{
  "FullStudy":{
    "Rank":217942,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514825",
          "OrgStudyIdInfo":{
            "OrgStudyId":"150-CL-026"
          },
          "Organization":{
            "OrgFullName":"Astellas Pharma Inc",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly Subjects",
          "OfficialTitle":"YM150 Clinical Pharmacology Study - Repeated Oral Administration to Elderly Subjects"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2006"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2007",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2007",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 23, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 24, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Astellas Pharma Inc",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to evaluate the safety and plasma concentration change of YM150 after repeated administration to healthy elderly male and female subjects."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy Elderly Subject",
              "Pharmacokinetic of YM150"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "YM150",
              "Plasma concentration",
              "darexaban",
              "Healthy elderly subject",
              "Pharmacokinetics of YM150"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"36",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"YM150 low dose group",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: YM150"
                  ]
                }
              },{
                "ArmGroupLabel":"YM150 middle dose group",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: YM150"
                  ]
                }
              },{
                "ArmGroupLabel":"YM150 high dose group",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: YM150"
                  ]
                }
              },{
                "ArmGroupLabel":"placebo group",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"YM150",
                "InterventionDescription":"oral",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "YM150 high dose group",
                    "YM150 low dose group",
                    "YM150 middle dose group"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "darexaban"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Placebo",
                "InterventionDescription":"oral",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "placebo group"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Cmax of YM150 assessed by its plasma concentration change",
                "PrimaryOutcomeTimeFrame":"for 7 days"
              },{
                "PrimaryOutcomeMeasure":"AUC of YM150 assessed by its plasma concentration change",
                "PrimaryOutcomeTimeFrame":"for 7 days"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa",
                "SecondaryOutcomeTimeFrame":"for 7 days"
              },{
                "SecondaryOutcomeMeasure":"Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests",
                "SecondaryOutcomeTimeFrame":"for 7 days"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy, as judged by the investigator or sub-investigator based on the results of physical examinations and all tests\nBody weight: male: ≥45.0 kg, <85.0 kg; female: ≥40.0 kg, <75.0 kg\nBMI (at screening): ≥17.6, <30.0\n\nExclusion Criteria:\n\nUse of any other investigational drug in another clinical study or a post-marketing clinical study within 120 days before the administration of the study drug\nDonated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment.\nAny surgical intervention (including tooth extraction) or trauma within 90 days before hospitalization until the administration, or plan of any surgical intervention within 10 week after the final administration\nA deviation from the normal reference range of blood pressure, pulse rate, body temperature, or 12-lead ECG\nPT or aPTT on blood coagulation tests outside the upper or lower reference limits (PT: 9.9 to 15.4 sec.; aPTT: 22.5 to 49.5 sec.)\nUpper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study\nConcurrent or previous hepatic disease (e.g. viral hepatitis, drug-induced liver injury)\nConcurrent or previous heart disease (e.g. congestive heart failure, angina pectoris, arrhythmia requiring treatment)\nConcurrent or previous respiratory disease (e.g. serious bronchial asthma, chronic bronchitis; except for a history of childhood asthma)\nConcurrent or previous renal disease (e.g. acute renal failure, glomerulonephritis, interstitial nephritis; except for a history of calculus)\nConcurrent or previous malignant tumor\nExcessive smoking or drinking habit [measure of \"excessive\": alcohol: average 45 g/day (a 633 mL bottle of beer contains 25 g of alcohol, and 180 mL of Japanese sake contains 22 g of alcohol), smoking: average 20 cigarettes/day]\nPrevious treatment with YM150",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"65 Years",
          "MaximumAge":"79 Years",
          "StdAgeList":{
            "StdAge":[
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Use Central Contact",
                "OverallOfficialAffiliation":"Astellas Pharma Inc",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationCity":"Kyushu",
                "LocationCountry":"Japan"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"C000569750",
                "InterventionMeshTerm":"Darexaban"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "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"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000000925",
                "InterventionAncestorTerm":"Anticoagulants"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M234983",
                "InterventionBrowseLeafName":"Darexaban",
                "InterventionBrowseLeafAsFound":"Darexaban",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "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":"M2825",
                "InterventionBrowseLeafName":"Anticoagulants",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"T18",
                "InterventionBrowseLeafName":"Serine",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"AnCoag",
                "InterventionBrowseBranchName":"Anticoagulants"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"AA",
                "InterventionBrowseBranchName":"Amino Acids"
              }
            ]
          }
        }
      }
    }
  }
}