{ "FullStudy":{ "Rank":217787, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516840", "OrgStudyIdInfo":{ "OrgStudyId":"14568" }, "Organization":{ "OrgFullName":"Bayer", "OrgClass":"INDUSTRY" }, "BriefTitle":"Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients", "OfficialTitle":"Randomized, Open-label (Double Blind Among Rivaroxaban Groups in the Initial 3 Weeks), Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis Without Symptomatic Pulmonary Embolism" }, "StatusModule":{ "StatusVerifiedDate":"January 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 20, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 17, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 18, 2017", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Bayer", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Janssen Scientific Affairs, LLC", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.", "DetailedDescription":"The general design of the trial is open label between the Rivaroxaban and the reference arm. However, there are two groups in the Rivaroxaban arm only for the initial 3 weeks. Between these two groups and in this initial period, the study is blinded." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Deep Vein Thrombosis" ] }, "KeywordList":{ "Keyword":[ "acute symptomatic deep vein thrombosis" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"60", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Arm 1", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Rivaroxaban (Xarelto, BAY59-7939)" ] } },{ "ArmGroupLabel":"Arm 2", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Rivaroxaban (Xarelto, BAY59-7939)" ] } },{ "ArmGroupLabel":"Arm 3", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Unfractionated heparin" ] } },{ "ArmGroupLabel":"Arm 4", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Warfarin" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Rivaroxaban (Xarelto, BAY59-7939)", "InterventionDescription":"10 mg twice daily for 21 days, followed by 15 mg once daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 1" ] } },{ "InterventionType":"Drug", "InterventionName":"Rivaroxaban (Xarelto, BAY59-7939)", "InterventionDescription":"15 mg twice daily for 21 days, followed by 15 mg once daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 2" ] } },{ "InterventionType":"Drug", "InterventionName":"Unfractionated heparin", "InterventionDescription":"To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 3" ] } },{ "InterventionType":"Drug", "InterventionName":"Warfarin", "InterventionDescription":"To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 4" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of participants with newly onset of symptomatic venous thromboembolism (VTE)", "PrimaryOutcomeTimeFrame":"Up to 12 months" },{ "PrimaryOutcomeMeasure":"Number of clinically relevant bleedings", "PrimaryOutcomeTimeFrame":"Up to 2 days after last dose" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Number of participants with improvement in thrombotic burden", "SecondaryOutcomeTimeFrame":"At week 3" },{ "SecondaryOutcomeMeasure":"Number of participants with deterioration in thrombotic burden", "SecondaryOutcomeTimeFrame":"Up to 12 months" },{ "SecondaryOutcomeMeasure":"Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus", "SecondaryOutcomeTimeFrame":"Up to 12 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMen and women >/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE)\n\nExclusion Criteria:\n\nThrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT\nMore than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of DVT to randomization\nCalculated creatinine clearance (CLCR) < 30 mL/min\nSubjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk\nActive bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin\nSystolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"20 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Bayer Study Director", "OverallOfficialAffiliation":"Bayer", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Toyoake", "LocationState":"Aichi", "LocationZip":"470-1192", "LocationCountry":"Japan" },{ "LocationCity":"Sakura", "LocationState":"Chiba", "LocationZip":"285-8741", "LocationCountry":"Japan" },{ "LocationCity":"Maebashi", "LocationState":"Gunma", "LocationZip":"371-8511", "LocationCountry":"Japan" },{ "LocationCity":"Otake", "LocationState":"Hiroshima", "LocationZip":"739-0696", "LocationCountry":"Japan" },{ "LocationCity":"Sapporo", "LocationState":"Hokkaido", "LocationZip":"006-8555", "LocationCountry":"Japan" },{ "LocationCity":"Takarazuka", "LocationState":"Hyogo", "LocationZip":"665-0827", "LocationCountry":"Japan" },{ "LocationCity":"Kahoku-gun", "LocationState":"Ishikawa", "LocationZip":"920-0293", "LocationCountry":"Japan" },{ "LocationCity":"Kanazawa", "LocationState":"Ishikawa", "LocationZip":"920-8650", "LocationCountry":"Japan" },{ "LocationCity":"Yokohama", "LocationState":"Kanagawa", "LocationZip":"245-8575", "LocationCountry":"Japan" },{ "LocationCity":"Tsu", "LocationState":"Mie", "LocationZip":"514-8507", "LocationCountry":"Japan" },{ "LocationCity":"Sasebo", "LocationState":"Nagasaki", "LocationZip":"857-8511", "LocationCountry":"Japan" },{ "LocationCity":"Osakasayama", "LocationState":"Osaka", "LocationZip":"589-8511", "LocationCountry":"Japan" },{ "LocationCity":"Suita", "LocationState":"Osaka", "LocationZip":"565-8565", "LocationCountry":"Japan" },{ "LocationCity":"Bunkyo-ku", "LocationState":"Tokyo", "LocationZip":"113-8655", "LocationCountry":"Japan" },{ "LocationCity":"Chuoku", "LocationState":"Tokyo", "LocationZip":"104-8560", "LocationCountry":"Japan" },{ "LocationCity":"Itabashi-ku", "LocationState":"Tokyo", "LocationZip":"173-8610", "LocationCountry":"Japan" },{ "LocationCity":"Meguro-ku", "LocationState":"Tokyo", "LocationZip":"152-8902", "LocationCountry":"Japan" },{ "LocationCity":"Shinagawa", "LocationState":"Tokyo", "LocationZip":"141-8625", "LocationCountry":"Japan" },{ "LocationCity":"Shinjuku-ku", "LocationState":"Tokyo", "LocationZip":"162-8655", "LocationCountry":"Japan" },{ "LocationCity":"Aomori", "LocationZip":"030-8553", "LocationCountry":"Japan" },{ "LocationCity":"Fukuoka", "LocationZip":"810-0001", "LocationCountry":"Japan" },{ "LocationCity":"Kumamoto", "LocationZip":"862-8505", "LocationCountry":"Japan" },{ "LocationCity":"Niigata", "LocationZip":"951-8520", "LocationCountry":"Japan" },{ "LocationCity":"Okayama", "LocationZip":"701-1192", "LocationCountry":"Japan" },{ "LocationCity":"Osaka", "LocationZip":"530-8480", "LocationCountry":"Japan" },{ "LocationCity":"Osaka", "LocationZip":"537-8511", "LocationCountry":"Japan" },{ "LocationCity":"Shizuoka", "LocationZip":"424-8636", "LocationCountry":"Japan" },{ "LocationCity":"Tokushima", "LocationZip":"770-8503", "LocationCountry":"Japan" },{ "LocationCity":"Wakayama", "LocationZip":"640-8158", "LocationCountry":"Japan" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25851062", "ReferenceType":"derived", "ReferenceCitation":"Matsuo H, Prins M, Lensing AW, Fujinuma EW, Miyamoto Y, Kajikawa M. Shortened length of hospital stay with rivaroxaban in patients with symptomatic venous thromboembolism in Japan: the J-EINSTEIN pulmonary embolism and deep vein thrombosis program. Curr Med Res Opin. 2015 Jun;31(6):1057-61. doi: 10.1185/03007995.2015.1037728. Epub 2015 May 11." },{ "ReferencePMID":"25717286", "ReferenceType":"derived", "ReferenceCitation":"Yamada N, Hirayama A, Maeda H, Sakagami S, Shikata H, Prins MH, Lensing AW, Kato M, Onuma J, Miyamoto Y, Iekushi K, Kajikawa M. Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism - the J-EINSTEIN DVT and PE program. Thromb J. 2015 Jan 17;13:2. doi: 10.1186/s12959-015-0035-3. eCollection 2015. Erratum in: Thromb J. 2016;14:11." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000006493", "InterventionMeshTerm":"Heparin" },{ "InterventionMeshId":"C000006871", "InterventionMeshTerm":"Calcium heparin" },{ "InterventionMeshId":"D000014859", "InterventionMeshTerm":"Warfarin" },{ "InterventionMeshId":"D000069552", "InterventionMeshTerm":"Rivaroxaban" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000925", "InterventionAncestorTerm":"Anticoagulants" },{ "InterventionAncestorId":"D000005343", "InterventionAncestorTerm":"Fibrinolytic Agents" },{ "InterventionAncestorId":"D000050299", "InterventionAncestorTerm":"Fibrin Modulating Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000065427", "InterventionAncestorTerm":"Factor Xa Inhibitors" },{ "InterventionAncestorId":"D000000991", "InterventionAncestorTerm":"Antithrombins" },{ "InterventionAncestorId":"D000015842", "InterventionAncestorTerm":"Serine Proteinase Inhibitors" },{ "InterventionAncestorId":"D000011480", "InterventionAncestorTerm":"Protease Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M463", "InterventionBrowseLeafName":"Rivaroxaban", "InterventionBrowseLeafAsFound":"Rivaroxaban", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8162", "InterventionBrowseLeafName":"Heparin", "InterventionBrowseLeafAsFound":"Unfractionated heparin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M45199", "InterventionBrowseLeafName":"Calcium heparin", "InterventionBrowseLeafAsFound":"Unfractionated heparin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M16185", "InterventionBrowseLeafName":"Warfarin", "InterventionBrowseLeafAsFound":"Warfarin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M3963", "InterventionBrowseLeafName":"Calcium", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3980", "InterventionBrowseLeafName":"Calcium, Dietary", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2825", "InterventionBrowseLeafName":"Anticoagulants", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7056", "InterventionBrowseLeafName":"Fibrinolytic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M29100", "InterventionBrowseLeafName":"Factor Xa Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2888", "InterventionBrowseLeafName":"Antithrombins", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2887", "InterventionBrowseLeafName":"Antithrombin III", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M12926", "InterventionBrowseLeafName":"Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M16974", "InterventionBrowseLeafName":"Serine Proteinase Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M18192", "InterventionBrowseLeafName":"HIV Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T18", "InterventionBrowseLeafName":"Serine", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"AnCoag", "InterventionBrowseBranchName":"Anticoagulants" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"FiAg", "InterventionBrowseBranchName":"Fibrinolytic Agents" },{ "InterventionBrowseBranchAbbrev":"BDCA", "InterventionBrowseBranchName":"Bone Density Conservation Agents" },{ "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"AA", "InterventionBrowseBranchName":"Amino Acids" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000013927", "ConditionMeshTerm":"Thrombosis" },{ "ConditionMeshId":"D000020246", "ConditionMeshTerm":"Venous Thrombosis" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000016769", "ConditionAncestorTerm":"Embolism and Thrombosis" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M15269", "ConditionBrowseLeafName":"Thrombosis", "ConditionBrowseLeafAsFound":"Thrombosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13092", "ConditionBrowseLeafName":"Pulmonary Embolism", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6367", "ConditionBrowseLeafName":"Embolism", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M20655", "ConditionBrowseLeafName":"Venous Thrombosis", "ConditionBrowseLeafAsFound":"Deep Vein Thrombosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M15265", "ConditionBrowseLeafName":"Thromboembolism", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M26367", "ConditionBrowseLeafName":"Venous Thromboembolism", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M17711", "ConditionBrowseLeafName":"Embolism and Thrombosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" } ] } } } } } }