NCT00783081已完成2 期
Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication
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
- 387
- 主要终点
- Improvement in peak walking time at 26 weeks
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable claudication symptoms
排除标准
- •Lower extremity amputation
- •Signs or symptoms of critical leg ischemia (CLI)
- •Uncontrolled hypertension
- •Tachycardia
- •Poorly controlled diabetes
- •Hypercholesterolemia
研究组 & 干预措施
low dose K-134
Experimental
干预措施: K-134 (Drug)
mid dose K-134
Experimental
干预措施: K-134 (Drug)
high dose K-134
Experimental
干预措施: K-134 (Drug)
Comparator
Active Comparator
干预措施: Cilostazol 100 mg BID (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in peak walking time at 26 weeks
时间窗: 26 Weeks
次要结局
- Improvement in claudication onset time at 26 weeks(26 Weeks)
研究者
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