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

Mitsubishi Tanabe Pharma

Status and phase

Completed

Phase 3

Conditions

Peripheral Vascular Disease

Treatments

Drug: Ecraprost in lipid emulsion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00059657

WFI 01-02

Details and patient eligibility

About

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.

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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
Subjects will already be scheduled to receive a revascularization procedure (e.g., by-pass graft, endovascular procedure, etc.) involving a distal target artery below the knee joint (e.g., below the knee joint popliteal, anterior/posterior tibial, peroneal, plantar, pedal, etc.) as part of their normal standard of care.

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.