{"id":"placebo-to-ezetimibe","safety":{"commonSideEffects":[{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Arthralgia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ezetimibe selectively inhibits the NPC1L1 cholesterol transporter located on the brush border of the small intestine, reducing the absorption of dietary and biliary cholesterol. This leads to decreased plasma LDL cholesterol levels and increased hepatic cholesterol uptake. It is often used as an adjunct to statins or as monotherapy for cholesterol management.","oneSentence":"Ezetimibe inhibits cholesterol absorption in the small intestine by blocking the Niemann-Pick C1-Like 1 (NPC1L1) transporter.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:28:45.334Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypercholesterolemia (primary and secondary prevention of cardiovascular disease)"},{"name":"Adjunctive therapy to statins for LDL cholesterol reduction"}]},"trialDetails":[{"nctId":"NCT06450366","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-07-08","conditions":"Hypercholesterolemia","enrollment":301},{"nctId":"NCT07219602","phase":"PHASE3","title":"A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome","status":"RECRUITING","sponsor":"NewAmsterdam Pharma","startDate":"2025-12-11","conditions":"Lipidemia, Type 2 Diabetes (T2DM), Metabolic Syndrome (MetS)","enrollment":300},{"nctId":"NCT07442630","phase":"PHASE4","title":"Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides","status":"ACTIVE_NOT_RECRUITING","sponsor":"JW Pharmaceutical","startDate":"2023-08-21","conditions":"Hypercholesterolemia","enrollment":88},{"nctId":"NCT06317051","phase":"PHASE3","title":"Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Kirby Institute","startDate":"2024-12-16","conditions":"HIV Infections, Weight Gain","enrollment":300},{"nctId":"NCT06742853","phase":"PHASE1","title":"A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C.","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2024-12-20","conditions":"Dyslipidemia","enrollment":81},{"nctId":"NCT05763875","phase":"PHASE3","title":"Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2023-03-15","conditions":"Hypercholesterolemia","enrollment":350},{"nctId":"NCT06005597","phase":"PHASE3","title":"Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies","status":"COMPLETED","sponsor":"NewAmsterdam Pharma","startDate":"2024-03-01","conditions":"Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia","enrollment":407},{"nctId":"NCT04669041","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia Not Adequately Controlled on Statin Therapy","status":"COMPLETED","sponsor":"Sanofi","startDate":"2020-12-08","conditions":"Hypercholesterolemia","enrollment":305},{"nctId":"NCT06305559","phase":"PHASE3","title":"A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque","status":"RECRUITING","sponsor":"NewAmsterdam Pharma","startDate":"2024-05-16","conditions":"Lipidemia, Coronary Artery Disease, Plaque, Atherosclerotic","enrollment":300},{"nctId":"NCT05255094","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of AK102 in Patients With Hyperlipidemia","status":"COMPLETED","sponsor":"Akeso","startDate":"2021-11-03","conditions":"Hyperlipidemia","enrollment":464},{"nctId":"NCT05260411","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of AK102 Q6W in Patients With Hyperlipidemia","status":"COMPLETED","sponsor":"Akeso","startDate":"2022-01-26","conditions":"Hyperlipidemia","enrollment":246},{"nctId":"NCT05255458","phase":"PHASE3","title":"A Study to Evaluate the Long-term Efficacy and Safety of AK102 in Patients With Hyperlipidemia","status":"COMPLETED","sponsor":"Akeso","startDate":"2021-11-04","conditions":"Hyperlipidemia","enrollment":122},{"nctId":"NCT05930028","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2023-07-13","conditions":"Essential Hypertension, Primary Hypercholesterolemia","enrollment":148},{"nctId":"NCT00092651","phase":"PHASE3","title":"A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-09","conditions":"Hypercholesterolemia","enrollment":1398},{"nctId":"NCT00092586","phase":"PHASE3","title":"Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-09","conditions":"Hypercholesterolemia","enrollment":2904},{"nctId":"NCT00552097","phase":"PHASE3","title":"Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-06-01","conditions":"Atherosclerosis, Hypercholesterolemia, Hyperlipoproteinemia Type II","enrollment":720},{"nctId":"NCT00092664","phase":"PHASE3","title":"An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2003-01","conditions":"Hypercholesterolemia","enrollment":1104},{"nctId":"NCT00092820","phase":"PHASE3","title":"Sitosterolemia Extension Study (0653-004)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2001-02-12","conditions":"Lipid Metabolism, Inborn Errors, Heart Disease","enrollment":58},{"nctId":"NCT00092638","phase":"PHASE3","title":"An Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-804)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2003-05","conditions":"Hypercholesterolemia, Coronary Disease","enrollment":450},{"nctId":"NCT00092625","phase":"PHASE3","title":"Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-803)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2003-03","conditions":"Hypercholesterolemia, Coronary Disease","enrollment":442},{"nctId":"NCT00110435","phase":"PHASE3","title":"A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-05","conditions":"Type 2 Diabetes Mellitus, Hypercholesterolemia","enrollment":1229},{"nctId":"NCT00092807","phase":"PHASE3","title":"Sitosterolemia Extension Study (0653-003)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2001-02-12","conditions":"Lipid Metabolism, Inborn Errors, Heart Disease","enrollment":37},{"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":"NCT00092898","phase":"PHASE3","title":"An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2004-10","conditions":"Lipid Metabolism, Inborn Errors, Heart Disease","enrollment":30},{"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":"NCT05266586","phase":"PHASE2","title":"Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy","status":"COMPLETED","sponsor":"NewAmsterdam Pharma","startDate":"2022-03-09","conditions":"Dyslipidemias, High Cholesterol, Hypercholesterolemia","enrollment":119},{"nctId":"NCT00101439","phase":"PHASE3","title":"A Study to Evaluate the Effects of Ezetimibe (MK-0653) on the Postprandial (Following a Meal) Lipoprotein Response in Participants With Primary Hypercholesterolemia (High Cholesterol) (MK-0653-072)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-11-10","conditions":"Hypercholesterolemia","enrollment":58},{"nctId":"NCT00202878","phase":"PHASE3","title":"IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-10-17","conditions":"Hypercholesterolemia, Myocardial Infarction","enrollment":18144},{"nctId":"NCT01611883","phase":"PHASE4","title":"A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2012-07-02","conditions":"Hypercholesterolemia","enrollment":152},{"nctId":"NCT00867165","phase":"PHASE3","title":"Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2009-05-21","conditions":"Primary Hypercholesterolemia","enrollment":138},{"nctId":"NCT02741245","phase":"PHASE3","title":"A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2016-06-09","conditions":"Hypercholesterolemia","enrollment":321},{"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":"NCT02550288","phase":"PHASE3","title":"A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2015-09-29","conditions":"Hypercholesterolemia","enrollment":309},{"nctId":"NCT00092677","phase":"PHASE3","title":"An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2001-01","conditions":"Aortic Stenosis","enrollment":1873},{"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":"NCT00271817","phase":"PHASE3","title":"To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-12","conditions":"Hypercholesterolemia","enrollment":1220},{"nctId":"NCT03768427","phase":"PHASE3","title":"Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2019-05-27","conditions":"Hypercholesterolemia","enrollment":454},{"nctId":"NCT00418834","phase":"PHASE3","title":"Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2007-01","conditions":"Hypercholesterolemia","enrollment":1053},{"nctId":"NCT00276458","phase":"PHASE3","title":"To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-02","conditions":"Hypercholesterolemia","enrollment":196},{"nctId":"NCT03867110","phase":"PHASE3","title":"An Efficacy and Safety Study of Ezetimibe (MK-0653, SCH 58235) in Addition to Atorvastatin Compared to Placebo in Participants With Primary Hypercholesterolemia (MK-0653-013)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2000-03-06","conditions":"Hypercholesterolemia","enrollment":628},{"nctId":"NCT03882905","phase":"PHASE3","title":"A Study of SCH 58235 (Ezetimibe) When Added to Ongoing Therapy With a Statin in Participants With Primary Hypercholesterolemia, Known Coronary Heart Disease, or Multiple Cardiovascular Risk Factors (P02173)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2001-01-31","conditions":"Primary Hypercholesterolemia","enrollment":769},{"nctId":"NCT03882892","phase":"PHASE3","title":"Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2001-02-02","conditions":"Hypercholesterolemia","enrollment":400},{"nctId":"NCT03884452","phase":"PHASE3","title":"Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2000-05-03","conditions":"Familial Hypercholesterolemia","enrollment":50},{"nctId":"NCT03867318","phase":"PHASE3","title":"Efficacy and Safety Study of Ezetimibe (SCH 58235, MK-0653) in Addition to Atorvastatin in Participants With Coronary Heart Disease or Multiple Cardiovascular Risk Factors (P00693/MK-0653-030)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2000-04-24","conditions":"Hypercholesterolemia","enrollment":621},{"nctId":"NCT04770389","phase":"PHASE2","title":"Randomized Study of Obicetrapib in Combination With Ezetimibe","status":"COMPLETED","sponsor":"NewAmsterdam Pharma","startDate":"2021-02-23","conditions":"Dyslipidemias, High Cholesterol, Hypercholesterolemia","enrollment":112},{"nctId":"NCT01420328","phase":"NA","title":"To Study the Effect of Vytorin on Intracellular Lipid and Inflammation in Obese Subjects","status":"COMPLETED","sponsor":"University at Buffalo","startDate":"2011-05-01","conditions":"Inflammation","enrollment":20},{"nctId":"NCT05795517","phase":"PHASE2","title":"Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease（NAFLD）","status":"COMPLETED","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2023-04-26","conditions":"Hypercholesterolemia","enrollment":210},{"nctId":"NCT04289649","phase":"PHASE3","title":"K-924 Phase III Confirmatory Study","status":"COMPLETED","sponsor":"Kowa Company, Ltd.","startDate":"2020-04-02","conditions":"Hypercholesterolemia","enrollment":293},{"nctId":"NCT01308203","phase":"PHASE4","title":"Lipid Efficacy of the Extended Release Niacin/Laropiprant Combination in Patients With Cardiovascular Disease","status":"TERMINATED","sponsor":"Daniel A. Siniawski","startDate":"2011-10","conditions":"Coronary Artery Disease, Dyslipidemias","enrollment":32},{"nctId":"NCT05970679","phase":"PHASE3","title":"Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A","status":"COMPLETED","sponsor":"Daewon Pharmaceutical Co., Ltd.","startDate":"2022-08-17","conditions":"Hypercholesterolemia, Dyslipidemia","enrollment":252},{"nctId":"NCT03510884","phase":"PHASE3","title":"An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia","status":"COMPLETED","sponsor":"Sanofi","startDate":"2018-05-31","conditions":"Hypercholesterolaemia","enrollment":153},{"nctId":"NCT03933293","phase":"PHASE2","title":"A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH","status":"COMPLETED","sponsor":"Akeso","startDate":"2019-05-13","conditions":"Homozygous Familial Hypercholesterolemia","enrollment":10},{"nctId":"NCT04173793","phase":"PHASE2","title":"A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)","status":"COMPLETED","sponsor":"Akeso","startDate":"2019-11-18","conditions":"Heterozygous Familial Hypercholesterolemia","enrollment":109},{"nctId":"NCT01375777","phase":"PHASE2","title":"Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels","status":"COMPLETED","sponsor":"Amgen","startDate":"2011-07-06","conditions":"Hyperlipidemia","enrollment":411},{"nctId":"NCT01763866","phase":"PHASE3","title":"LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2","status":"COMPLETED","sponsor":"Amgen","startDate":"2013-01-15","conditions":"Hyperlipidemia","enrollment":2067},{"nctId":"NCT01763827","phase":"PHASE3","title":"Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2","status":"COMPLETED","sponsor":"Amgen","startDate":"2013-01-21","conditions":"Hyperlipidemia","enrollment":615},{"nctId":"NCT01375764","phase":"PHASE2","title":"Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects","status":"COMPLETED","sponsor":"Amgen","startDate":"2011-07-28","conditions":"Hyperlipidemia","enrollment":160},{"nctId":"NCT01516879","phase":"PHASE3","title":"Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study","status":"COMPLETED","sponsor":"Amgen","startDate":"2012-01-05","conditions":"Hypercholesterolemia","enrollment":905},{"nctId":"NCT05131997","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A","status":"COMPLETED","sponsor":"Addpharma Inc.","startDate":"2021-11-16","conditions":"Primary Hypercholesterolemia","enrollment":290},{"nctId":"NCT02971033","phase":"PHASE2","title":"Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C","status":"TERMINATED","sponsor":"VA Office of Research and Development","startDate":"2018-04-16","conditions":"Chronic Hepatitis C","enrollment":2},{"nctId":"NCT03847506","phase":"PHASE4","title":"Evaluate Efficacy and Safety of Ezetimibe/Rosuvastatin and Candesartan Cilexetil/Amlodipine Besylate Combination Tablets","status":"COMPLETED","sponsor":"HK inno.N Corporation","startDate":"2018-07-05","conditions":"Hypertension, Hyperlipidemia","enrollment":127},{"nctId":"NCT01492361","phase":"PHASE3","title":"A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin","status":"COMPLETED","sponsor":"Amarin Pharma Inc.","startDate":"2011-11","conditions":"Cardiovascular Diseases","enrollment":8179},{"nctId":"NCT02476006","phase":"PHASE3","title":"Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2015-06-23","conditions":"Hypercholesterolemia","enrollment":998},{"nctId":"NCT00651404","phase":"PHASE3","title":"Ezetimibe Plus Atorvastatin Versus Atorvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03406)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2004-01","conditions":"Hypercholesterolemia, Atherosclerosis","enrollment":137},{"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":"NCT00202904","phase":"PHASE4","title":"Effectiveness and Safety of Ezetimibe Added to Atorvastatin in Patients With High Cholesterol and Coronary Heart Disease (Study P03740)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-05","conditions":"Hypercholesterolemia, Coronary Heart Disease","enrollment":81},{"nctId":"NCT00319449","phase":"PHASE4","title":"Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-09","conditions":"Hypercholesterolemia, Coronary Arteriosclerosis","enrollment":22},{"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":"NCT01370603","phase":"PHASE3","title":"A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2011-09","conditions":"Hypercholesterolemia","enrollment":328},{"nctId":"NCT01370590","phase":"PHASE3","title":"A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2011-09","conditions":"Hypercholesterolemia","enrollment":406},{"nctId":"NCT04589351","phase":"PHASE3","title":"Kidney Fat in Type 2 Diabetes and the Effects of Ezetimibe","status":"UNKNOWN","sponsor":"Steno Diabetes Center Copenhagen","startDate":"2020-10-01","conditions":"Diabetes Mellitus, Type 2, Diabetic Kidney Disease","enrollment":60},{"nctId":"NCT04844996","phase":"EARLY_PHASE1","title":"Antilipidemic Ezetimibe Induces Regression of Endometriotic Explants in a Rat Model of Endometriosis","status":"COMPLETED","sponsor":"Mersin University","startDate":"2019-09-01","conditions":"Endometriosis","enrollment":18},{"nctId":"NCT00794677","phase":"PHASE4","title":"Effects of Ezetimibe on the Absorption of Oxidized Cholesterol","status":"COMPLETED","sponsor":"UCSF Benioff Children's Hospital Oakland","startDate":"2006-06","conditions":"Hypercholesterolemia","enrollment":26},{"nctId":"NCT01035320","phase":"PHASE4","title":"Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment","status":"COMPLETED","sponsor":"Karolinska Institutet","startDate":"2006-01","conditions":"Diabetes Mellitus, Impaired Renal Function","enrollment":39},{"nctId":"NCT04659525","phase":"PHASE4","title":"Evolocumab Plus Ezetimibe in Haemodialized Statin-intolerant Patients With Hypercholesterolemia","status":"UNKNOWN","sponsor":"Policlinico Casilino ASL RMB","startDate":"2020-11-01","conditions":"Hypercholesterolemia, CKD Stage 5, Chronic Kidney Disease Requiring Chronic Dialysis","enrollment":50},{"nctId":"NCT02634580","phase":"PHASE3","title":"Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4","status":"COMPLETED","sponsor":"Amgen","startDate":"2016-02-27","conditions":"Hypercholesterolemia","enrollment":61},{"nctId":"NCT01763905","phase":"PHASE3","title":"Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2","status":"COMPLETED","sponsor":"Amgen","startDate":"2013-01-24","conditions":"Hyperlipidemia","enrollment":307},{"nctId":"NCT01766713","phase":"PHASE2","title":"Ezetimibe Versus Placebo in the Treatment of Non-alcoholic Steatohepatitis","status":"COMPLETED","sponsor":"University of California, San Diego","startDate":"2013-01","conditions":"Non Alcoholic Steatohepatitis","enrollment":50},{"nctId":"NCT01709513","phase":"PHASE3","title":"Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)","status":"COMPLETED","sponsor":"Regeneron Pharmaceuticals","startDate":"2012-09-30","conditions":"Hypercholesterolemia","enrollment":314},{"nctId":"NCT04397653","phase":"PHASE4","title":"Evolocumab Plus Ezetimibe in High Risk Haemodialized Statin Intolerant Patients","status":"UNKNOWN","sponsor":"Policlinico Casilino ASL RMB","startDate":"2020-05-04","conditions":"Hypercholesterolemia, Chronic Kidney Disease Requiring Chronic Dialysis","enrollment":50},{"nctId":"NCT03001076","phase":"PHASE3","title":"Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)","status":"COMPLETED","sponsor":"Esperion Therapeutics, Inc.","startDate":"2016-11-29","conditions":"Hypercholesterolemia, Atherosclerosis, Statin Adverse Reaction","enrollment":269},{"nctId":"NCT03531905","phase":"PHASE2","title":"Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C","status":"COMPLETED","sponsor":"Esperion Therapeutics, Inc.","startDate":"2018-05-09","conditions":"Diabetes, Diabetes Mellitus, Type 2, Cholesterolemia","enrollment":242},{"nctId":"NCT03337308","phase":"PHASE3","title":"A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy","status":"COMPLETED","sponsor":"Esperion Therapeutics, Inc.","startDate":"2017-10-23","conditions":"Hyperlipidemias","enrollment":382},{"nctId":"NCT01730053","phase":"PHASE3","title":"Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)","status":"COMPLETED","sponsor":"Regeneron Pharmaceuticals","startDate":"2012-11-30","conditions":"Hypercholesterolemia","enrollment":305},{"nctId":"NCT03051100","phase":"PHASE2","title":"Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C","status":"COMPLETED","sponsor":"Esperion Therapeutics, Inc.","startDate":"2017-01-19","conditions":"Hypercholesterolemia","enrollment":63},{"nctId":"NCT00687076","phase":"PHASE4","title":"Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)","status":"COMPLETED","sponsor":"Baylor College of Medicine","startDate":"2004-04","conditions":"Peripheral Arterial Disease","enrollment":102},{"nctId":"NCT04161001","phase":"PHASE3","title":"Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451","status":"UNKNOWN","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2019-11-20","conditions":"Hypertension, Dyslipidemia","enrollment":237},{"nctId":"NCT02227784","phase":"PHASE3","title":"A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol","status":"TERMINATED","sponsor":"Eli Lilly and Company","startDate":"2014-10","conditions":"Hyperlipidemia","enrollment":366},{"nctId":"NCT02715726","phase":"PHASE3","title":"Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia","status":"COMPLETED","sponsor":"Sanofi","startDate":"2016-07-27","conditions":"Hypercholesterolemia","enrollment":615},{"nctId":"NCT00965055","phase":"PHASE3","title":"Ezetimibe in Patients Hypo-responsive to Statins","status":"TERMINATED","sponsor":"University of California, San Diego","startDate":"2009-09","conditions":"High Cholesterol, Coronary Artery Disease","enrollment":2},{"nctId":"NCT01218204","phase":"PHASE2","title":"A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-09-14","conditions":"Dyslipidaemias, Dyslipidemias","enrollment":287},{"nctId":"NCT02055976","phase":"PHASE2","title":"Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects","status":"COMPLETED","sponsor":"Pfizer","startDate":"2014-03","conditions":"Hypercholesterolemia","enrollment":218},{"nctId":"NCT02584504","phase":"PHASE3","title":"Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin","status":"COMPLETED","sponsor":"Sanofi","startDate":"2015-11-30","conditions":"Hypercholesterolemia","enrollment":163},{"nctId":"NCT01984424","phase":"PHASE3","title":"Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3","status":"COMPLETED","sponsor":"Amgen","startDate":"2013-12-10","conditions":"Hyperlipidemia","enrollment":511},{"nctId":"NCT03571087","phase":"PHASE3","title":"Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia","status":"COMPLETED","sponsor":"Hanlim Pharm. Co., Ltd.","startDate":"2014-09","conditions":"Primary Hypercholesterolemia","enrollment":374},{"nctId":"NCT02023879","phase":"PHASE3","title":"Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2013-12-16","conditions":"Hypercholesterolemia","enrollment":233},{"nctId":"NCT00863265","phase":"EARLY_PHASE1","title":"Phytosterols, Ezetimibe, and Cholesterol Metabolism","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2009-06","conditions":"Hypercholesterolemia, Coronary Heart Disease","enrollment":22}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":515,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Placebo to Ezetimibe","genericName":"Placebo to Ezetimibe","companyName":"Amgen","companyId":"amgen","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ezetimibe inhibits cholesterol absorption in the small intestine by blocking the Niemann-Pick C1-Like 1 (NPC1L1) transporter. Used for Hypercholesterolemia (primary and secondary prevention of cardiovascular disease), Adjunctive therapy to statins for LDL cholesterol reduction.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":4,"withResults":4},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}