{"id":"omacor-simvastatin","safety":{"commonSideEffects":[{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Elevated liver enzymes"},{"rate":null,"effect":"Gastrointestinal upset"},{"rate":null,"effect":"Rhabdomyolysis (rare)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Omacor is a prescription-strength omega-3 polyunsaturated fatty acid (icosapent ethyl and docosahexaenoic acid) that reduces plasma triglycerides through multiple pathways including reduced hepatic VLDL production. Simvastatin is a statin that competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol and cardiovascular risk. The combination addresses multiple lipid abnormalities in dyslipidemic patients.","oneSentence":"Omacor (omega-3 fatty acids) reduces triglycerides and supports cardiovascular health, while simvastatin lowers LDL cholesterol by inhibiting HMG-CoA reductase.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:58:14.783Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertriglyceridemia in patients requiring statin therapy"},{"name":"Dyslipidemia with elevated triglycerides and LDL cholesterol"}]},"trialDetails":[{"nctId":"NCT00678743","phase":"PHASE4","title":"An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin","status":"COMPLETED","sponsor":"Provident Clinical Research","startDate":"2007-08","conditions":"Dyslipidemias","enrollment":17},{"nctId":"NCT00743197","phase":"NA","title":"Women With Chest Pain and Normal Coronary Arteries Study","status":"TERMINATED","sponsor":"Northwestern University","startDate":"2008-05","conditions":"Chest Pain","enrollment":3},{"nctId":"NCT01047501","phase":"PHASE3","title":"Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)","status":"COMPLETED","sponsor":"Amarin Pharma Inc.","startDate":"2009-12","conditions":"Hypertriglyceridemia","enrollment":702},{"nctId":"NCT01047683","phase":"PHASE3","title":"Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL","status":"COMPLETED","sponsor":"Amarin Pharma Inc.","startDate":"2009-12","conditions":"Hypertriglyceridemia","enrollment":229},{"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":"NCT00903409","phase":"PHASE3","title":"Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-11-15","conditions":"Hypertriglyceridemia","enrollment":188},{"nctId":"NCT00246701","phase":"PHASE3","title":"Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-11-01","conditions":"Hypertriglyceridemia","enrollment":256},{"nctId":"NCT02305355","phase":"PHASE4","title":"Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia","status":"COMPLETED","sponsor":"Kuhnil Pharmaceutical Co., Ltd.","startDate":"2009-02","conditions":"Diabetes Mellitus, Type 2, Hypertriglycemia","enrollment":68},{"nctId":"NCT01086163","phase":"","title":"Effects of Omega-3 Fatty Acids on Platelets in Patients With Coronary Artery Disease With Hypertriglyceridemia","status":"UNKNOWN","sponsor":"HeartDrug Research LLC","startDate":"2010-10","conditions":"Coronary Artery Disease","enrollment":30},{"nctId":"NCT00487591","phase":"","title":"An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia","status":"COMPLETED","sponsor":"Provident Clinical Research","startDate":"2006-11","conditions":"Mixed Dyslipidemia","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Omega-3-acid ethyl esters","Lovaza","Zocor"],"phase":"marketed","status":"active","brandName":"Omacor + simvastatin","genericName":"Omacor + simvastatin","companyName":"Provident Clinical Research","companyId":"provident-clinical-research","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Omacor (omega-3 fatty acids) reduces triglycerides and supports cardiovascular health, while simvastatin lowers LDL cholesterol by inhibiting HMG-CoA reductase. Used for Hypertriglyceridemia in patients requiring statin therapy, Dyslipidemia with elevated triglycerides and LDL cholesterol.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}