{"id":"fimasartan-amlodipine-combination","safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Peripheral edema"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Hyperkalemia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fimasartan is an angiotensin II receptor blocker (ARB) that prevents angiotensin II from binding to AT1 receptors, reducing vasoconstriction and aldosterone secretion. Amlodipine is a dihydropyridine calcium channel blocker that inhibits L-type calcium channels in vascular smooth muscle, causing vasodilation. The combination provides complementary mechanisms for blood pressure reduction.","oneSentence":"Fimasartan blocks angiotensin II receptors to lower blood pressure, while amlodipine blocks calcium channels to relax blood vessels, providing dual antihypertensive action.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:40.137Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension"}]},"trialDetails":[{"nctId":"NCT03991442","phase":"PHASE3","title":"BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2019-06-17","conditions":"Essential Hypertension","enrollment":257},{"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":"NCT03629067","phase":"PHASE1","title":"Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2018-09-13","conditions":"Pharmacokinetics","enrollment":60},{"nctId":"NCT03390465","phase":"PHASE1","title":"Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2017-12-15","conditions":"Drug-Drug Interaction","enrollment":36},{"nctId":"NCT02920047","phase":"PHASE1","title":"A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2016-10","conditions":"Hypertension","enrollment":60},{"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":"NCT01518998","phase":"PHASE2","title":"A Randomized, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2011-08","conditions":"Hypertension","enrollment":420},{"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":"NCT02152306","phase":"PHASE3","title":"Fimasartan/Amlodipine Combination Phase III","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2014-04","conditions":"Essential Hypertension","enrollment":143},{"nctId":"NCT02205151","phase":"PHASE1","title":"To Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2014-07","conditions":"Hypertension","enrollment":86}],"_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":["BR1010 or placebo"],"phase":"phase_3","status":"active","brandName":"Fimasartan/Amlodipine combination","genericName":"Fimasartan/Amlodipine combination","companyName":"Boryung Pharmaceutical Co., Ltd","companyId":"boryung-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fimasartan blocks angiotensin II receptors to lower blood pressure, while amlodipine blocks calcium channels to relax blood vessels, providing dual antihypertensive action. Used for Hypertension.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}