{"id":"comparator-statins","safety":{"commonSideEffects":[{"rate":"1-3%","effect":"Muscle pain or myalgia"},{"rate":"1-3%","effect":"Elevated liver enzymes (ALT/AST)"},{"rate":"<0.1%","effect":"Rhabdomyolysis"},{"rate":"1-2%","effect":"Headache"},{"rate":"1-2%","effect":"Gastrointestinal upset"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Statins competitively block HMG-CoA reductase, which catalyzes the conversion of HMG-CoA to mevalonate in the cholesterol biosynthetic pathway. This leads to decreased hepatic cholesterol production, upregulation of LDL receptors on hepatocytes, and enhanced clearance of LDL from the bloodstream. The net effect is a reduction in circulating LDL cholesterol and associated cardiovascular risk.","oneSentence":"Statins inhibit HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:07:16.117Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypercholesterolemia and dyslipidemia"},{"name":"Primary and secondary prevention of cardiovascular disease"}]},"trialDetails":[{"nctId":"NCT07478328","phase":"PHASE2","title":"Chaigui Longmu Ejiao Paste for Ischemic Heart Disease","status":"NOT_YET_RECRUITING","sponsor":"Longhua Hospital","startDate":"2026-03-08","conditions":"Ischemic Heart Disease","enrollment":60},{"nctId":"NCT04894877","phase":"","title":"ISCHEMIA-EXTEND (Extended Follow-up)","status":"ACTIVE_NOT_RECRUITING","sponsor":"NYU Langone Health","startDate":"2012-07","conditions":"Cardiovascular Diseases, Coronary Disease, Coronary Artery Disease","enrollment":5391},{"nctId":"NCT05764057","phase":"PHASE3","title":"DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2023-06-12","conditions":"AMI, STEMI, NSTEMI","enrollment":450},{"nctId":"NCT06789588","phase":"PHASE3","title":"Protocol for Improvement of Therapy With Warfarin","status":"ENROLLING_BY_INVITATION","sponsor":"University of Pernambuco","startDate":"2024-10-21","conditions":"Atrial Fibrillation (AF)","enrollment":700},{"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":"NCT00132717","phase":"PHASE3","title":"A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-01-01","conditions":"Hypercholesterolemia","enrollment":450},{"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":"NCT00395603","phase":"PHASE3","title":"Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)","status":"TERMINATED","sponsor":"Organon and Co","startDate":"2006-09","conditions":"Cardiovascular Diseases, Diabetes Mellitus","enrollment":550},{"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":"NCT06338241","phase":"PHASE4","title":"Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model","status":"RECRUITING","sponsor":"Mario Pérez Sayáns","startDate":"2024-03-02","conditions":"Bone Loss, Regenerative Inflammation","enrollment":30},{"nctId":"NCT02993406","phase":"PHASE3","title":"Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo","status":"COMPLETED","sponsor":"Esperion Therapeutics, Inc.","startDate":"2016-12-22","conditions":"Cardiovascular Diseases, Statin Adverse Reaction","enrollment":13970},{"nctId":"NCT03273972","phase":"NA","title":"INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers","status":"COMPLETED","sponsor":"Cambridge University Hospitals NHS Foundation Trust","startDate":"2017-09-07","conditions":"Atherosclerosis, Cardiovascular Diseases","enrollment":30},{"nctId":"NCT03837925","phase":"PHASE3","title":"Pharmaco-metabolomic Effects of Statins: METASTATINE","status":"COMPLETED","sponsor":"French Cardiology Society","startDate":"2019-06-13","conditions":"Cardiovascular Diseases","enrollment":120},{"nctId":"NCT05613400","phase":"PHASE4","title":"Statin and Bone Health","status":"UNKNOWN","sponsor":"The University of Hong Kong","startDate":"2022-04-13","conditions":"Diabetes Mellitus, Type 2","enrollment":240},{"nctId":"NCT04631536","phase":"PHASE3","title":"Managing Endothelial Dysfunction in COVID-19 : A Randomized Controlled Trial at LAUMC","status":"UNKNOWN","sponsor":"Lebanese American University Medical Center","startDate":"2021-01-10","conditions":"Covid19","enrollment":42},{"nctId":"NCT01508468","phase":"PHASE3","title":"Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2012-01-17","conditions":"Idiopathic Membranous Nephropathy","enrollment":80},{"nctId":"NCT00959842","phase":"PHASE1, PHASE2","title":"Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia","status":"COMPLETED","sponsor":"Sanford Research","startDate":"2009-09","conditions":"Hypertriglyceridemia","enrollment":15},{"nctId":"NCT03355027","phase":"NA","title":"Investigating the Lowest Threshold of Vascular Benefits From LDL Cholesterol Lowering in Patients With Stable CV Disease","status":"UNKNOWN","sponsor":"Cambridge University Hospitals NHS Foundation Trust","startDate":"2017-11-30","conditions":"Atherosclerosis, Cardiovascular Diseases","enrollment":60},{"nctId":"NCT01859455","phase":"PHASE1","title":"Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2011-07","conditions":"Hypercholesterolemia, LDL Cholesterol","enrollment":25},{"nctId":"NCT03507374","phase":"EARLY_PHASE1","title":"PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis","status":"TERMINATED","sponsor":"University of Utah","startDate":"2018-10-30","conditions":"Stroke, Intracranial Atherosclerosis, Intraplaque Hemorrhage","enrollment":20},{"nctId":"NCT03640221","phase":"PHASE4","title":"Ertugliflozin Versus Hydrochlorothiazide in Reducing Sympathetic Neural Overactivity in Patients With Hypertension and Recently-diagnosed Type 2 Diabetes.","status":"WITHDRAWN","sponsor":"Cedars-Sinai Medical Center","startDate":"2018-09-01","conditions":"Hypertension, Diabetes Mellitus, Type 2","enrollment":""},{"nctId":"NCT00685776","phase":"PHASE3","title":"Study to Assess the Tolerability and Efficacy of Anacetrapib in Patients With Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease (MK-0859-019)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2008-03-24","conditions":"Coronary Heart Disease (CHD), CHD Risk-Equivalent Disease","enrollment":1623},{"nctId":"NCT00485758","phase":"PHASE3","title":"Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2007-07","conditions":"Diabetes Mellitus Type 2","enrollment":796},{"nctId":"NCT00701883","phase":"PHASE2","title":"Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2007-08","conditions":"Hyperlipidemia","enrollment":183},{"nctId":"NCT00990808","phase":"PHASE1","title":"The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-11","conditions":"Dyslipidemia","enrollment":46},{"nctId":"NCT00479388","phase":"PHASE3","title":"Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2007-07","conditions":"Primary Hypercholesterolemia, Mixed Dyslipidemia","enrollment":1216},{"nctId":"NCT01408303","phase":"PHASE3","title":"[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2011-08","conditions":"Hypertriglyceridemia, Cardiovascular Disease","enrollment":646},{"nctId":"NCT01979601","phase":"PHASE1","title":"Safety, Tolerability, PK and PD of LGT209 in Healthy Volunteers and Patients With Hypercholesterolemia","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2010-12","conditions":"Hypercholesterolemia","enrollment":74},{"nctId":"NCT01279590","phase":"PHASE2","title":"Study of the Safety and Tolerability Associated With PPD10558 Versus Atorvastatin in Patients Previously Intolerant to Statins Due to Statin-associated Myalgia (SAM)","status":"COMPLETED","sponsor":"Furiex Pharmaceuticals, Inc","startDate":"2011-03","conditions":"Myalgia, Hypercholesterolemia, Hyperlipidemia","enrollment":282},{"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":"NCT01173939","phase":"NA","title":"Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments","status":"TERMINATED","sponsor":"Positive Trial Group","startDate":"2010-07","conditions":"Hypercholesterolemia, Type 2 Diabetes, Hypertension","enrollment":10000},{"nctId":"NCT01325818","phase":"PHASE4","title":"The Effects of Pravastatin and Rosuvastatin on Coronary Plaques in Patients With Stable Angina Pectoris","status":"UNKNOWN","sponsor":"Yokohama City University Medical Center","startDate":"2011-03","conditions":"Coronary Disease, Hypercholesterolemia","enrollment":150},{"nctId":"NCT00145574","phase":"PHASE4","title":"Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol","status":"COMPLETED","sponsor":"Daiichi Sankyo","startDate":"2005-11","conditions":"Hypercholesterolemia","enrollment":194}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":12,"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":"Comparator: statins","genericName":"Comparator: statins","companyName":"Organon and Co","companyId":"organon-and-co","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Statins inhibit HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels. Used for Hypercholesterolemia and dyslipidemia, Primary and secondary prevention of cardiovascular disease.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}