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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 29, 2003
Last Updated Date	May 17, 2006
Start Date ^ICMJE	August 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Reduction in the proportion of subjects who experience a major amputation. Reduction in proportion of subjects who die within 6 months from treatment initiation.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00059657 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Peripheral Vascular Disease
Intervention ^ICMJE	Drug: Ecraprost in lipid emulsion
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	280
Completion Date	November 2005
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00059657
Other Study ID Numbers ^ICMJE	WFI 01-02
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Mitsubishi Tanabe Pharma Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mitsubishi Tanabe Pharma Corporation
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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