Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Phase 3
Terminated
- Conditions
- Peripheral Vascular Disease
- Registration Number
- NCT00059644
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 560
Inclusion Criteria
- 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.
Read More
Exclusion Criteria
- 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.
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduction in proportion of subjects who experience a major amputation. Reduction in proportion of subjects who die within 6 months from treatment initiation.
- Secondary Outcome Measures
Name Time Method Reduction in major amputation rate only. Reduction in critical cardiovascular events. Improvement in complete ulcer healing. Improvement in pain at rest. Improvement in quality of life. Improvement in hemodynamic measurements. Improvement in neuropathy.