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Efficacy/safety of ecraprost in lipid emulsion for treatment of critical leg ischemia due to peripheral arterial disease

This study is currently recruiting patients.

Sponsored by: Mitsubishi Pharma Corporation
Information provided by: Mitsubishi Pharma Corporation

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 Treatment or Intervention Phase
Critical Limb Ischemia due to peripheral arterial disease
 Drug: Ecraprost in lipid emulsion
Phase III

MedlinePlus consumer health information 

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: 

Expected Total Enrollment:  280

Study start: August 2001;  Study completion: May 2004

Eligibility

Ages Eligible for Study:  40 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Exclusion Criteria:


Location and Contact Information

Clinical Solutions      1-888-216-4620 

Arizona
      Tucson,  Arizona,  United States; Recruiting

      Phoenix,  Arizona,  United States; Recruiting

California
      Los Angeles,  California,  United States; Recruiting

      San Francisco,  California,  United States; Recruiting

      Glendale,  California,  United States; Recruiting

Florida
      Pensacola,  Florida,  United States; Recruiting

Illinois
      Springfield,  Illinois,  United States; Recruiting

Kansas
      Shawnee Mission,  Kansas,  United States; Recruiting

Louisiana
      Kenner,  Louisiana,  United States; Recruiting

Michigan
      Royal Oak,  Michigan,  United States; Recruiting

Mississippi
      Biloxi,  Mississippi,  United States; Recruiting

New York
      Rochester,  New York,  United States; Recruiting

North Carolina
      Durham,  North Carolina,  United States; Recruiting

Texas
      San Antonio,  Texas,  United States; Recruiting

Washington
      Tacoma,  Washington,  United States; Recruiting

United Kingdom
      Hull,  United Kingdom; Recruiting

      London,  United Kingdom; Recruiting

      Birmingham,  United Kingdom; Recruiting

      Southhampton,  United Kingdom; Recruiting

      Dundee,  United Kingdom; Recruiting

      Bristol,  United Kingdom; Recruiting

      Manchester,  United Kingdom; Recruiting

More Information

Study ID Numbers:  WFI 01-02
Record last reviewed:  August 2003
Record first received:  April 29, 2003
ClinicalTrials.gov Identifier:  NCT00059657
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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