{"id":"ezetimibe-10-simvastatin-20","safety":{"commonSideEffects":[{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Elevated liver enzymes"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Rhabdomyolysis (rare)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ezetimibe selectively inhibits Niemann-Pick C1-like 1 (NPC1L1) protein in the intestinal brush border, reducing dietary and biliary cholesterol absorption. Simvastatin is an HMG-CoA reductase inhibitor that decreases hepatic cholesterol synthesis. Together, they provide complementary mechanisms to lower LDL cholesterol and reduce cardiovascular risk.","oneSentence":"This combination reduces cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting hepatic cholesterol synthesis (simvastatin).","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:46:08.096Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypercholesterolemia and mixed dyslipidemia"}]},"trialDetails":[{"nctId":"NCT07307989","phase":"PHASE2","title":"Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With Atherosclerosis","status":"RECRUITING","sponsor":"Chang Gung Memorial Hospital","startDate":"2025-08-01","conditions":"Ischemic Stroke, Hypercholesteremia","enrollment":300},{"nctId":"NCT00650819","phase":"PHASE3","title":"Comparison of Ezetimibe Plus Simvastatin Versus Ezetimibe or Simvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03757)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2004-06-01","conditions":"Hypercholesterolemia","enrollment":240},{"nctId":"NCT00650663","phase":"PHASE4","title":"Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2003-10-01","conditions":"Hypercholesterolemia, Atherosclerosis","enrollment":247},{"nctId":"NCT00653835","phase":"PHASE4","title":"Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2003-09-01","conditions":"Hypercholesterolaemia, Atherosclerosis","enrollment":153},{"nctId":"NCT00652301","phase":"PHASE3","title":"A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2003-07","conditions":"Cholesterol","enrollment":40},{"nctId":"NCT00651274","phase":"PHASE4","title":"Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2003-04-01","conditions":"Atherosclerosis, Hypercholesterolemia, Coronary Heart Disease","enrollment":144},{"nctId":"NCT00092612","phase":"PHASE3","title":"Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2003-05","conditions":"Hypercholesterolemia, Coronary Disease","enrollment":372},{"nctId":"NCT00092599","phase":"PHASE3","title":"Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2003-02","conditions":"Hypercholesterolemia, Coronary Disease","enrollment":410},{"nctId":"NCT00166530","phase":"PHASE4","title":"EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)(0653A-089)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-11","conditions":"Atherosclerosis","enrollment":367},{"nctId":"NCT00651391","phase":"PHASE3","title":"Effect of Ezetimibe Plus Simvastatin on Flow-Mediated Brachial Artery Vasoactivity in Subjects With Primary Hypercholesterolemia (Study P03336)","status":"TERMINATED","sponsor":"Organon and Co","startDate":"2003-10-01","conditions":"Hypercholesterolemia, Atherosclerosis","enrollment":28},{"nctId":"NCT00442897","phase":"PHASE4","title":"Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-09","conditions":"Hypercholesterolemia","enrollment":229},{"nctId":"NCT00654628","phase":"PHASE4","title":"Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients (0653A-172)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2007-08-01","conditions":"Hypercholesterolemia","enrollment":173},{"nctId":"NCT00166504","phase":"PHASE4","title":"Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-10","conditions":"Hypercholesterolemia","enrollment":203},{"nctId":"NCT00423579","phase":"PHASE4","title":"The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-07-01","conditions":"Hypercholesterolemia, Coronary Disease","enrollment":120},{"nctId":"NCT00653523","phase":"PHASE3","title":"Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2007-12-01","conditions":"Hypercholesterolemia","enrollment":151},{"nctId":"NCT00496730","phase":"PHASE3","title":"A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2007-07","conditions":"Hypercholesterolemia","enrollment":256},{"nctId":"NCT00535405","phase":"PHASE3","title":"A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2007-11","conditions":"Hypercholesterolemia","enrollment":1289},{"nctId":"NCT00409773","phase":"PHASE3","title":"Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2007-01","conditions":"Hypercholesterolemia, Metabolic Syndrome","enrollment":1143},{"nctId":"NCT00782184","phase":"PHASE3","title":"Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2008-11","conditions":"Hypercholesterolemia","enrollment":250},{"nctId":"NCT00479713","phase":"PHASE3","title":"A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2007-02-01","conditions":"Hypercholesterolemia","enrollment":618},{"nctId":"NCT00862251","phase":"PHASE3","title":"Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2009-04","conditions":"Cardiovascular Disorder, Diabetes Mellitus","enrollment":808},{"nctId":"NCT00651014","phase":"PHASE4","title":"Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)","status":"TERMINATED","sponsor":"Organon and Co","startDate":"2004-01","conditions":"Hypercholesterolemia, Atherosclerosis","enrollment":82},{"nctId":"NCT00652431","phase":"PHASE1","title":"Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2007-05","conditions":"Hypercholesterolemia, Hyperlipidemia","enrollment":18},{"nctId":"NCT00413972","phase":"PHASE3","title":"Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-04","conditions":"Hypercholesterolemia","enrollment":392},{"nctId":"NCT01070966","phase":"","title":"Vytorin Reexamination Study (0653A-174)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-07","conditions":"Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)","enrollment":2089},{"nctId":"NCT00423488","phase":"PHASE3","title":"Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-07-12","conditions":"Hypercholesterolemia, Diabetes Mellitus, Type 2, Coronary Disease","enrollment":93},{"nctId":"NCT00652327","phase":"PHASE4","title":"Comparison of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Statin in the Treatment of Hypercholesterolemia (P04355)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-12","conditions":"Hypercholesterolemia","enrollment":83},{"nctId":"NCT00129402","phase":"PHASE3","title":"Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-08","conditions":"Hypercholesterolemia","enrollment":248},{"nctId":"NCT01420549","phase":"PHASE3","title":"Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia/Mixed Dyslipidemia","status":"COMPLETED","sponsor":"Ache Laboratorios Farmaceuticos S.A.","startDate":"2013-03","conditions":"Hypercholesterolemia, Dyslipidemia","enrollment":129},{"nctId":"NCT03543774","phase":"PHASE4","title":"Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population","status":"UNKNOWN","sponsor":"Hue University of Medicine and Pharmacy","startDate":"2018-06-15","conditions":"Hypercholesterolemia, Chronic Kidney Diseases","enrollment":30},{"nctId":"NCT00359281","phase":"PHASE2","title":"Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents","status":"COMPLETED","sponsor":"Aegerion Pharmaceuticals, Inc.","startDate":"2006-03","conditions":"Healthy","enrollment":125},{"nctId":"NCT00738296","phase":"PHASE4","title":"Vytorin on Carotid Intima-media Thickness and Overall Rigidity","status":"COMPLETED","sponsor":"Hospital Universitario 12 de Octubre","startDate":"2005-04","conditions":"Cardiovascular Diseases","enrollment":90},{"nctId":"NCT00738985","phase":"PHASE4","title":"Efficacy of Ezetimibe/Simvastatin 10/20 mg and MK0524A (1-2 g/Day) in Mixed Hyperlipidemia and Two or More Risk Factors","status":"WITHDRAWN","sponsor":"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran","startDate":"2009-11","conditions":"Cardiovascular Diseases, Hyperlipidemia","enrollment":""},{"nctId":"NCT00926055","phase":"NA","title":"Effects on Atherosclerosis Regression of Ezetimibe or Ezetimibe Plus Simvastatin; Evaluated by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)","status":"WITHDRAWN","sponsor":"Korea University","startDate":"2011-09","conditions":"Atherosclerosis","enrollment":""},{"nctId":"NCT01520077","phase":"PHASE1","title":"Vytorin in the Treatment of Alopecia Areata","status":"COMPLETED","sponsor":"University of Miami","startDate":"2011-07","conditions":"Alopecia Areata","enrollment":29},{"nctId":"NCT01660945","phase":"PHASE4","title":"Vascular and Metabolic Effects of Vytorin","status":"COMPLETED","sponsor":"Gachon University Gil Medical Center","startDate":"2011-07","conditions":"Hypercholesterolemia","enrollment":204},{"nctId":"NCT02129231","phase":"PHASE2","title":"Statins for Oxidative Stress and Mitochondrial Function in Diabetic Polyneuropathy","status":"COMPLETED","sponsor":"University of Guadalajara","startDate":"2012-02","conditions":"Oxidative Stress, Diabetic Polyneuropathy","enrollment":74},{"nctId":"NCT00461630","phase":"PHASE3","title":"Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2007-01","conditions":"Cardiovascular Disease, Peripheral Arterial Disease, Diabetes Mellitus","enrollment":25673},{"nctId":"NCT00762164","phase":"PHASE4","title":"Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol","status":"COMPLETED","sponsor":"Bronx VA Medical Center","startDate":"2007-03","conditions":"Hypercholesterolemia","enrollment":34},{"nctId":"NCT01384058","phase":"PHASE4","title":"Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes","status":"COMPLETED","sponsor":"University Hospital Freiburg","startDate":"2007-11","conditions":"Diabetes Mellitus Type 2, Hypercholesterolemia","enrollment":41},{"nctId":"NCT00664469","phase":"PHASE3","title":"INdians Followed for INtensive Lipid Lowering Treatment and Its safetY","status":"TERMINATED","sponsor":"Sunnybrook Health Sciences Centre","startDate":"2007-08","conditions":"Hypercholesterolemia","enrollment":64},{"nctId":"NCT00525824","phase":"PHASE3","title":"12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2007-08","conditions":"Hypercholesterolemia, Coronary Heart Disease, Atherosclerosis","enrollment":1743},{"nctId":"NCT00474123","phase":"NA","title":"Antiplatelet and Anti-inflammatory Effects of Statins and Ezetimibe","status":"COMPLETED","sponsor":"University of Sao Paulo","startDate":"2006-01","conditions":"Stable Angina","enrollment":78},{"nctId":"NCT01103648","phase":"NA","title":"Effect of Simvastatin and Ezetimibe on Lipid and Inflammation","status":"COMPLETED","sponsor":"Federal University of São Paulo","startDate":"2005-06","conditions":"Prediabetes, Hypercholesterolemia, Inflammation","enrollment":50},{"nctId":"NCT00905905","phase":"PHASE4","title":"Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction","status":"COMPLETED","sponsor":"Brasilia Heart Study Group","startDate":"2009-05","conditions":"Myocardial Infarction","enrollment":40},{"nctId":"NCT00699023","phase":"PHASE4","title":"Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes","status":"COMPLETED","sponsor":"Federico II University","startDate":"2008-06","conditions":"Postprandial Lipemia, Type 2 Diabetes","enrollment":13},{"nctId":"NCT00861731","phase":"PHASE4","title":"Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy","status":"UNKNOWN","sponsor":"Azienda Ospedaliero Universitaria di Sassari","startDate":"2008-11","conditions":"Hypercholesterolemia, Chronic Nephropathy","enrollment":30},{"nctId":"NCT00753883","phase":"PHASE4","title":"Ezetrol Post-Marketing Study","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-07","conditions":"Hyperlipidemia","enrollment":40},{"nctId":"NCT00566267","phase":"PHASE2, PHASE3","title":"A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-04","conditions":"Hyperlipidemia","enrollment":58}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Inegy 10/20"],"phase":"marketed","status":"active","brandName":"Ezetimibe 10/Simvastatin 20","genericName":"Ezetimibe 10/Simvastatin 20","companyName":"University Hospital Freiburg","companyId":"university-hospital-freiburg","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination reduces cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting hepatic cholesterol synthesis (simvastatin). Used for Hypercholesterolemia and mixed dyslipidemia.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}