Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-12 @ 12:07 PM
Study NCT ID:
NCT00913120
Status:
COMPLETED
Last Update Posted:
2010-06-09
First Post:
2009-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 610}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-08', 'studyFirstSubmitDate': '2009-06-02', 'studyFirstSubmitQcDate': '2009-06-02', 'lastUpdatePostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall incidence of venous thromboembolism', 'timeFrame': 'For 2 weeks'}], 'secondaryOutcomes': [{'measure': 'Incidence of individual venous thromboembolism', 'timeFrame': 'For 2 weeks'}, {'measure': 'Incidence of bleeding events', 'timeFrame': 'For 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['YM150', 'FXa inhibitor', 'Thrombosis', 'Anticoagulant', 'Venous thromboembolism', 'Arthroplasty, replacement, hip'], 'conditions': ['Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total hip replacement surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects is scheduled for elective primary total hip replacement surgery\n* Written informed consent obtained before screening\n\nExclusion Criteria:\n\n* Subject has history of deep vein thrombosis and/or pulmonary embolism\n* Subject has a hemorrhagic disorder and/or coagulation disorder\n* Subject has had clinically important bleeding occurred within 90 days prior to the screening visit\n* Subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia\n* Subject is receiving anticoagulants/antiplatelet agents'}, 'identificationModule': {'nctId': 'NCT00913120', 'briefTitle': 'Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Hip Replacement Surgery', 'orgStudyIdInfo': {'id': '150-CL-027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YM150 group-1', 'description': 'YM150 low dose group', 'interventionNames': ['Drug: YM150']}, {'type': 'EXPERIMENTAL', 'label': 'YM150 group-2', 'description': 'YM150 high dose group', 'interventionNames': ['Drug: YM150']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enoxaparin group', 'interventionNames': ['Drug: Enoxaparin']}], 'interventions': [{'name': 'YM150', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['YM150 group-1', 'YM150 group-2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['Placebo group']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'description': 'injection', 'armGroupLabels': ['Enoxaparin group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan'}, {'city': 'Chūbu', 'country': 'Japan', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokkaido', 'country': 'Japan'}, {'city': 'Kansai', 'country': 'Japan'}, {'city': 'Kantou', 'country': 'Japan'}, {'city': 'Kyusyu', 'country': 'Japan'}, {'city': 'Shikoku', 'country': 'Japan'}, {'city': 'Tōhoku', 'country': 'Japan', 'geoPoint': {'lat': 44.62026, 'lon': 142.29986}}, {'city': 'Daegu', 'country': 'South Korea', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Jeonnam', 'country': 'South Korea'}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Changhua', 'country': 'Taiwan', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'city': 'Chiayi City', 'country': 'Taiwan', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}, {'city': 'Taichung', 'country': 'Taiwan', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Chiang Mai', 'country': 'Thailand', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director', 'oldOrganization': 'Astellas Pharma, Inc'}}}}