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



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

For Condition: Critical Limb Ischemia due to peripheral arterial disease
Status: Terminated
Sponsor(s): Mitsubishi Pharma Corporation ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 40 Years/
Genders: Both
Protocol Entry 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 - 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.
Total Enrollment: 560

Location and Contact Information:


Additional Information:
Study ID Numbers:
  WFI 01-01; 
Study Start Date: July 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059644

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

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