Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease

Stopped early · Phase 3

Conditions studied: Peripheral Vascular Disease

In brief

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.

Key facts

Study ID

NCT00059644

Run by

Tanabe Pharma Corporation

People needed

560

Starts

2001-07-01

Expected to finish

2004-06-01

Last updated by the study team

2005-06-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Glendale, California, United States
• Study site — Los Angeles, California, United States
• Study site — Pasadena, California, United States
• Study site — San Francisco, California, United States
• Study site — Pensacola, Florida, United States
• Study site — Springfield, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Biloxi, Mississippi, United States
• Study site — Kansas City, Missouri, United States
• Study site — Henderson, Nevada, United States
• Study site — West Caldwell, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — San Antonio, Texas, United States
• Study site — Tacoma, Washington, United States
• Study site — Birmingham, United Kingdom
• Study site — Bristol, United Kingdom
• Study site — Dundee, United Kingdom
• Study site — Hull, United Kingdom
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.