{"id":"fimasartan-and-amlodipine","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 calcium influx into vascular smooth muscle cells, causing vasodilation. The combination provides complementary mechanisms for blood pressure reduction.","oneSentence":"Fimasartan blocks angiotensin II receptors to lower blood pressure, while amlodipine relaxes blood vessels by blocking calcium channels, providing dual antihypertensive action.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:40.127Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension"}]},"trialDetails":[{"nctId":"NCT07262710","phase":"","title":"Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study","status":"NOT_YET_RECRUITING","sponsor":"First Teaching Hospital of Tianjin University of Traditional Chinese Medicine","startDate":"2025-12-01","conditions":"Post-stroke Pneumonia","enrollment":13656},{"nctId":"NCT05413057","phase":"","title":"An OS to Evaluate Effectiveness and Safety of Fixed-dose Combinations of FMS/AML or FMS/AML/HCTZ","status":"RECRUITING","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2022-06-23","conditions":"Hypertension,Essential","enrollment":20000},{"nctId":"NCT05173025","phase":"PHASE4","title":"Effect of Fimasartan on Extended RAS and Vascular Functions in Patients With Type 2 Diabetes and Hypertension","status":"UNKNOWN","sponsor":"Seoul National University Bundang Hospital","startDate":"2018-01-01","conditions":"Hypertension, Atherosclerosis, Diabetes Mellitus, Type 2","enrollment":42},{"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":"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":"NCT03294070","phase":"PHASE4","title":"Fimasartan Plus Amlodipine on Hemodynamic Parameters and Arterial Stiffness in Patients With Hypertension","status":"UNKNOWN","sponsor":"Centro Universitario de Ciencias de la Salud, Mexico","startDate":"2017-09","conditions":"Arterial Hypertension","enrollment":53},{"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":"NCT02312375","phase":"NA","title":"Effects of Fimasartan on Insulin Secretion in Type 2 Diabetic Patients","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2015-03","conditions":"Diabetes Mellitus, Hypertension","enrollment":46},{"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":"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},{"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},{"nctId":"NCT00938197","phase":"PHASE1","title":"A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2009-06","conditions":"Essential Hypertension","enrollment":34}],"_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 and Amlodipine","genericName":"Fimasartan and Amlodipine","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 relaxes blood vessels by blocking calcium channels, 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}}