{"id":"olmetec","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":["Acute pancreatitis","Angioedema","Anuria","Azotemia","Chronic idiopathic constipation","Dehydration","Diabetes mellitus","Diabetes mellitus type 2","Gout","Hepatic coma","Hepatic failure","Hypercalcemia","Hypercholesterolemia","Hyperkalemia","Hyperparathyroidism","Hyperuricemia","Hypochloremic alkalosis","Hypokalemia","Hypomagnesemia","Hyponatremia","Hypovolemia","Kidney disease","Low blood pressure","Neonatal hyperbilirubinemia","Pregnancy, function","Renal artery stenosis","Secondary angle-closure glaucoma","Severe Aortic Valve Stenosis","Sympathectomy","Systemic lupus erythematosus"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"trials":[],"_chembl":{"chemblId":"CHEMBL1200692","moleculeType":"Small molecule","molecularWeight":"558.60"},"aliases":["the reference product"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"_dailymed":null,"ecosystem":[],"mechanism":{"target":"Type-1 angiotensin II receptor, Type-1 angiotensin II receptor"},"_scrapedAt":"2026-03-28T04:18:07.854Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"references":[],"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Hypertensive disorder","diseaseId":"hypertensive-disorder","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05017987","phase":"PHASE1","title":"Clinical Trial to Compare Pharmacokinetics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012","status":"COMPLETED","sponsor":"Autotelicbio","startDate":"2021-06-19","conditions":"Healthy Adult Volunteers","enrollment":36},{"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":"NCT03009487","phase":"PHASE3","title":"A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2017-01","conditions":"Hypertension, Hyperlipidemias","enrollment":265},{"nctId":"NCT04856969","phase":"PHASE1","title":"Clinical Trial to Evaluate Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers","status":"COMPLETED","sponsor":"Autotelicbio","startDate":"2021-03-30","conditions":"Healthy Adult Volunteers","enrollment":38},{"nctId":"NCT04138888","phase":"PHASE1","title":"A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions","status":"UNKNOWN","sponsor":"Pharmtechnology LLC","startDate":"2019-10-31","conditions":"Bioequivalence","enrollment":32},{"nctId":"NCT04161001","phase":"PHASE3","title":"Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451","status":"UNKNOWN","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2019-11-20","conditions":"Hypertension, Dyslipidemia","enrollment":237},{"nctId":"NCT03951051","phase":"PHASE1","title":"The Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil After a Single Oral Dose Administration Under Fasting Conditions.","status":"COMPLETED","sponsor":"Pharmtechnology LLC","startDate":"2019-05-06","conditions":"Bioequivalence","enrollment":32},{"nctId":"NCT01838850","phase":"PHASE3","title":"Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Combination Therapy in Patients With Hypertension Not Controlled With Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy","status":"COMPLETED","sponsor":"Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company","startDate":"2013-04","conditions":"Essential Hypertension","enrollment":344},{"nctId":"NCT02495324","phase":"PHASE4","title":"Fimasartan Achieving SBP Target (FAST) Study","status":"COMPLETED","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2015-06","conditions":"Essential,Hypertension","enrollment":369},{"nctId":"NCT01611077","phase":"PHASE4","title":"Efficacy and Safety of a Therapy Change From Candesartan 32 mg to Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg","status":"COMPLETED","sponsor":"Institut für Pharmakologie und Präventive Medizin","startDate":"2012-01","conditions":"Hypertension","enrollment":88},{"nctId":"NCT02561884","phase":"PHASE1","title":"A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study on a Olostar Tab Versus Two Co-administered Reference Products Olmesartan Medoxomil and Rosuvastatin Calcium in Healthy Volunteers","status":"UNKNOWN","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2015-10","conditions":"Healthy","enrollment":58},{"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":"NCT01493856","phase":"PHASE1","title":"A Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2012-01","conditions":"Healthy Volunteers","enrollment":58},{"nctId":"NCT01415466","phase":"PHASE1","title":"Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and CS-866 in Healthy Male Volunteers","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2011-08","conditions":"Healthy","enrollment":36},{"nctId":"NCT01180205","phase":"PHASE4","title":"Telmisartan, Amlodipine and Flow Mediated Dilation","status":"UNKNOWN","sponsor":"Johannes Gutenberg University Mainz","startDate":"2010-08","conditions":"Hypertension","enrollment":576},{"nctId":"NCT00949884","phase":"PHASE4","title":"Olmesartan Comparison to Losartan in Hypertensive Subjects","status":"COMPLETED","sponsor":"Daiichi Sankyo","startDate":"2009-08","conditions":"Hypertension","enrollment":941},{"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},{"nctId":"NCT00811226","phase":"","title":"Assessment of the Effectiveness of OLMETEC® and OLMETEC PLUS® for Treatment of Hypertension in Stage I and II Patients (Study P05254)(COMPLETED)","status":"COMPLETED","sponsor":"Schering-Plough","startDate":"2007-04","conditions":"Hypertension","enrollment":450}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":9,"therapeuticAreas":["Cardiovascular"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"phase_1","status":"active","brandName":"Olmetec","genericName":"Olmetec","companyName":"Daewoong Pharmaceutical Co. LTD.","companyId":"daewoong-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}