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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00059644
Recruitment Status : Terminated
First Posted : May 2, 2003
Last Update Posted : June 24, 2005
Information provided by:
Mitsubishi Tanabe Pharma Corporation

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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Drug: Ecraprost in lipid emulsion Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : July 2001
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Reduction in proportion of subjects who experience a major amputation.
  2. Reduction in proportion of subjects who die within 6 months from treatment initiation.

Secondary Outcome Measures :
  1. Reduction in major amputation rate only.
  2. Reduction in critical cardiovascular events.
  3. Improvement in complete ulcer healing.
  4. Improvement in pain at rest.
  5. Improvement in quality of life.
  6. Improvement in hemodynamic measurements.
  7. Improvement in neuropathy.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00059644

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Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation Identifier: NCT00059644     History of Changes
Other Study ID Numbers: WFI 01-01
First Posted: May 2, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2005

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Ecraprost in lipid emulsion
Critical Limb Ischemia due to peripheral arterial disease

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases