NCT00068133已完成2 期
A Phase II Multicenter, Double-Blind, Placebo-Controlled, Trial of VLTS-589 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Valentis
- 入组人数
- 100
- 试验地点
- 39
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of VLTS-589 compared with placebo, administered bilaterally to the lower extremities, in subjects with intermittent claudication and to determine the effect of VLTS-589 in peak walking time (PWT) for subjects receiving VLTS-589 compared with subjects receiving placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women between 40 and 80 years of age,
- •Must give informed consent,
- •Current medical history of peripheral arterial disease, which includes the following symptoms: leg pain, leg discomfort or leg weakness
排除标准
- •Ulcers or gangrene,
- •History of cancer (except skin cancer) within the past 5 years,
- •Participation in another clinical trial within 30 days of enrollment in this trial,
- •Unwillingness or inability to comply with all study requirements
研究者
研究点 (39)
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