Drugs / Azilsartan
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03434977 | Feb → Mar 2018 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT03042299 | Feb → Mar 2017 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02786082 | Nov 2016 → Aug 2017 | hypertensive disorder | Lee's Pharmaceutical Limited | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT01289132 | Jul 2007 → Jul 2008 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00759551 | Aug 2004 → Jun 2005 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00762736 | Jul 2004 → Oct 2005 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 39 trials · 1 missed | ||||||
| Phase 3 | NCT04668157 | May 2021 → Dec 2023 | hypertensive disorder | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT04606563 | Oct 2020 → Apr 2022 | COVID-19 | University of British Columbia | Terminated | Missed primary |
| Phase 3 | NCT02791438 | Aug 2016 → Jun 2019 | early onset hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02609490 | Sep 2015 → Feb 2017 | essential hypertension | Lee's Pharmaceutical Limited | Completed | No outcome recorded |
| Phase 3 | NCT02451150 | Aug → Sep 2015 | early onset hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02407210 | Jan → Oct 2015 | essential hypertension | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT02277691 | Nov 2014 → Apr 2016 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01124656 | Sep 2006 → May 2007 | type 2 diabetes mellitus | Takeda | Terminated | No outcome recorded |
| Phase 3 | NCT00376181 | Jun 2006 → May 2007 | type 2 diabetes mellitus | Takeda | Terminated | No outcome recorded |
| Phase 43 trials · 1 missed | ||||||
| Phase 4 | NCT05841654 | Jun 2023 → Jun 2025 | atrial fibrillation, hypertensive disorder | Beijing Tsinghua Chang Gung Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02400775 | Mar 2015 → Apr 2016 | — | Takeda | Withdrawn | No outcome recorded |
| Phase 4 | NCT02079805 | Jun 2014 → Apr 2016 | type 2 diabetes mellitus | Takeda | Completed | Missed primary |
| Phase not applicable2 trials · 1 missed | ||||||
| — | NCT05753696 | Apr 2023 → Oct 2024 | diabetic kidney disease, hypertensive disorder, impaired renal function disease, proteinuria | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| — | NCT01762501 | Dec 2012 → Dec 2013 | essential hypertension | Sogo Rinsho Médéfi Co., Ltd. | Completed | Missed primary |
| Comparator or background therapy3 trials | ||||||
| Phase 2/3 | NCT02235519 Comparator | Jan 2014 → Jun 2015 | hypertensive disorder, obesity disorder, type 2 diabetes mellitus | Hospital General de México Dr. Eduardo Liceaga | Unknown | No outcome recorded |
| Phase 4 | NCT01609959 Comparator | Jun 2012 → Sep 2013 | hypertensive disorder | Nara Medical University | Completed | No outcome recorded |
| — | NCT07683585 Comparator | Apr → Jul 2026 overdue | coronary artery disorder, hypertensive disorder | National Medical Research Center for Therapy and Preventive Medicine | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2022-09-30 | Lee's Pharmaceutical Limited | Regulatory Azilsartan tablets obtained Drug Marketing Authorization leespharm.com ↗
The drug has been approved to treat hypertension. |
| 2014-03-24 | Takeda | Regulatory Takeda Announces the New Drug Application Approval of Zacras ® Combination Tablets LD and Zacras ® Combination Tablets HD in Japan for the Treatment of Hypertension takeda.com ↗
Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application (NDA) of Zacras ® tablets, a fixed-dose combination ("FDC") of azilsartan* (generic name) and amlodipine besylate hydrochloride (generic name, "amlodipine"), for treatment of hypertension. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-04-02 | Lee's Pharmaceutical Limited | Azilsartan Tablets won the “Guangdong Prominent High-tech Products” award leespharm.com ↗ |
| 2022-09-30 | Lee's Pharmaceutical Limited | Azilsartan tablets obtained Drug Marketing Authorization leespharm.com ↗ |
| 2014-06-18 | Takeda | Zacras ® Combination Tablets LD and Zacras ® Combination Tablets HD, Fixed-Dose Combination of Azilsartan and Amlodipine, and Azilva ® Tablets 10mg, Treatment for Hypertension, are Now Available in Japan takeda.com ↗ |
| 2014-03-24 | Takeda | Takeda Announces the New Drug Application Approval of Zacras ® Combination Tablets LD and Zacras ® Combination Tablets HD in Japan for the Treatment of Hypertension takeda.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Azilsartan | “This study aimed to evaluate the long-term safety and efficacy of a triple combination therapy with 20 mg azilsartan (AZL), 5 mg amlodipine (AML) and 12.5 mg hydrochlorothiazide (HCTZ).” PMID 29235365 ↗ Dec 201720“A Phase 1 Food Effect Study of Azilsartan (TAK-536) Pediatric Formulation” NCT03434977 ↗ |
| Known as | AZL | “This study aimed to evaluate the long-term safety and efficacy of a triple combination therapy with 20 mg azilsartan (AZL), 5 mg amlodipine (AML) and 12.5 mg hydrochlorothiazide (HCTZ).” PMID 29235365 ↗ Dec 2017 |
| Known as | TAK-536 | “AD-4833-536 is a combination of AD-4833 (pioglitazone) and TAK-536 (azilsartan).” NCT01124656 ↗ |
| Action | Inhibit | “TAK-536 (azilsartan) is a synthetic angiotensin II type-1 receptor antagonist” NCT00759551 ↗ |
| Route | Oral | “Pioglitazone 45 mg and Azilsartan 20 mg combination tablets, orally, once daily” NCT00376181 ↗ |