months)
研究者
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