{"id":"aliskiren-hctz-amlodipine-phase-3","safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Hyperkalemia (elevated potassium)"},{"rate":null,"effect":"Hypotension"},{"rate":null,"effect":"Peripheral edema"},{"rate":null,"effect":"Cough"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Aliskiren is a direct renin inhibitor that blocks the first step of the renin-angiotensin-aldosterone system. Hydrochlorothiazide (HCTZ) is a thiazide diuretic that reduces blood volume and sodium reabsorption. Amlodipine is a calcium channel blocker that causes vasodilation. Together, these three agents provide complementary antihypertensive effects targeting different pathways of blood pressure regulation.","oneSentence":"This triple-combination drug lowers blood pressure by blocking the renin-angiotensin system (aliskiren), reducing fluid volume (HCTZ), and relaxing blood vessels (amlodipine).","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:00:45.490Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension (high blood pressure)"}]},"trialDetails":[{"nctId":"NCT01070030","phase":"PHASE4","title":"Efficacy and Safety of Combination Therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Stage II Hypertension","status":"COMPLETED","sponsor":"Novartis","startDate":"2010-01","conditions":"Stage II Hypertension","enrollment":230},{"nctId":"NCT01922141","phase":"PHASE4","title":"Aliskiren Study of Safety and Efficacy in Senior Hypertensives","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2015-05","conditions":"Hypertension","enrollment":""},{"nctId":"NCT00867490","phase":"PHASE3","title":"Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension","status":"COMPLETED","sponsor":"Novartis","startDate":"2009-03","conditions":"Hypertension","enrollment":186}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":28734,"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":"Aliskiren+HCTZ+amlodipine - Phase 3","genericName":"Aliskiren+HCTZ+amlodipine - Phase 3","companyName":"Novartis","companyId":"novartis","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This triple-combination drug lowers blood pressure by blocking the renin-angiotensin system (aliskiren), reducing fluid volume (HCTZ), and relaxing blood vessels (amlodipine). Used for Hypertension (high blood pressure).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}