Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT00937820
Status:
COMPLETED
Last Update Posted:
2011-01-06
First Post:
2009-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Recurrence of Venous Thromboembolism in Patients With a History of Venous Thromboembolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-05', 'studyFirstSubmitDate': '2009-07-09', 'studyFirstSubmitQcDate': '2009-07-10', 'lastUpdatePostDateStruct': {'date': '2011-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint incidence of deep vein thromboembolism or pulmonary thromboembolism', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Incidence of each thromboembolism', 'timeFrame': '52 weeks'}, {'measure': 'All cause mortality', 'timeFrame': '52 weeks'}, {'measure': 'Incidence of bleeding event', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['YM150', 'Bleeding', 'VTE', 'FXa inhibitor', 'Venous thromboembolism'], 'conditions': ['Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'The study objective is to evaluate the efficacy and safety of oral YM150 for 52 weeks in patients with a history of venous thromboembolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has symptomatic VTE and/or asymptomatic deep vein thrombosis\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\n* Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke\n* Subject is receiving anticoagulants/antiplatelet agents\n* Subject has a body weight less than 40 kg'}, 'identificationModule': {'nctId': 'NCT00937820', 'briefTitle': 'Prevention of Recurrence of Venous Thromboembolism in Patients With a History of Venous Thromboembolism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'YM150 Long Term Study - Long-term Study in Patients With a History of Venous Thromboembolism', 'orgStudyIdInfo': {'id': '150-CL-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YM150 group', 'interventionNames': ['Drug: YM150']}], 'interventions': [{'name': 'YM150', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['YM150 group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan'}, {'city': 'Chūbu', 'country': 'Japan', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Kansai', 'country': 'Japan'}, {'city': 'Kantou', 'country': 'Japan'}, {'city': 'Tōhoku', 'country': 'Japan', 'geoPoint': {'lat': 44.62026, 'lon': 142.29986}}], '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'}}}}