[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612610":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":41,"locations":50,"responsibleParty":73,"collaborators":29,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":29,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":29,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":53,"whyStopped":29,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Bahria University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Rosuvastatin + Ezetimibe","ACTIVE_COMPARATOR","Rosuvastatin is a statin that lowers LDL cholesterol by inhibiting HMG-CoA reductase. Ezetimibe inhibits cholesterol absorption in the intestine.",[13],"Drug: Rosuvastatin + Ezetimibe",{"label":15,"type":10,"description":16,"interventionNames":17},"Bempedoic Acid + Ezetimibe","Bempedoic acid is an ATP citrate lyase inhibitor that reduces LDL cholesterol. Ezetimibe inhibits diatery cholesterol absorption in the intestine",[18],"Drug: Bempedoic Acid + Ezetimibe",{"label":20,"type":10,"description":21,"interventionNames":22},"Rosuvastatin + Ezetimibe + Bempedoic Acid","This triple therapy combines statin therapy with cholesterol absorption inhibition and ATP citrate lyase inhibition to optimize LDL reduction.",[23],"Drug: Rosuvastatin + Ezetimibe + Bempedoic Acid",[25,30,33],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Group A (Dual therapy 1): Tab Rosuvastatin 20 mg + Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days",[9],null,{"type":26,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"Group B (Dual therapy 2): Tab Bempedoic Acid 180mg+ Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days",[15],{"type":26,"name":20,"description":34,"armGroupLabels":35,"otherNames":29},"Group C (Triple therapy): Tab Rosuvastatin 20 mg+ Tab Ezetimibe 10mg+ Tab Bempedoic Acid 180mg orally, once daily for 90 days",[20],[37],{"name":38,"affiliation":39,"role":40},"Fatima Khatoon, MBBS","Bahria University, Islamabad","PRINCIPAL_INVESTIGATOR",[42,46],{"name":38,"role":43,"phone":44,"phoneExt":29,"email":45},"CONTACT","+923213334507","fatima.omair@gmail.com",{"name":47,"role":43,"phone":48,"phoneExt":29,"email":49},"Ijaz Hussain Zaidi, MBBS, MPHIL, PHD","+923212794282","syedijaz.bumdc@bahria.edu.pk",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"National Medical Center","RECRUITING","Karachi","Sindh","75500","Pakistan","PK",{"type":60,"coordinates":61},"Point",[62,63],67.0104,24.8608,{"lat":63,"lon":62},[66,70,71],{"name":67,"role":43,"phone":68,"phoneExt":29,"email":69},"Dr. Muhammad Sajid Abbas Jaffri, MBBS, MCPS, FCPS,","+923002139364","muhammadsajidjaffri@gmail.com",{"name":38,"role":43,"phone":44,"phoneExt":29,"email":45},{"name":38,"role":72,"phone":29,"phoneExt":29,"email":29},"SUB_INVESTIGATOR",{"type":40,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Dr.Fatima khatoon","MPhil Candidate","100612610","phase-4-dual-vs-triple-lipid-lowering-therapy-in-type-2-diabetes-mellitus-patients-with-elevated-ldl-cholesterol-100612610",false,"NCT07255820","Dual vs Triple Lipid-Lowering Therapy in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol","Comparative Efficacy and Safety of Dual Versus Triple Lipid-Lowering Therapies (Rosuvastatin\u002FEzetimibe, Bempedoic Acid\u002FEzetimibe, and Rosuvastatin\u002FEzetimibe\u002FBempedoic Acid ) in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol","Inclusion Criteria:\n\n* Males and females\n* Age 35-60 years\n* HbA1c ≥ 7.0 (≥ 48 mmol\u002Fmol)\n* On stable anti-diabetic therapy for at least 3 months\n* LDL-C \\> 100 mg\u002FdL on at least two occasions\n* Diagnosed with hypercholesterolemia\n* Establish high cardiovascular risk (e.g, previous MI, stroke or atherosclerosis) or\n* ≥2 cardiovascular risk factors (hypertension, smoking, obesity, family history)\n* BMI \\>23 - \\\u003C32(WHO Asian Criteria)\n* No prior statin side effects\n\nExclusion Criteria:\n\n* HbA1c \\>10 % (86 mmol\u002Fmol)\n* BMI \\> 32\n* Type 1 Diabetes, gestational diabetes\n* Pregnancy or lactation\n* Acute liver disease or ALT\u002FAST levels \\> 3× the upper limit of normal\n* Renal failure (GFR \\\u003C 30 mL\u002Fmin)\n* Uncontrolled hypothyroidism or nephrotic syndrome\n* Recent cancer diagnosis (last 6 months)\n* Current use of other lipid-lowering agents (e.g., fibrates or PCSK9 inhibitors)\n* Known allergy to any component\n* Statin intolerance with severe adverse effects (e.g., rhabdomyolysis)","ALL","35 Years","60 Years",{"count":87,"type":88},126,"ESTIMATED","INTERVENTIONAL",[91],"PHASE4","This Open-label, randomized clinical trial evaluates the comparative efficacy and safety of dual versus triple lipid-lowering therapy using rosuvastatin, ezetimibe, and bempedoic acid in patients with type 2 diabetes mellitus and elevated LDL cholesterol. The study aims to determine whether adding bempedoic acid to standard dual therapy provides superior lipid control without compromising safety. The 126 participants, aged 35 - 60 years will be randomly assigned to one of three treatment groups for 12 weeks, and their lipid profiles, glycemic control, and adverse effects will be monitored.The total duration of study will be 6 months, with a 3 months individual treatment period.",[94,95],"Type 2 Diabetes Mellitus","Hypercholesterolemia \u002F Elevated LDL Cholesterol",[97,98,99,100,101,102],"Lipid-lowering therapy,","Rosuvastatin, Ezetimibe, Bempedoic Acid","Dual therapy vs Triple therapy","LDL-C","Dyslipidemia","Type 2 Diabetes","2026-06-23",{"date":105,"type":106},"2026-06-26","ACTUAL",{"date":108,"type":106},"2026-01-01",{"date":110,"type":88},"2026-06-30",{"name":5,"class":6},1]