{"id":"fimasartan-amlodipine-rosuvastatin","safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Peripheral edema"},{"rate":null,"effect":"Muscle pain or myalgia"},{"rate":null,"effect":"Elevated liver enzymes"}]},"_chembl":{"chemblId":"CHEMBL1951143","moleculeType":"Small molecule","molecularWeight":"501.66"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fimasartan blocks angiotensin II type 1 receptors to reduce vasoconstriction and aldosterone secretion, amlodipine inhibits L-type calcium channels in vascular smooth muscle to promote vasodilation, and rosuvastatin inhibits HMG-CoA reductase to decrease LDL cholesterol synthesis. Together, these three agents address multiple cardiovascular risk factors—hypertension and dyslipidemia—in a single formulation.","oneSentence":"This combination drug lowers blood pressure through angiotensin II receptor blockade and calcium channel inhibition, while simultaneously reducing cholesterol via HMG-CoA reductase inhibition.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:35.126Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension and dyslipidemia in patients requiring combination therapy"}]},"trialDetails":[{"nctId":"NCT03156842","phase":"PHASE3","title":"Combination of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2017-05-29","conditions":"Essential Hypertension, Dyslipidemia","enrollment":138},{"nctId":"NCT02378064","phase":"PHASE4","title":"Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation","status":"COMPLETED","sponsor":"CHEOL WHAN LEE, M.D., Ph.D","startDate":"2015-05","conditions":"Inflammation Plaque, Atherosclerotic, Coronary Disease, Renin-Angiotensin System","enrollment":50},{"nctId":"NCT02995720","phase":"PHASE1","title":"A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2016-08-26","conditions":"Hypertension, Hyperlipidemia","enrollment":60},{"nctId":"NCT02569814","phase":"PHASE1","title":"A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2015-09","conditions":"Hypertension, Hyperlipidemia","enrollment":100},{"nctId":"NCT02397538","phase":"PHASE1","title":"Study to Evaluate the Pharmacokinetic Interaction and Safety After Multiple Oral Doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2015-02","conditions":"Hypertension","enrollment":50}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"Fimasartan/Amlodipine, Rosuvastatin","genericName":"Fimasartan/Amlodipine, Rosuvastatin","companyName":"Boryung Pharmaceutical Co., Ltd","companyId":"boryung-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination drug lowers blood pressure through angiotensin II receptor blockade and calcium channel inhibition, while simultaneously reducing cholesterol via HMG-CoA reductase inhibition. Used for Hypertension and dyslipidemia in patients requiring combination therapy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}