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

Peripheral Vascular Disease Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of CirculaseTM in Conjunction With Peripheral Revascularization for the Treatment of Critical Leg Ischemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059657
• Other study ID #: WFI 01-02
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2003
• Last updated: May 17, 2006
• Start date: August 2001
• Est. completion date: November 2005

Study information

• Verified date: May 2006
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• Ecraprost in lipid emulsion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the proportion of subjects who experience a major amputation.
Primary	Reduction in proportion of subjects who die within 6 months from treatment initiation.
Secondary	Reduction in major amputation rate only.
Secondary	Reduction in critical cardiovascular events (MI, stroke, CV death, etc.)
Secondary	Improvement in graft patency of index operation.
Secondary	Improvement in complete ulcer healing.
Secondary	Improvement in pain at rest.
Secondary	Improvement in quality of life.
Secondary	Improvement in hemodynamic measurements.
Secondary	Improvement in neuropathy.