Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-28 @ 3:44 AM
Study NCT ID:
NCT00059657
Status:
COMPLETED
Last Update Posted:
2006-05-19
First Post:
2003-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C110507', 'term': 'Ecraprost'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'statusVerifiedDate': '2006-05', 'completionDateStruct': {'date': '2005-11'}, 'lastUpdateSubmitDate': '2006-05-17', 'studyFirstSubmitDate': '2003-04-29', 'studyFirstSubmitQcDate': '2003-05-01', 'lastUpdatePostDateStruct': {'date': '2006-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the proportion of subjects who experience a major amputation.'}, {'measure': 'Reduction in proportion of subjects who die within 6 months from treatment initiation.'}], 'secondaryOutcomes': [{'measure': 'Reduction in major amputation rate only.'}, {'measure': 'Reduction in critical cardiovascular events (MI, stroke, CV death, etc.)'}, {'measure': 'Improvement in graft patency of index operation.'}, {'measure': 'Improvement in complete ulcer healing.'}, {'measure': 'Improvement in pain at rest.'}, {'measure': 'Improvement in quality of life.'}, {'measure': 'Improvement in hemodynamic measurements.'}, {'measure': 'Improvement in neuropathy.'}]}, 'conditionsModule': {'keywords': ['Ecraprost in lipid emulsion', 'CLI', 'peripheral, vascular', 'amputation', 'Angioplasty', 'by-pass', 'Critical Limb Ischemia due to peripheral arterial disease'], 'conditions': ['Peripheral Vascular Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* 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.\n\nExclusion Criteria:\n\n* Subjects with a previous major amputation (at or above ankle)\n* 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.'}, 'identificationModule': {'nctId': 'NCT00059657', 'briefTitle': 'Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'WFI 01-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ecraprost in lipid emulsion', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Glendale', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'city': 'Shawnee Mission', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.02, 'lon': -94.66583}}, {'city': 'Kenner', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.99409, 'lon': -90.24174}}, {'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'city': 'Biloxi', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 30.39603, 'lon': -88.88531}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Bristol', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Dundee', 'country': 'United Kingdom', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'city': 'Hull', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Southhampton', 'country': 'United Kingdom'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}}}}