Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-27 @ 1:29 AM
Study NCT ID:
NCT01028950
Status:
COMPLETED
Last Update Posted:
2010-06-16
First Post:
2009-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], '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'}, {'id': 'D013927', 'term': 'Thrombosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-14', 'studyFirstSubmitDate': '2009-12-07', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite assessment of VTE events and all cause death', 'timeFrame': 'Until day 28'}], 'secondaryOutcomes': [{'measure': 'Incidence of bleeding events', 'timeFrame': 'Until day 28'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['YM150', 'Bleeding', 'VTE', 'FXa inhibitor', 'Deep Vein Thrombosis', 'Venous thromboembolism'], 'conditions': ['Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is hospitalized within 2 days before the study and has more than 1 basic VTE risks\n* Complete bed rest is required in the fist day of hospitalization and at least 4 days hospitalization\n* Written informed consent obtained\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 obtaining informed consent\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\n* Major trauma, major surgery, eye, spinal cord and/or brain surgery within 90 days prior to obtaining informed consent, or the subject scheduled for these surgeries during the study periods'}, 'identificationModule': {'nctId': 'NCT01028950', 'briefTitle': 'YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Multi-center, Open Label Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness', 'orgStudyIdInfo': {'id': '150-CL-044'}}, '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'}}}}