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

This study has been completed.
Sponsor:
Information provided by:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00059657
First received: April 29, 2003
Last updated: May 17, 2006
Last verified: May 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, California
Glendale, California, United States
Los Angeles, California, United States
San Francisco, 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
Birmingham, United Kingdom
Bristol, United Kingdom
Dundee, United Kingdom
Hull, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Southhampton, United Kingdom
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00059657     History of Changes
Other Study ID Numbers: WFI 01-02
Study First Received: April 29, 2003
Last Updated: May 17, 2006
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

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

ClinicalTrials.gov processed this record on July 24, 2014