NCT00059644终止3 期
A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of CirculaseTM for the Treatment of Critical Leg Ischemia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 560
- 试验地点
- 27
- 主要终点
- Reduction in proportion of subjects who experience a major amputation.
研究概览
简要总结
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD). This trial is designed to assess the efficacy and safety of the drug in the treatment of CLI.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critical leg ischemia (CLI) defined as distal extremity pain at rest, or peripheral ischemic ulcer(s), with severe hemodynamic impairment as diagnosed by ankle systolic pressure, toe systolic pressure or TcPO2
- •The subject has exhausted all standard revascularization treatment options at this time.
排除标准
- •Subjects with a previous major amputation (at or above ankle)
- •Subjects with end stage renal disease (ESRD) defined as significant renal dysfunction evidenced by estimated creatinine clearance of < 20 cc/min, or receiving chronic hemodialysis therapy.
结局指标
主要结局
Reduction in proportion of subjects who experience a major amputation.
Reduction in proportion of subjects who die within 6 months from treatment initiation.
次要结局
- Improvement in pain at rest.
- Improvement in quality of life.
- Improvement in hemodynamic measurements.
- Improvement in neuropathy.
- Reduction in major amputation rate only.
- Reduction in critical cardiovascular events.
- Improvement in complete ulcer healing.
研究者
研究点 (27)
Loading locations...
相似试验
已完成
3 期
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial DiseasePeripheral Vascular DiseaseNCT00059657Tanabe Pharma Corporation280
已完成
3 期
Randomized, double-blind, placebo-controlled study of AMG0001(HGF plasmid) for patients with arteriosclerosis obliteransArteriosclerosis obliteransJPRN-UMIN000000730Anges MG, Inc.120
尚未招募
3 期
A Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative AgentHypovolemic ShockNCT05251181Pharmazz, Inc.430
已完成
2 期
A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)EdemaHeart Failure, CongestiveNCT00234104Otsuka Pharmaceutical Co., Ltd.122
已完成
不适用
A Trial of Ischemic Preconditioning in Raynaud's Phenomenon (RP)Raynaud's PhenomenonRaynaud DiseaseNCT02506062Lawson Health Research Institute21