Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-24 @ 6:03 PM
Study NCT ID:
NCT00685958
Status:
COMPLETED
Last Update Posted:
2009-10-02
First Post:
2008-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japanese Safety and Efficacy Study of Enoxaparin in Patients With Hip Fracture Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-01', 'studyFirstSubmitDate': '2008-05-26', 'studyFirstSubmitQcDate': '2008-05-26', 'lastUpdatePostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bleeding events', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'incidence of venous thromboembolism', 'timeFrame': '28 days'}]}, 'conditionsModule': {'keywords': ['Blood thinner', 'enoxaparin', 'hip fracture surgery', 'bleeding', 'thromboembolism'], 'conditions': ['Hip Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous blood clots in patients with hip fracture surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* femoral neck inside or outside fracture\n\nExclusion Criteria:\n\n* any major surgery on lower limbs within 3 months\n* clinical signs of deep vein thrombosis\n* use of non-steroidal anti-inflammatory drugs\n* severe hepatic disease or renal insufficiency'}, 'identificationModule': {'nctId': 'NCT00685958', 'briefTitle': 'Japanese Safety and Efficacy Study of Enoxaparin in Patients With Hip Fracture Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Multicenter, Non-comparative, Open-label Study to Evaluate the Safety and Efficacy of Enoxaparin Sodium (RP54563) 20 mg Bid for 14 Days in Patients With Hip Fracture Surgery', 'orgStudyIdInfo': {'id': 'SFY6771'}}, 'armsInterventionsModule': {'interventions': [{'name': 'enoxaparin (XRP4563)', 'type': 'DRUG', 'description': '14 days of treatment'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Sanofi- Aventis Administrative Office', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'International Clinical Development, Study Director', 'oldOrganization': 'sanofi-aventis'}}}}