[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100144104":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":25,"locations":33,"responsibleParty":44,"collaborators":46,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":25,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":25,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":73,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Boryung Pharmaceutical Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"hepatic impairment patients","EXPERIMENTAL","Hepatic impairment patients group Child-Pugh score A or Child-Pugh score B (not Child-Pugh score C)",[13],"Drug: fimasartan",{"label":15,"type":16,"description":17,"interventionNames":18},"Healthy volunteers","ACTIVE_COMPARATOR","healthy volunteers group",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","fimasartan","single administration of fimasartan 120mg",[9],null,{"type":21,"name":22,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":31,"role":32},"Minsoo Park, PhD","Yonsei University","PRINCIPAL_INVESTIGATOR",[34],{"facility":35,"status":25,"city":36,"state":25,"zip":25,"country":37,"countryCode":25,"cosmosGeoPoint":38,"geoPoint":43,"contacts":25},"Severance Hospital","Seoul","South Korea",{"type":39,"coordinates":40},"Point",[41,42],126.9784,37.566,{"lat":42,"lon":41},{"type":45,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[47,50],{"name":48,"class":49},"Kyungpook National University Hospital","OTHER",{"name":31,"class":49},"100144104","phase-1-a-clinical-trial-to-compare-and-evaluate-the-pharmacokinetic-characteristics-and-the-safety-of-fimasartan-in-hepatic-impairment-patients-and-healthy-volunteers-100144104",false,"NCT01146938","A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers","Inclusion Criteria:\n\n\\\u003CHepatic impairment patient\\>\n\n* age: 20 - 64 years\n* sex: male\n* Child-Pugh score A or Child-Pugh score B\n* body weight: greater than 55 kg\n* written informed consent\n\n\\\u003CHealthy volunteer\\>\n\n* age: 20 - 64 years\n* sex: male\n* body weight: greater than 55 kg\n* written informed consent\n\nExclusion Criteria:\n\n\\\u003CHepatic impairment patient\\>\n\n* portosystemic shunt surgery\n* Child-Pugh score C\n* creatinine clearance \\\u003C 80mL\u002Fmin\n* ascites\n\n\\\u003CHealthy volunteer\\>\n\n* AST(SGOT), ALT(SGPT) \\> 1.5 times of Upper Normal Range\n* Total bilirubin \\> 1.5 times of Upper Normal Range\n* positive drug or alcohol screening",true,"MALE","20 Years","64 Years",{"count":62,"type":63},18,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers",[69,70],"Essential Hypertension","Hepatic Impairment",[22,72],"hepatic impairment","COMPLETED","2012-01-02",{"date":76,"type":63},"2012-01-05",{"date":78,"type":25},"2010-05",{"date":80,"type":81},"2011-02","ACTUAL",{"name":5,"class":6},1]