A Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NM-702 in Subjects With Intermittent Claudication
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 390
- 试验地点
- 18
- 主要终点
- Improvement in peak walking time at 24 weeks
研究概览
简要总结
NM-702 oral tablets are being developed for the treatment of Intermittent Claudication, a primary early stage indication of peripheral arterial disease (PAD). This trial is designed to assess the safety and efficacy of 4 mg and/or 8 mg NM-702 taken twice a day (BID) for 24 weeks to see if it improves peak walking time (PWT) more than placebo for the treatment of Intermittent Claudication.
详细描述
NM-702 oral tablets are being developed for the treatment of Intermittent Claudication, a primary early stage indication of peripheral arterial disease (PAD). This trial is designed to assess the safety and efficacy of 4 mg and/or 8 mg NM-702 BID for 24 weeks to see if it improves peak walking time (PWT) more than placebo 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
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable, symptomatic, intermittent claudication due to occlusive atherosclerotic disease of the lower extremities
- •Median treadmill peak walking time between 90 and 600 seconds
排除标准
- •Symptoms of limb threatening ischemia (ischemic rest pain, ischemic ulceration and/or gangrene)
- •Clinically significant pulmonary, neurological or skeletal dysfunction (e.g., lumbar canal stenosis, emphysema, uncontrolled angina, multiple sclerosis, or gait altering amputation) that would directly interfere or limit exercise testing
- •Subjects who have had, or will require, a peripheral revascularization procedure within 12 weeks prior to or following treatment initiation.
- •A resting blood pressure greater than 150/100 and other clinically significant results.
结局指标
主要结局
Improvement in peak walking time at 24 weeks
次要结局
- Improvement in claudication onset time at 24 weeks
- Health status survey questionnaire
- Walking impairment questionnaire