Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT01181167
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2010-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552171', 'term': 'edoxaban'}, {'id': 'C000711671', 'term': 'enoxaparin sodium'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fukuzawa.masayuki.gn@daiichisankyo.co.jp', 'phone': '81-90-5584-2197', 'title': 'Masayuki Fukuzawa, Associate Director', 'organization': 'Daiichi Sankyo Co., Ltd.'}, 'certainAgreement': {'otherDetails': 'PI shall not publish the results of the Study at any time without the prior written approval of Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'DU-176b', 'description': 'DU-176b oral tablets, 30 mg., taken once daily for 2 weeks\n\nedoxaban', 'otherNumAtRisk': 303, 'otherNumAffected': 197, 'seriousNumAtRisk': 303, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Enoxaparin Sodium', 'description': 'enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks\n\nenoxaparin sodium', 'otherNumAtRisk': 301, 'otherNumAffected': 232, 'seriousNumAtRisk': 301, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 98, 'numAffected': 97}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 45, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 81, 'numAffected': 79}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 37, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 128, 'numAffected': 126}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 39, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 37, 'numAffected': 34}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 41, 'numAffected': 40}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'Haemorrhage subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}], 'seriousEvents': [{'term': 'deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'otrhostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'Dislocation of joint prosthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'abcess jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}, {'term': 'gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/JV.12.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Subjects With Venous Thromboembolism Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b', 'description': 'DU-176b oral tablets, 30 mg., taken once daily for 2 weeks\n\nedoxaban'}, {'id': 'OG001', 'title': 'Enoxaparin Sodium', 'description': 'enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks\n\nenoxaparin sodium'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '5.0'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '10.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-4.5', 'pValueComment': 'Farrington Manning Method', 'groupDescription': 'Hypothesis testing of proportion of subjects who experienced at least one thromboembolic events, defined as primary endpoint, carried out using Farrington-Manning method. Null hypothesis H˅01: Incidence of thromboembolic events in DU-176b group (P˅DU) = Incidence of thromboembolic events in enoxaparin group (P˅E) + Δ (8%). Alternative hypothesis H˅11: P˅DU \\< P˅E + Δ (significance level: One-sided, 0.025)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Difference in incidence of thromboembolic events between DU-176b and enoxaparin groups and 95% confidence interval (CI) were calculated.\n\nIncidence of thromboembolic events and 95% CI also calculated by treatment group.\n\nOnly when null hypothesis H01 was rejected, upper limit of 95% CI for difference between DU-176b and enoxaparin groups was confirmed. When upper limit of 95% CI was below 0%, DU-176b was considered to be superior to enoxaparin in terms of the prevention of VTE.'}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.\n\n* Lower extremity DVT confirmed by bilateral venography at the end of study treatment\n* Definite diagnosis of symptomatic PE\n* Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE', 'unitOfMeasure': 'percentage of subjects with vte events', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.'}, {'type': 'SECONDARY', 'title': 'Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b', 'description': 'DU-176b oral tablets, 30 mg., taken once daily for 2 weeks\n\nedoxaban'}, {'id': 'OG001', 'title': 'Enoxaparin Sodium', 'description': 'enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks\n\nenoxaparin sodium'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '5.1'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '6.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'unitOfMeasure': 'percentage of subjects with bleeds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analyses were performed for the Safety Analysis Set, which was defined as all subjects who were secondarily enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or who had no safety data after the start of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DU-176b', 'description': 'DU-176b oral tablets, 30 mg., taken once daily for 2 weeks\n\nedoxaban'}, {'id': 'FG001', 'title': 'Enoxaparin Sodium', 'description': 'enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks\n\nenoxaparin sodium'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '303'}]}, {'type': 'Efficacy Analysis Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '255'}, {'groupId': 'FG001', 'numSubjects': '248'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '271'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '503', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DU-176b', 'description': 'DU-176b oral tablets, 30 mg., taken once daily for 2 weeks\n\nedoxaban'}, {'id': 'BG001', 'title': 'Enoxaparin Sodium', 'description': 'enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks\n\nenoxaparin sodium'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '9.61', 'groupId': 'BG000'}, {'value': '62.8', 'spread': '9.72', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '9.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '255', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '503', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '255', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '503', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Number of baseline participants reflects the efficacy analysis population.'}}, 'protocolSection': {'designModule': {'phases': ['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': '2015-02', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2010-08-12', 'resultsFirstSubmitDate': '2015-01-15', 'studyFirstSubmitQcDate': '2010-08-12', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-01-15', 'studyFirstPostDateStruct': {'date': '2010-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Subjects With Venous Thromboembolism Events', 'timeFrame': '2 weeks', 'description': 'The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.\n\n* Lower extremity DVT confirmed by bilateral venography at the end of study treatment\n* Definite diagnosis of symptomatic PE\n* Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE'}], 'secondaryOutcomes': [{'measure': 'Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding', 'timeFrame': '2 weeks'}]}, 'conditionsModule': {'keywords': ['Anticoagulants', 'Venous thromboembolism', 'Thromboembolism', 'Thrombosis', 'enoxaparin sodium', 'Embolism', 'Deep vein thrombosis', 'DU-176b', 'edoxaban', 'factor Xa', 'total hip arthroplasty'], 'conditions': ['Prevention', 'Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '27980462', 'type': 'DERIVED', 'citation': 'Kawai Y, Fuji T, Fujita S, Kimura T, Ibusuki K, Abe K, Tachibana S. Edoxaban versus enoxaparin for the prevention of venous thromboembolism after total knee or hip arthroplasty: pooled analysis of coagulation biomarkers and primary efficacy and safety endpoints from two phase 3 trials. Thromb J. 2016 Dec 1;14:48. doi: 10.1186/s12959-016-0121-1. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing unilateral total hip arthroplasty\n\nExclusion Criteria:\n\n* Subjects with risks of hemorrhage\n* Subjects with thromboembolic risks\n* Subjects who weigh less than 40 kg\n* Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant'}, 'identificationModule': {'nctId': 'NCT01181167', 'briefTitle': 'A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Double-Dummy Efficacy and Safety Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-5 Trial)', 'orgStudyIdInfo': {'id': 'DU176b-B-J304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DU-176b', 'description': 'DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery.', 'interventionNames': ['Drug: edoxaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'enoxaparin sodium', 'description': 'enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery.', 'interventionNames': ['Drug: enoxaparin sodium']}], 'interventions': [{'name': 'edoxaban', 'type': 'DRUG', 'armGroupLabels': ['DU-176b']}, {'name': 'enoxaparin sodium', 'type': 'DRUG', 'armGroupLabels': ['enoxaparin sodium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Takeshi Fuji', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osaka Koseinenkin Hospital'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}