[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538636":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":27,"centralContacts":31,"locations":36,"responsibleParty":52,"collaborators":24,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":24,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":24,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Korea University Anam Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","Ezetimibe\u002Ffenofibrate (Ezefeno) and moderate-intensity statin",[13],"Drug: Ezetimibe\u002Ffenofibrate (Ezefeno) and moderate-intensity statin",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Dose escalation of moderate-intensity statin",[19],"Drug: Dose escalation of moderate-intensity statin",[21,25],{"type":22,"name":11,"description":9,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":22,"name":17,"description":15,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"affiliation":5,"role":30},"SIN-GON KIM","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":24,"email":35},"CONTACT","8229205890","k50367@korea.ac.kr",[37],{"facility":5,"status":38,"city":39,"state":24,"zip":24,"country":40,"countryCode":24,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Seoul","South Korea",{"type":42,"coordinates":43},"Point",[44,45],126.9784,37.566,{"lat":45,"lon":44},[48,50],{"name":49,"role":33,"phone":24,"phoneExt":24,"email":24},"Sin Gon Kim, MD",{"name":51,"role":30,"phone":24,"phoneExt":24,"email":24},"Sin Gon Kim, MD, PHD",{"type":30,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Sin Gon Kim","professor","100538636","to-assess-with-ezefeno-tab-in-patients-with-dyslipidemia-and-t2dm-100538636",false,"NCT06293417","To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM","To Assess the Long-term Efficacy and Safety of Combined Therapy With Ezefeno Tab. in Patients With Dyslipidemia Who do Not Achieve Adequate Control of Non-HDL-C Levels Even With Moderate-intensity Monotherapy","ENSEMBLE","Inclusion Criteria:\n\n* Patients with type 2 diabetes diagnosed by American Diabetes Association criteria\n* Age ≥ 19 years\n* Non-HDL-C ≥100 mg\u002FdL, TG ≥200, \\\u003C500 mg\u002FdL on moderate-intensity statins\n* with cardiovascular risk factor\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.)\n* Patient with myopathy and rhabdomyolysis\n* AST\u002FALT more than 3 ULN\n* Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and\u002For glucose-galactose malabsorption","ALL","19 Years",{"count":66,"type":67},3958,"ESTIMATED","INTERVENTIONAL",[70],"NA","The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:\n\n* major adverse cardiovascular events within 48 months of the trial duration\n* microvascular events within 48 months of the trial duration",[73,74],"T2DM (Type 2 Diabetes Mellitus)","Dyslipidemias","2024-08-25",{"date":77,"type":78},"2024-08-27","ACTUAL",{"date":80,"type":78},"2024-03-01",{"date":82,"type":67},"2027-02-01",{"name":5,"class":6},1]