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

NCT ID: NCT00059657

Last Updated: 2006-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Vascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ecraprost in lipid emulsion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Locations

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Southhampton, , United Kingdom

Site Status

Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Glendale, California, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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Pensacola, Florida, United States

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Springfield, Illinois, United States

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Shawnee Mission, Kansas, United States

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Kenner, Louisiana, United States

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Royal Oak, Michigan, United States

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Biloxi, Mississippi, United States

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Rochester, New York, United States

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Durham, North Carolina, United States

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San Antonio, Texas, United States

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Tacoma, Washington, United States

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Birmingham, , United Kingdom

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Bristol, , United Kingdom

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Dundee, , United Kingdom

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Hull, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Countries

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United States United Kingdom

Other Identifiers

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WFI 01-02

Identifier Type: -

Identifier Source: org_study_id