{"id":"amlodipine-besylate-benazepril-hydrochloride","safety":{"commonSideEffects":[{"rate":"5-10","effect":"Headache"},{"rate":"3-8","effect":"Dizziness"},{"rate":"2-5","effect":"Fatigue"},{"rate":"2-5","effect":"Peripheral edema"},{"rate":"1-3","effect":"Cough"},{"rate":"1-2","effect":"Hyperkalemia"},{"rate":"<1","effect":"Angioedema"}]},"_chembl":{"chemblId":"CHEMBL1200402","moleculeType":"Small molecule","molecularWeight":"567.06"},"_dailymed":{"setId":"ff807933-7433-4f8c-9d09-02a57e51d0fc","title":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Amlodipine is a calcium channel blocker that prevents calcium from entering vascular smooth muscle cells, causing vasodilation. Benazepril is an ACE inhibitor that blocks the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor, thereby reducing peripheral vascular resistance and blood pressure. Together, these complementary mechanisms provide additive antihypertensive effects.","oneSentence":"This combination drug lowers blood pressure by relaxing blood vessels (amlodipine) and reducing angiotensin II production (benazepril).","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T05:54:18.510Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension"}]},"trialDetails":[{"nctId":"NCT07486453","phase":"PHASE1","title":"Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets","status":"NOT_YET_RECRUITING","sponsor":"Shenzhen Salubris Pharmaceuticals Co., Ltd.","startDate":"2026-03-09","conditions":"Primary Hypertension","enrollment":60},{"nctId":"NCT00170950","phase":"PHASE3","title":"Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension","status":"TERMINATED","sponsor":"Novartis","startDate":"2003-10","conditions":"Hypertension","enrollment":11506},{"nctId":"NCT01505998","phase":"PHASE1","title":"Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2007-03","conditions":"Fed","enrollment":49},{"nctId":"NCT01506011","phase":"PHASE1","title":"Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fasting Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2007-03","conditions":"Fasting","enrollment":50},{"nctId":"NCT00136851","phase":"PHASE4","title":"Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2004-12","conditions":"Hypertension","enrollment":259},{"nctId":"NCT00367978","phase":"PHASE4","title":"Effects of Amlodipine/Benazepril in the Hypertensive African-American Population With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Novartis","startDate":"2001-12","conditions":"Hypertension","enrollment":275},{"nctId":"NCT01375322","phase":"PHASE4","title":"ADDM Study - Amtrel and Co-Diovan in Type 2 Diabetes Mellitus Hypertension Patients With Microalbuminuria","status":"COMPLETED","sponsor":"TSH Biopharm Corporation Limited","startDate":"2007-06","conditions":"Hypertension, Diabetes Mellitus, Type 2, Albuminuria","enrollment":226},{"nctId":"NCT01155908","phase":"PHASE1","title":"Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2005-04","conditions":"Healthy","enrollment":48},{"nctId":"NCT01155895","phase":"PHASE1","title":"Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2004-03","conditions":"Healthy","enrollment":54}],"_emaApprovals":[],"_faersSignals":[{"count":62,"reaction":"FATIGUE"},{"count":53,"reaction":"DRUG INEFFECTIVE"},{"count":46,"reaction":"NAUSEA"},{"count":40,"reaction":"DIARRHOEA"},{"count":40,"reaction":"OFF LABEL USE"},{"count":40,"reaction":"PAIN"},{"count":37,"reaction":"DIZZINESS"},{"count":36,"reaction":"PRODUCT DOSE OMISSION ISSUE"},{"count":32,"reaction":"PRURITUS"},{"count":31,"reaction":"DYSPNOEA"}],"_approvalHistory":[],"publicationCount":7,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Lotrel® (10 mg Amlodipine Besylate / 20 mg Benazepril","Hydrochloride Capsules)"],"phase":"marketed","status":"active","brandName":"Amlodipine Besylate / Benazepril Hydrochloride","genericName":"Amlodipine Besylate / Benazepril Hydrochloride","companyName":"Dr. Reddy's Laboratories Limited","companyId":"dr-reddy-s-laboratories-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination drug lowers blood pressure by relaxing blood vessels (amlodipine) and reducing angiotensin II production (benazepril). 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}}