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

Primary Purpose

Peripheral Vascular Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ecraprost in lipid emulsion
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring Ecraprost in lipid emulsion, CLI, peripheral, vascular, amputation, Angioplasty, by-pass, Critical Limb Ischemia due to peripheral arterial disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2003
Last Updated
May 17, 2006
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00059657
Brief Title
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease
Keywords
Ecraprost in lipid emulsion, CLI, peripheral, vascular, amputation, Angioplasty, by-pass, Critical Limb Ischemia due to peripheral arterial disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
280 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ecraprost in lipid emulsion
Primary Outcome Measure Information:
Title
Reduction in the proportion of subjects who experience a major amputation.
Title
Reduction in proportion of subjects who die within 6 months from treatment initiation.
Secondary Outcome Measure Information:
Title
Reduction in major amputation rate only.
Title
Reduction in critical cardiovascular events (MI, stroke, CV death, etc.)
Title
Improvement in graft patency of index operation.
Title
Improvement in complete ulcer healing.
Title
Improvement in pain at rest.
Title
Improvement in quality of life.
Title
Improvement in hemodynamic measurements.
Title
Improvement in neuropathy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Glendale
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Pensacola
State/Province
Florida
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
Shawnee Mission
State/Province
Kansas
Country
United States
City
Kenner
State/Province
Louisiana
Country
United States
City
Royal Oak
State/Province
Michigan
Country
United States
City
Biloxi
State/Province
Mississippi
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Tacoma
State/Province
Washington
Country
United States
City
Birmingham
Country
United Kingdom
City
Bristol
Country
United Kingdom
City
Dundee
Country
United Kingdom
City
Hull
Country
United Kingdom
City
London
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Southhampton
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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