{"id":"azilsartan-medoxomil-and-olmesartan","safety":{"commonSideEffects":[{"rate":null,"effect":"Hyperkalemia"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Hypotension"},{"rate":null,"effect":"Renal impairment"}]},"_chembl":{"chemblId":"CHEMBL1200692","moleculeType":"Small molecule","molecularWeight":"558.60"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Azilsartan medoxomil is a prodrug that is hydrolyzed to azilsartan, an ARB with high affinity and selectivity for the AT1 receptor. Olmesartan is also an ARB targeting the same receptor. The combination aims to provide enhanced or complementary antihypertensive and renoprotective effects through dual ARB therapy, though such combinations are not standard clinical practice and this appears to be an investigational approach.","oneSentence":"This combination of two angiotensin II receptor blockers (ARBs) blocks the angiotensin II type 1 receptor to reduce blood pressure and provide cardiovascular protection.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:03:17.587Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension (investigational combination therapy)"}]},"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":"NCT05498675","phase":"","title":"Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study","status":"RECRUITING","sponsor":"Beijing Friendship Hospital","startDate":"2021-09-01","conditions":"Sacubitril/Valsartan, Hypertension, Obesity","enrollment":180},{"nctId":"NCT04606563","phase":"PHASE3","title":"Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?","status":"TERMINATED","sponsor":"University of British Columbia","startDate":"2020-10-09","conditions":"Covid19, SARS-CoV Infection","enrollment":341},{"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":"NCT04743063","phase":"","title":"Prospective Monitoring of Angiotensin Receptor Neprilysin Inhibitor in Older Adults With Heart Failure and Frailty","status":"UNKNOWN","sponsor":"Brigham and Women's Hospital","startDate":"2021-01-14","conditions":"Heart Failure, Systolic, Frailty","enrollment":40000},{"nctId":"NCT02609490","phase":"PHASE3","title":"Azilsartan in Chinese Patients With Mild and Moderate Hypertension","status":"COMPLETED","sponsor":"Lee's Pharmaceutical Limited","startDate":"2015-09","conditions":"Hypertension","enrollment":304},{"nctId":"NCT01715584","phase":"PHASE4","title":"Is There an Adverse Drug Reaction Between Renin-Angiotensin System Blockade and Inhaled Anesthetics","status":"UNKNOWN","sponsor":"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","startDate":"2012-07","conditions":"Hypertension","enrollment":80},{"nctId":"NCT02407210","phase":"PHASE3","title":"Efficacy and Safety of Azilsartan Compared to Olmesartan Medoxomil in Chinese Participants With Grade I or II Essential Hypertension","status":"UNKNOWN","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2015-01","conditions":"Essential Hypertension","enrollment":304},{"nctId":"NCT01309828","phase":"PHASE3","title":"Long-Term Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Hypertension and Kidney Disease","status":"COMPLETED","sponsor":"Takeda","startDate":"2011-03","conditions":"Safety","enrollment":153},{"nctId":"NCT00996281","phase":"PHASE3","title":"Safety and Tolerability of Azilsartan Medoxomil Plus Chlorthalidone Compared to Olmesartan Medoxomil Plus Hydrochlorothiazide in Participants With Essential Hypertension","status":"COMPLETED","sponsor":"Takeda","startDate":"2009-10","conditions":"Essential Hypertension","enrollment":837},{"nctId":"NCT00846365","phase":"PHASE3","title":"Efficacy and Safety of Azilsartan Medoxomil Plus Chlorthalidone in Participants With Moderate to Severe Hypertension","status":"COMPLETED","sponsor":"Takeda","startDate":"2009-03","conditions":"Essential Hypertension","enrollment":1085},{"nctId":"NCT01033071","phase":"PHASE3","title":"Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Moderate to Severe Hypertension.","status":"COMPLETED","sponsor":"Takeda","startDate":"2010-01","conditions":"Essential Hypertension","enrollment":1071},{"nctId":"NCT00696241","phase":"PHASE3","title":"Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension","status":"COMPLETED","sponsor":"Takeda","startDate":"2007-06","conditions":"Hypertension","enrollment":1275},{"nctId":"NCT00696436","phase":"PHASE3","title":"An Efficacy and Safety Study of Azilsartan Medoxomil Compared to Valsartan and Olmesartan in Participants With Essential Hypertension.","status":"COMPLETED","sponsor":"Takeda","startDate":"2008-04","conditions":"Hypertension","enrollment":1291},{"nctId":"NCT00362115","phase":"PHASE2","title":"Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension","status":"COMPLETED","sponsor":"Takeda","startDate":"2006-05","conditions":"Hypertension","enrollment":449},{"nctId":"NCT00759551","phase":"PHASE2","title":"Efficacy and Safety of Azilsartan in Subjects With Essential Hypertension","status":"COMPLETED","sponsor":"Takeda","startDate":"2004-08","conditions":"Hypertension","enrollment":555}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":29,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["TAK-491","Edarbi"],"phase":"phase_3","status":"active","brandName":"Azilsartan medoxomil and olmesartan","genericName":"Azilsartan medoxomil and olmesartan","companyName":"Takeda","companyId":"takeda","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination of two angiotensin II receptor blockers (ARBs) blocks the angiotensin II type 1 receptor to reduce blood pressure and provide cardiovascular protection. Used for Hypertension (investigational combination therapy).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}