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

This study has been terminated.

First Received on April 29, 2003. Last Updated on June 23, 2005 History of Changes

Sponsor:	Mitsubishi Tanabe Pharma Corporation
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00059644

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 III

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 for the Treatment of Critical Leg Ischemia

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Lipids Ecraprost

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

Reduction in 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.
Improvement in complete ulcer healing.
Improvement in pain at rest.
Improvement in quality of life.
Improvement in hemodynamic measurements.
Improvement in neuropathy.

Estimated Enrollment:	560
Study Start Date:	July 2001
Estimated Study Completion Date:	June 2004

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
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059644

Show 27 Study Locations

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00059644 History of Changes
Other Study ID Numbers:	WFI 01-01
Study First Received:	April 29, 2003
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Ecraprost in lipid emulsion
CLI
peripheral

vascular
amputation
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 February 09, 2012