Safety and Efficacy pf Propionyl-L-Carnitine in Combination With Monitored Exercise Training in Peripheral Arterial Disease (Intermittent Claudication).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 9
- 主要终点
- Peak walking time
研究概览
简要总结
Patients with peripheral artery disease have decreased blood flow to exercising muscle causing pain. This decreased blood flow to the muscle affects the level of acylcarnitines which in turn decreases the level of carnitine. Carnitine allows muscles to function properly. This study will test the safety and efficacy of Propionyl-L-Carnitine taken in combination with a monitored exercise training program.
详细描述
To test the hypothesis that Propionyl-L-Carnitine taken in combination with monitored exercise training may improve exercise performance the study will randomize male or female adults with peripheral artery disease and claudication to receive either Proprionyl-L-Carnitine or Placebo.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory outpatient who are able to exercise
- •Intermittent claudication due to peripheral artery disease
- •Willingness to participate in a monitored exercise training program
排除标准
- •Pain at rest, ischemic ulcerations, gangrene of the lower extremity
- •Peripheral Artery Disease of a non-atherosclerotic nature
- •Any disease process other than PAD, that may interfere with performance during the treadmill test or prevent the subject from reaching their claudication-limited PWT
- •Current participation in an exercise training program or previous participtation in a monitored exercise training program within 6 months of the screening visit.
研究组 & 干预措施
PLC
Investigational drug
干预措施: Propionyl-L-Carnitine (Drug)
PLC
Investigational drug
干预措施: PLC (Drug)
Placebo
干预措施: Propionyl-L-Carnitine (Drug)
Placebo
干预措施: PLC (Drug)
结局指标
主要结局
Peak walking time
时间窗: 6 months
次要结局
- Claudication onset time, activity level and quality of life(6 months)