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

May 17, 2006 updated by: Mitsubishi Tanabe Pharma Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom
      • Bristol, United Kingdom
      • Dundee, United Kingdom
      • Hull, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Southhampton, United Kingdom
  • United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Glendale, California, United States
      • Los Angeles, California, United States
      • San Francisco, California, United States
    • Florida
      • Pensacola, Florida, United States
    • Illinois
      • Springfield, Illinois, United States
    • Kansas
      • Shawnee Mission, Kansas, United States
    • Louisiana
      • Kenner, Louisiana, United States
    • Michigan
      • Royal Oak, Michigan, United States
    • Mississippi
      • Biloxi, Mississippi, United States
    • New York
      • Rochester, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Texas
      • San Antonio, Texas, United States
    • Washington
      • Tacoma, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction in proportion of subjects who die within 6 months from treatment initiation.
Reduction in the proportion of subjects who experience a major amputation.

Secondary Outcome Measures

Outcome Measure
Reduction in major amputation rate only.
Improvement in complete ulcer healing.
Improvement in pain at rest.
Improvement in quality of life.
Improvement in hemodynamic measurements.
Improvement in neuropathy.
Reduction in critical cardiovascular events (MI, stroke, CV death, etc.)
Improvement in graft patency of index operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

April 29, 2003

First Submitted That Met QC Criteria

May 1, 2003

First Posted (Estimate)

May 2, 2003

Study Record Updates

Last Update Posted (Estimate)

May 19, 2006

Last Update Submitted That Met QC Criteria

May 17, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WFI 01-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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