{"id":"irbesartan-and-irbesartan-hydrochlorothiazide","safety":{"commonSideEffects":[{"rate":"9-10","effect":"Dizziness"},{"rate":"3-4","effect":"Fatigue"},{"rate":"7-8","effect":"Musculoskeletal pain"},{"rate":"1-2","effect":"Hyperkalemia"},{"rate":"1-3","effect":"Hypotension"},{"rate":"2-4","effect":"Hypokalemia (with combination formulation)"},{"rate":"null","effect":"Hyperuricemia (with thiazide component)"}]},"_chembl":{"chemblId":"CHEMBL1513","moleculeType":"Small molecule","molecularWeight":"428.54"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Irbesartan is an angiotensin II receptor blocker (ARB) that selectively antagonizes AT1 receptors, preventing angiotensin II-mediated vasoconstriction and aldosterone release. Hydrochlorothiazide enhances this effect by inhibiting sodium reabsorption in the distal convoluted tubule, reducing blood volume and further lowering blood pressure. The combination provides complementary mechanisms for improved antihypertensive efficacy.","oneSentence":"Irbesartan blocks angiotensin II type 1 receptors to relax blood vessels and lower blood pressure; the combination formulation adds hydrochlorothiazide, a thiazide diuretic that reduces fluid volume.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:50:14.525Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension (irbesartan monotherapy and combination)"},{"name":"Diabetic nephropathy in patients with type 2 diabetes and hypertension (irbesartan monotherapy)"}]},"trialDetails":[{"nctId":"NCT06790927","phase":"NA","title":"Standardized Antihypertensive Treatment Protocol","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Jiao Tong University School of Medicine","startDate":"2025-02-24","conditions":"Hypertension","enrollment":400},{"nctId":"NCT04467931","phase":"","title":"ACEI or ARB and COVID-19 Severity and Mortality in US Veterans","status":"COMPLETED","sponsor":"University of Utah","startDate":"2020-01-19","conditions":"Hypertension, COVID","enrollment":22213},{"nctId":"NCT03006796","phase":"","title":"Observational Study of Azilsartan/Chlorthalidone and Irbesartan/Hydrochlorothiazide in Hypertension and Obesity.","status":"COMPLETED","sponsor":"Russian Heart Failure Society","startDate":"2017-01-16","conditions":"Arterial Hypertension","enrollment":94},{"nctId":"NCT00535925","phase":"PHASE4","title":"Nephropathy In Type 2 Diabetes and Cardio-renal Events","status":"COMPLETED","sponsor":"University of Campania Luigi Vanvitelli","startDate":"2005-10","conditions":"Diabetic Nephropathy","enrollment":850},{"nctId":"NCT04330300","phase":"PHASE4","title":"Coronavirus (COVID-19) ACEi/ARB Investigation","status":"SUSPENDED","sponsor":"National University of Ireland, Galway, Ireland","startDate":"2020-04-30","conditions":"Hypertension, COVID-19","enrollment":2414},{"nctId":"NCT01712126","phase":"NA","title":"Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions","status":"COMPLETED","sponsor":"Roxane Laboratories","startDate":"2007-09","conditions":"Hypertension","enrollment":40},{"nctId":"NCT01712139","phase":"NA","title":"Crossover Bioequivalence Study of Irbesartan HCTZ 300/25 mg Tablets Under Fasted Conditions","status":"COMPLETED","sponsor":"Roxane Laboratories","startDate":"2007-09","conditions":"Hypertension","enrollment":37},{"nctId":"NCT00219115","phase":"PHASE3","title":"A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-01","conditions":"Hypertension","enrollment":493},{"nctId":"NCT01858610","phase":"NA","title":"Drug Interaction Between Irbesartan and Hydrochlorothiazide","status":"COMPLETED","sponsor":"Damanhour University","startDate":"2013-03","conditions":"Healthy","enrollment":18},{"nctId":"NCT00713011","phase":"PHASE3","title":"Adalat XL vs Diltiazem on Proteinuria and Blood Pressure in Hypertensive Diabetic Patients","status":"WITHDRAWN","sponsor":"Bayer","startDate":"2008-11","conditions":"Diabetic Nephropathies, Hypertension","enrollment":""},{"nctId":"NCT00095394","phase":"PHASE3","title":"Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2004-09","conditions":"Hypertension","enrollment":645},{"nctId":"NCT00095550","phase":"PHASE3","title":"Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2004-10","conditions":"Hypertension","enrollment":496},{"nctId":"NCT00224549","phase":"PHASE4","title":"PHARES Study: Management of Resistant Hypertension","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2005-04","conditions":"Hypertension","enrollment":180},{"nctId":"NCT00500604","phase":"PHASE4","title":"Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension","status":"COMPLETED","sponsor":"Sanofi","startDate":"2007-07","conditions":"Hypertension","enrollment":1617},{"nctId":"NCT00708344","phase":"PHASE4","title":"ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination","status":"COMPLETED","sponsor":"Sanofi","startDate":"2008-06","conditions":"Hypertension","enrollment":832},{"nctId":"NCT00443612","phase":"PHASE4","title":"Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing","status":"COMPLETED","sponsor":"Sanofi","startDate":"2006-09","conditions":"Hypertension","enrollment":60},{"nctId":"NCT00670566","phase":"PHASE4","title":"Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients","status":"COMPLETED","sponsor":"Sanofi","startDate":"2008-04","conditions":"Hypertension","enrollment":503},{"nctId":"NCT00264212","phase":"PHASE4","title":"AMISH : Aprovel for Management of Isolated Systolic Hypertension","status":"COMPLETED","sponsor":"Sanofi","startDate":"2004-08","conditions":"Hypertension","enrollment":436},{"nctId":"NCT00263003","phase":"PHASE3","title":"Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension","status":"COMPLETED","sponsor":"Sanofi","startDate":"2005-06","conditions":"Hypertension","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":59,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"irbesartan and irbesartan-hydrochlorothiazide","genericName":"irbesartan and irbesartan-hydrochlorothiazide","companyName":"Sanofi","companyId":"sanofi","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Irbesartan blocks angiotensin II type 1 receptors to relax blood vessels and lower blood pressure; the combination formulation adds hydrochlorothiazide, a thiazide diuretic that reduces fluid volume. Used for Hypertension (irbesartan monotherapy and combination), Diabetic nephropathy in patients with type 2 diabetes and hypertension (irbesartan monotherapy).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}