{"id":"losartan-hydrochlorothiazide-in-fixed-dose","safety":{"commonSideEffects":[{"rate":"5-10","effect":"Dizziness"},{"rate":"3-5","effect":"Fatigue"},{"rate":"2-5","effect":"Hyperkalemia (losartan component)"},{"rate":"5-10","effect":"Hypokalemia (hydrochlorothiazide component)"},{"rate":"3-5","effect":"Hyperuricemia"},{"rate":"1-2","effect":"Cough"},{"rate":"5-8","effect":"Headache"},{"rate":"2-4","effect":"Hypotension"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Losartan is an angiotensin II receptor antagonist (ARB) that prevents angiotensin II from binding to AT1 receptors on blood vessels and the adrenal gland, causing vasodilation and reduced aldosterone secretion. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium reabsorption in the distal convoluted tubule, increasing urinary sodium and water loss. The combination provides complementary antihypertensive effects through different mechanisms.","oneSentence":"Losartan blocks angiotensin II receptors to reduce vasoconstriction, while hydrochlorothiazide promotes sodium and water excretion to lower blood volume, together reducing blood pressure.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:19:28.176Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension (essential hypertension)"},{"name":"Reduction of cardiovascular morbidity and mortality in hypertensive patients at high risk"}]},"trialDetails":[{"nctId":"NCT04927299","phase":"PHASE3","title":"Efficacy and Safety of Losartan/Chlorthalidone vs Losartan/Hydrochlorothiazide in Essential Arterial Hypertension","status":"COMPLETED","sponsor":"Laboratorios Silanes S.A. de C.V.","startDate":"2022-06-30","conditions":"Essential Arterial Hypertension","enrollment":163},{"nctId":"NCT00140959","phase":"PHASE4","title":"Losartan and HCTZ and Amlodipine vs Atenolol and Amlodipine (0954A-309)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2003-02-01","conditions":"Hypertension","enrollment":120},{"nctId":"NCT02278471","phase":"PHASE2","title":"The SCCS Polypill Pilot Trial","status":"COMPLETED","sponsor":"Vanderbilt University","startDate":"2015-12","conditions":"Hypertension, Hyperlipidemia","enrollment":303},{"nctId":"NCT01218724","phase":"PHASE1","title":"Bioequivalence Study of Losartan Potassium and Hydrochlorothiazide (100 mg / 25 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Hyzaar® (100 mg / 25 mg Tablet) [Reference Formulation, Merck & Co., Inc., USA] in Healthy Human Volunteers Under Fed Conditions","status":"COMPLETED","sponsor":"Torrent Pharmaceuticals Limited","startDate":"","conditions":"Healthy","enrollment":""},{"nctId":"NCT01218711","phase":"PHASE1","title":"Bioequivalence Study of Losartan Potassium and Hydrochlorothiazide (100 mg / 25 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Hyzaar® (100 mg / 25 mg Tablet) [Reference Formulation, Merck & Co., Inc., USA] in Healthy Human Volunteers Under Fasting Conditions.","status":"COMPLETED","sponsor":"Torrent Pharmaceuticals Limited","startDate":"","conditions":"Healthy","enrollment":""},{"nctId":"NCT02521246","phase":"PHASE3","title":"Efficacy and Safety of Candesartan Associated With Chlorthalidone Versus Losartan Associated With Hydrochlorothiazide (Hyzaar®) in Essential Hypertension Control","status":"WITHDRAWN","sponsor":"EMS","startDate":"2016-11","conditions":"Essential Arterial Hypertension","enrollment":""},{"nctId":"NCT02521233","phase":"PHASE3","title":"Efficacy and Safety of Candesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control","status":"WITHDRAWN","sponsor":"EMS","startDate":"2016-11","conditions":"Essential Arterial Hypertension","enrollment":""},{"nctId":"NCT00492128","phase":"PHASE4","title":"Kanagawa Combination Anti-hypertensive Therapy (K-CAT)","status":"COMPLETED","sponsor":"Yokohama City University Medical Center","startDate":"2007-09","conditions":"Hypertension","enrollment":196},{"nctId":"NCT02183701","phase":"PHASE3","title":"Telmisartan Compared to Losartan + Hydrochlorothiazide in Patients With Mild-to-moderate Essential Hypertension","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"1998-04","conditions":"Hypertension","enrollment":715}],"_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":["LOS/HYDROCHLO"],"phase":"phase_3","status":"active","brandName":"Losartan + hydrochlorothiazide in fixed dose","genericName":"Losartan + hydrochlorothiazide in fixed dose","companyName":"Laboratorios Silanes S.A. de C.V.","companyId":"laboratorios-silanes-s-a-de-c-v","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Losartan blocks angiotensin II receptors to reduce vasoconstriction, while hydrochlorothiazide promotes sodium and water excretion to lower blood volume, together reducing blood pressure. Used for Hypertension (essential hypertension), Reduction of cardiovascular morbidity and mortality in hypertensive patients at high risk.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}