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

Sponsored by:	Mitsubishi Tanabe Pharma Corporation
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00059657

Purpose

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.

Condition	Intervention	Phase
Peripheral Vascular Disease	Drug: Ecraprost in lipid emulsion	Phase III

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

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.

Estimated Enrollment:	280
Study Start Date:	August 2001
Estimated Study Completion Date:	November 2005

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059657

Locations

United States, Arizona

Tucson, Arizona, United States

Phoenix, Arizona, United States
United States, California

Los Angeles, California, United States

San Francisco, California, United States

Glendale, California, United States
United States, Florida

Pensacola, Florida, United States
United States, Illinois

Springfield, Illinois, United States
United States, Kansas

Shawnee Mission, Kansas, United States
United States, Louisiana

Kenner, Louisiana, United States
United States, Michigan

Royal Oak, Michigan, United States
United States, Mississippi

Biloxi, Mississippi, United States
United States, New York

Rochester, New York, United States
United States, North Carolina

Durham, North Carolina, United States
United States, Texas

San Antonio, Texas, United States
United States, Washington

Tacoma, Washington, United States
United Kingdom

Hull, United Kingdom

London, United Kingdom

Manchester, United Kingdom

Southhampton, United Kingdom

Dundee, United Kingdom

Bristol, United Kingdom

Birmingham, United Kingdom

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

More Information

Study ID Numbers:	WFI 01-02
Study First Received:	April 29, 2003
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00059657
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Ecraprost in lipid emulsion
CLI
peripheral, vascular
amputation

Angioplasty
by-pass
Critical Limb Ischemia due to peripheral arterial disease

Study placed in the following topic categories:

Peripheral Vascular Diseases
Vascular Diseases
Ischemia

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009