[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576756":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":53,"collaborators":11,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":11,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Beximco Pharmaceuticals Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL",null,[13],"Drug: Atorvastatin 10 mg and ezetimibe 10 mg",{"label":15,"type":10,"description":11,"interventionNames":16},"Arm 2",[17],"Drug: Atorvastatin 20 mg",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Atorvastatin 10 mg and ezetimibe 10 mg","Atorvastatin\u002FEzetimibe 10\u002F10mg once daily",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Atorvastatin 20 mg","Atorvastatin (20 mg) Monotherapy once daily",[15],[29],{"name":30,"affiliation":31,"role":32},"Prof. Abdullah Al Shafi Majumder, MD, FACC, FRCP (E), FRCP (G)","Professor, Dept. of Cardiology, Popular Medical College, Dhaka.","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Dr. Md. Alimur Reza, MBBS, MPH","CONTACT","+8801711438139","rea@bpl.net",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":11},"Popular Medical College & Hospital","RECRUITING","Dhaka","Dhaka Division","Bangladesh","BD",{"type":48,"coordinates":49},"Point",[50,51],90.40744,23.7104,{"lat":51,"lon":50},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Dr. Md. Alimur Reza","Epidemiologist","100576756","phase-4-efficacy-and-safety-of-atorvastatin-and-ezetimibe-1010mg-fixed-dose-combination-versus-atorvastatin-20mg-monotherapy-in-bangladeshi-population-100576756",false,"NCT06789432","Efficacy and Safety of Atorvastatin and Ezetimibe (10\u002F10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population","Inclusion Criteria:\n\n* Men and women aged \\>18 years.\n* Patients with a confirmed diagnosis of elevated LDL-C levels necessitating medical management.\n* Patients in the low to moderate cardiovascular disease (CVD) risk category according to ESC guidelines (2019)\n\n  * Low-risk: Increased LDL-C level without any co-morbidities\n  * Moderate-risk: Young patients (T1DM \\\u003C35 years; T2DM \\\u003C50 years) with DM duration \\\u003C10 years, without other risk factors.\n\nExclusion Criteria:\n\n* History of hypersensitivity to any study drugs.\n* Clinically significant hepatic impairment (ALT, AST level \\> 2xULN) and\u002For renal impairment (Serum creatinine level ≥2xULN).\n* Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, cancer, psychiatric instability, HIV + status, intestinal malabsorption.\n* Pregnant or lactating females.\n* The presence of a condition that, in the opinion of the investigator, would place the subject at increased risk from study participation.","ALL","18 Years",{"count":66,"type":67},500,"ESTIMATED","INTERVENTIONAL",[70],"PHASE4","The goal of this clinical trial is to evaluate the efficacy and safety of a fixed-dose combination of atorvastatin (10 mg) and ezetimibe (10 mg) compared to atorvastatin (20 mg) monotherapy in the Bangladeshi population.\n\nResearchers will compare atorvastatin (10 mg) and ezetimibe (10 mg) to atorvastatin (20 mg) monotherapy to see if atorvastatin (10 mg) and ezetimibe (10 mg) FDC works to treat dyslipidemia.\n\nParticipants will:\n\n* Take a fixed-dose combination of atorvastatin (10 mg) and ezetimibe (10 mg) compared to atorvastatin (20 mg) monotherapy for 3 months\n* Follow-up visits at 6 weeks and 12 weeks for checkups and tests",[73],"Hyperlipidemia (E.G., Hypercholesterolemia)",[75,76,77],"increased LDL-C level","Hyperlipidemia","Atorvastatin (10 mg) and Ezetimibe (10 mg)","2025-07-25",{"date":80,"type":81},"2025-07-29","ACTUAL",{"date":83,"type":81},"2025-02-01",{"date":85,"type":67},"2025-12",{"name":55,"class":6},1]