Drugs / Olmesartan
Olmesartan
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT02665832 | Jan → Jun 2016 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT02089399 | May → Jun 2014 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT02955498 | Apr → May 2014 | — | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01823900 | Jan → Feb 2012 | — | Severance Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01831479 | Aug → Sep 2011 | — | Severance Hospital | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary | ||||||
| Phase 2 | NCT07810088 | Jun 2025 → Jun 2028 expected | hormone receptor-positive breast cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2 | NCT03655964 | Aug 2018 → Aug 2019 | ischemic stroke | Aristotle University Of Thessaloniki | Completed | No outcome recorded |
| Phase 2 | NCT03024476 | Sep 2016 → Dec 2017 | hypertensive disorder, ischemic stroke | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02516826 | Aug 2015 → Aug 2018 | coronary artery disorder | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT01692301 | Dec 2012 → Apr 2015 | hypertensive disorder | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 38 trials · 2 met primary · 2 missed | ||||||
| Phase 3 | NCT05110898 | Aug 2022 → Aug 2023 | essential hypertension | Brainfarma | Unknown | No outcome recorded |
| Phase 3 | NCT04606563 | Oct 2020 → Apr 2022 | COVID-19 | University of British Columbia | Terminated | Missed primary |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | Mixed |
| Phase 3 | NCT01785472 | Apr 2013 → Aug 2014 | essential hypertension | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01613209 | Dec 2011 → Sep 2012 | hypertensive disorder | Institute for Pharmacology and Preventive Medicine | Completed | No outcome recorded |
| Phase 3 | NCT00696241 | Jun 2007 → Oct 2008 | essential hypertension | Takeda | Completed | Met primary |
| Phase 3 | NCT00098137 | Jan 2005 → May 2009 | paroxysmal atrial fibrillation | Atrial Fibrillation Network | Completed | Missed primary |
| Phase 3 | NCT02493322 | ? → Jun 2025 | essential hypertension | EMS | Withdrawn | No outcome recorded |
| Phase 46 trials · 1 met primary | ||||||
| Phase 4 | NCT05917275 | Apr 2024 → Oct 2025 | essential hypertension | Radboud University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT06275763 | Oct 2023 → Dec 2025 | hypertensive disorder | National Institute of Cardiology, Warsaw, Poland | Unknown | No outcome recorded |
| Phase 4 | NCT05189015 | Jan 2021 → Jun 2022 | hypertensive disorder, type 2 diabetes mellitus | Seoul National University Bundang Hospital | Completed | Met primary |
| Phase 4 | NCT02373462 | Aug → Nov 2015 | peripheral arterial disease | Yonsei University | Terminated | No outcome recorded |
| Phase 4 | NCT01713920 | Apr 2010 → Sep 2014 | hypertensive disorder | Sang Hyun Ihm, MD PhD | Completed | No outcome recorded |
| Phase 4 | NCT01089452 | — | hypertensive disorder | Monash University | Withdrawn | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00834600 | Dec 2005 → Oct 2011 | hypertensive disorder | The Louis & Rachel Rudin Foundation | Completed | No outcome recorded |
| Comparator or background therapy27 trials | ||||||
| Phase 1 | NCT04856969 Comparator | Mar → May 2021 | — | Autotelicbio | Completed | No outcome recorded |
| Phase 2 | NCT05103332 Background | Nov 2021 → Dec 2023 | essential hypertension | Alnylam Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01870739 Comparator | Oct 2013 → Jun 2015 | hypertensive disorder | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT00362115 Comparator | May → Dec 2006 | hypertensive disorder | Takeda | Completed | Met primary |
| Phase 2 | NCT00759551 Comparator | Aug 2004 → Jun 2005 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT04161001 Comparator | Nov 2019 → Nov 2021 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 3 | NCT03009487 Comparator | Jan 2017 → Apr 2018 | hyperlipidemia, hypertensive disorder | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 3 | NCT01876368 Comparator | Sep 2013 → Aug 2014 | essential hypertension | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01764295 Comparator | Sep 2012 → May 2013 | hyperlipidemia, hypertensive disorder | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 3 | NCT01615198 Comparator | Aug 2012 → Jul 2013 | essential hypertension | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01599104 Comparator | Jun 2012 → Apr 2013 | essential hypertension | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00696436 Comparator | Apr 2008 → Aug 2009 | essential hypertension | Takeda | Completed | Met primary |
| Phase 3 | NCT02483936 Comparator | ? → Jun 2025 | essential hypertension | EMS | Withdrawn | No outcome recorded |
| Phase 4 | NCT04394117 Comparator | Jun 2020 → Nov 2021 | COVID-19 | The George Institute | Completed | No outcome recorded |
| Phase 4 | NCT04330300 Comparator | Apr 2020 → Jul 2021 | COVID-19, essential hypertension | National University of Ireland, Galway, Ireland | Suspended | No outcome recorded Stop: Business |
| Phase 4 | NCT04120753 Comparator | Aug 2019 → Jul 2021 | hyperlipidemia, hypertensive disorder | Daewoong Pharmaceutical Co. LTD. | Completed | Met primary |
| Phase 4 | NCT04061824 Comparator | May 2016 → Dec 2018 | hyperlipidemia, hypertensive disorder | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT02996916 Comparator | Dec 2015 → Dec 2018 | — | Kurume University | Unknown | No outcome recorded |
| Phase 4 | NCT01377285 Background | Jun 2010 → Dec 2018 | chronic renal failure syndrome | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01271374 Comparator | Apr 2010 → Jun 2011 | hypertensive disorder | InVasc Therapeutics, Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT01101009 Comparator | Apr 2010 → Nov 2012 | hypertensive disorder | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Completed | No outcome recorded |
| Phase 4 | NCT00741585 Comparator | Sep 2008 → Jun 2018 | chronic kidney disease, essential hypertension, stroke disorder | University of Vigo | Completed | No outcome recorded |
| Phase 4 | NCT00295542 Comparator | Mar 2000 → Apr 2009 | hypertensive disorder | University of Vigo | Completed | No outcome recorded |
| — | NCT03560804 Comparator | Nov 2014 → Sep 2017 | arteriosclerosis disorder | AHEPA University Hospital | Completed | No outcome recorded |
| — | NCT01028534 Comparator | Jul 2010 → Dec 2013 | hypertensive disorder, obstructive sleep apnea syndrome | Kyoto University, Graduate School of Medicine | Completed | No outcome recorded |
| — | NCT00122447 Comparator | May 2005 → May 2011 | glucose intolerance, prediabetes syndrome | Emory University | Completed | No outcome recorded |
| — | NCT00684489 Comparator | Sep 2003 → Mar 2005 | essential hypertension | Medical University of South Carolina | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2021-02-18 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical’s Olostar confirmed better effect than co-administration of individual drugs daewoong.co.kr ↗
The results showed that the Olostar group showed a higher level of adherence and improved both systolic and diastolic blood pressure. |
| 2020-11-30 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical’s Olostar proved its excellent blood pressure reduction effects… Published in an SCI-grade journal daewoong.co.kr ↗
The results of the research indicated a meaningful decrease in both systolic and diastolic blood pressure on group with Olostar relative to the other group that was administered a combination of other ARBs and atorvastatin. |
| 2019-03-04 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical has completed the lineup of hypertension medications with the approval of ‘Olomax.’ daewoong.co.kr ↗
Daewoong Pharmaceutical (CEO Sengho Jeon) announced last 27th that KFDA has approved ‘Olomax,’ the compound of Amlodipine added to ‘Olostar,’ the existing compound of Olmesartan and Rosuvastatin. |
| 2017-04-28 | Lupin Limited | Regulatory Lupin receives FDA approval for generic Benicar® Tablets lupin.com ↗ |
| 2017-02-15 | Daiichi Sankyo | Regulatory Daiichi Sankyo Strengthens Authorized Generic Business through Daiichi Sankyo Espha daiichisankyo.com ↗
Today, Daiichi Sankyo Espha obtained approval for manufacturing and marketing for multiple AG products, including the following products: |
| 2016-12-25 | Lupin Limited | Regulatory Lupin Receives Tentative Approval for Generic Benicar® Tablets lupin.com ↗ |
| 2016-03-17 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceuticals - Daiichi-Sankyo Korea Expect sales of 30 billion won this year with Sevikar HCT daewoong.co.kr ↗
Whereas a double combination drug of Amlodipine and Olmesartan Medoxomil were not effective, Sevikar HCT displayed significant reduction in both systolic and diastolic pressure. |
| 2014-02-10 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical received domestic approval for its OLOSTAR, the new complex combining the Olmesatan and rosuvastatin for the first time worldwide daewoong.co.kr ↗
Daewoong Pharmaceutical Co.,Ltd(President: Lee Jong-wook) received the approval from the Ministry of Food and Drug Safety(MFDS) for its OLOSTAR, a new anti-hypertensive drug which was developed with its proprietary technology. |
| 2011-07-04 | Daewoong Pharmaceutical Co. LTD. | Results Sevikar, antihypertensive agent, proved 24 hours long effect daewoong.co.kr ↗
As a result, it was found that Sevikar reached target BP for 24 hours (70.9%), and had an excellent BP reduction in systolic pressure compared with placebo at 21.4mmHg. |
| 2010-12-21 | Daiichi Sankyo | Regulatory Daiichi Sankyo Announces First European Approval for Sevikar HCT(R), a New Three-in-one Combination Product for the Treatment of High Blood Pressure* daiichisankyo.com ↗
Daiichi Sankyo Europe announced today that Sevikar HCT® is now approved in Germany, the first market to launch this new once-daily three-in-one combination product for the treatment of high blood pressure (BP). |
| 2010-07-27 | Daiichi Sankyo | Regulatory FDA APPROVES TRIBENZOR™, A NEW THREE-IN-ONE COMBINATION PRODUCT FOR THE TREATMENT OF HIGH BLOOD PRESSURE daiichisankyo.com ↗
FDA APPROVES TRIBENZOR™, A NEW THREE-IN-ONE COMBINATION PRODUCT FOR THE TREATMENT OF HIGH BLOOD PRESSURE |
| 2010-02-15 | Daiichi Sankyo | Regulatory FDA Approves Benicar(R) for the Treatment of High Blood Pressure in Children and Adolescents aged 6-16(1) daiichisankyo.com ↗
Daiichi Sankyo, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the hypertension treatment Benicar® (olmesartan medoxomil) for use in children and adolescents 6 to 16 years of age. |
| 2010-01-20 | Daiichi Sankyo | Regulatory Daiichi Sankyo Receives Approval to Manufacture and Market Rezaltas(R) Combination Tablets to Treat Hypertension daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter; Daiichi Sankyo) today announced that it has received approval in Japan to manufacture and market Rezaltas® combination tablets LD and HD for the treatment of hypertension. |
| 2008-11-13 | Daiichi Sankyo | Regulatory DAIICHI SANKYO EUROPE GmbH announce SEVIKAR® a new fixed dose combination treatment for essential hypertension daiichisankyo.com ↗
GERMANY, the European headquarter of DAIICHI SANKYO, is the latest country in Europe to grant marketing approval for SEVIKAR® |
| 2008-06-18 | Daiichi Sankyo | Results New Study Shows Benicar(R) (olmesartan medoxomil) Reverses Blood Vessel Damage Independent of Blood Pressure Lowering daiichisankyo.com ↗
In the VIOS trial, olmesartan medoxomil, through early blockade of angiotensin II, improved the structure abnormalities of resistance arteries in patients with hypertension as measured by arterial wall to lumen ratio (W/L), returning arterial architecture to normal levels after one year of treatment. |
| 2007-10-01 | Daiichi Sankyo | Regulatory DAIICHI SANKYO EUROPE is applying for approval of its new combination product of Olmesartan and Amlodipin daiichisankyo.com ↗
DAIICHI SANKYO EUROPE GmbH has applied in 28 European countries for approval of a new antihypertensive medication. |
| 2007-09-28 | Daiichi Sankyo | Regulatory AZOR(TM) Receives FDA Approval for Treatment of High Blood Pressure daiichisankyo.com ↗
Daiichi Sankyo, Inc. announced today that the United States Food and Drug Administration (FDA) has approved AZOR(TM) (amlodipine and olmesartan medoxomil) for the treatment of hypertension, also known as high blood pressure. |
| 2007-05-22 | Daiichi Sankyo | Results Amlodipine and Olmesartan Study Results Released; Late Breaker Presented at American Society of Hypertension Twenty-Second Annual Scientific Meeting (ASH 2007) First Release of Data for New Combination daiichisankyo.com ↗
Combining the calcium channel blocker amlodipine besylate with the angiotensin receptor blocker olmesartan medoxomil, produced significant mean reductions in seated systolic and diastolic blood pressure in patients with hypertension, according to data presented at the American Society of Hypertension¨s Twenty-Second Annual Scientific Meeting at Exposition (ASH 2007). |
| 2005-10-07 | Daiichi Sankyo | Regulatory European Mutual Certification Completed for Antihypertensive daiichisankyo.com ↗
has successfully cleared the screening by relevant European member countries and is scheduled to obtain marketing authorization for the European market |
All press releases naming this drug 34 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | olmesartan | “The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a...” NCT02955498 ↗52“Replacement of ineffective antihypertensive treatment based on 3 or more antihypertensive drugs (single or dual drug preparations) with a triple single pill combination (SPC)...” NCT06275763 ↗ “The aim of this study was to evaluate the efficacy of olmesartan/amlodipine (OLM/AML) single-pill combination (SPC) therapy using ambulatory blood pressure monitoring (ABPM) in...” PMID 39504016 ↗ Nov 2024 “One of ARBs(Valsartan, Olmesartan, Candesartan, Telmisartan, Fimasartan, Losartan and Irbesartan) and one of statins(Rosuvastatin, Atorvastatin, Pitavastatin, Simvastatin,...” NCT04061824 ↗ “Treatment effect of olmesartan to hypertension and rosuvastatin to dyslipidemia is already proven in previous studies, and these medication does not have interaction with each other.” NCT04061824 ↗ “Angiotensin II receptor antagonists ,these medicines have names that end in "sartan".For examples:losartan,candesartan,irbesartan,olmesartan,telmisartan,valsartan” NCT01377285 ↗ “Single administration of a combination tablet of Rosuvastatin 20mg and Olmesartan 40mg” NCT01823900 ↗ “Candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan” NCT04330300 ↗ “eprosartan, irbesartan, losartan, olmesartan, telmisartan” NCT00684489 ↗ “Olmesartan:20mg，po，qd，q4w” NCT07810088 ↗ “Olmesartan” NCT00741585 ↗ |
| Known as | Benicar | “Initially, the participant will be treated with Benicar® (olmesartan) 20mg and Natrilix® (indapamide) 1,5 mg.” NCT05110898 ↗ |
| Known as | OLM | “renin-angiotensin system blockade with the angiotensin II receptor blocker olmesartan (OLM) plus AML” PMID 24293132 ↗ Nov 2013 |
| Known as | Olme | “triple-combination of olmesartan/amlodipine/rosuvastatin (Olme/Amlo/Rosu)” PMID 37814541 ↗ Jan 2023 |
| Known as | olmesartan medoxomil | “To compare this ARB with others in the class, we studied the effects of 2 doses of azilsartan medoxomil, with valsartan 320 mg and olmesartan medoxomil (olmesartan) 40 mg, in a...” PMID 21282560 ↗ Jan 2011 |
| Known as | Olmetec | “co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Rosuzet Tab. 10/20mg(Ezetimibe/Rosuvastatin 10/20mg) and placebo of Sevikar tab. 10/40mg (Amlodipine/Olmesartan 10/40mg)” NCT04161001 ↗1“co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg).” NCT03009487 ↗ |
| Action | Inhibit | “Blocking the angiotensin (AT) II type 1 receptor (Olmesartan) reduces the incidence of episodes of atrial fibrillation” NCT00098137 ↗ |
| Modality | Other / unclassified | “the ARB olmesartan medoxomil (OLM-M)” PMID 21272195 ↗ Feb 2011 |
| Route | Oral | “Olmesartan tablet, 1 in the morning” NCT00098137 ↗ |