Back to resultsEfficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Primary Purpose
Peripheral Vascular Disease
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ecraprost in lipid emulsion
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring Ecraprost in lipid emulsion, CLI, peripheral, vascular, amputation, Critical Limb Ischemia due to peripheral arterial disease
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 The subject has exhausted all standard revascularization treatment options at this time. 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 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.
Improvement in complete ulcer healing.
Improvement in pain at rest.
Improvement in quality of life.
Improvement in hemodynamic measurements.
Improvement in neuropathy.
Full Information
NCT ID
NCT00059644
First Posted
April 29, 2003
Last Updated
June 23, 2005
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00059644
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 for the Treatment of Critical Leg Ischemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Terminated
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (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, 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
560 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ecraprost in lipid emulsion
Primary Outcome Measure Information:
Title
Reduction in 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.
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
The subject has exhausted all standard revascularization treatment options at this time.
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
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Los Angeles
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California
Country
United States
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Pasadena
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California
Country
United States
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San Francisco
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California
Country
United States
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Pensacola
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Florida
Country
United States
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Springfield
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Illinois
Country
United States
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Indianapolis
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Indiana
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United States
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New Orleans
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Louisiana
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United States
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Royal Oak
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Michigan
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United States
City
Biloxi
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Mississippi
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United States
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Kansas City
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Missouri
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United States
City
Henderson
State/Province
Nevada
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United States
City
West Caldwell
State/Province
New Jersey
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United States
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New York
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New York
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United States
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Charlotte
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North Carolina
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United States
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Portland
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Oregon
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United States
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San Antonio
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Texas
Country
United States
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Tacoma
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Washington
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United States
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Birmingham
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United Kingdom
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Bristol
Country
United Kingdom
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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
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Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
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