Drugs / Candesartan cilexetil
Candesartan cilexetil
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | ATACAND | — | 2002-09-13 – 2009-10-22 | fda.gov ↗ |
| Approved | US (FDA) | ATACAND | — | 1998-06-04 | fda.gov ↗ |
Trials 41
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT04627207 | Nov 2020 → Mar 2021 | cardiovascular disorder | Chong Kun Dang Pharmaceutical | Unknown | No outcome recorded |
| Phase 1 | NCT02709187 | Mar → May 2016 | — | Alvogen Korea | Completed | No outcome recorded |
| Phase 1 | NCT02609711 | Nov 2015 → Mar 2016 | — | Ahn-Gook Pharmaceuticals Co.,Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT02548286 | Aug 2015 | hypertensive disorder | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT02707224 | Jan → Jun 2015 | — | Alvogen Korea | Completed | No outcome recorded |
| Phase 1 | NCT02254447 | Dec 2014 → Jan 2015 | cardiovascular disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02094924 | Apr → May 2014 | hypertensive disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02006602 | Dec 2013 → Jan 2014 | hypertensive disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02006589 | Dec 2013 → Jan 2014 | hypertensive disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01926652 | Jul → Aug 2013 | — | Shin Poong Pharmaceutical Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01845272 | Apr → Jul 2013 | — | HK inno.N Corporation | Unknown | No outcome recorded |
| Phase 1 | NCT03136666 | Apr → Jun 2010 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01025843 | Dec 2009 → May 2010 | hypertensive disorder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00905333 | Oct → Nov 2008 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT05122182 | Jan → Aug 2022 | COVID-19 | University of Sydney | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02944734 | Sep 2014 → Dec 2015 | essential hypertension | Shin Poong Pharmaceutical Co. Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02059616 | Feb 2014 → Jun 2015 | essential hypertension | HK inno.N Corporation | Unknown | No outcome recorded |
| Phase 2 | NCT01303783 | Apr 2011 → May 2012 | essential hypertension | Bayer | Completed | Met primary |
| Phase 2 | NCT00184587 | Mar 2005 → Jun 2009 | cluster headache syndrome | Norwegian University of Science and Technology | Completed | Missed primary |
| Phase 315 trials · 3 met primary | ||||||
| Phase 3 | NCT05920005 | Aug 2023 → Mar 2025 | hypertensive disorder | Hospital Israelita Albert Einstein | Completed | Met primary |
| Phase 3 | NCT02368665 | Dec 2014 → Nov 2015 | essential hypertension | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 3 | NCT02368652 | Dec 2014 → Nov 2015 | essential hypertension | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 3 | NCT01788358 | Feb 2013 → May 2014 | essential hypertension | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01613209 | Dec 2011 → Sep 2012 | hypertensive disorder | Institute for Pharmacology and Preventive Medicine | Completed | No outcome recorded |
| Phase 3 | NCT00679484 | Jun 2008 → Nov 2009 | symptomatic heart failure | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00690612 | Sep 2007 → Sep 2009 | hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00434967 | Jan 2007 → Jan 2008 | hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00383929 | Sep 2006 → Aug 2007 | hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00244621 | Nov 2004 → Aug 2008 | hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00244595 | Sep 2003 → Nov 2006 | hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00244634 | Sep 2003 → Nov 2005 | early onset hypertension | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00242346 | Apr 2003 → Dec 2006 | proteinuria | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00125463 | Sep 2001 → Dec 2005 | hypertensive disorder | The Japanese Society of Hypertension | Unknown | No outcome recorded |
| Phase 3 | NCT00227318 | Jul 1998 → Oct 2005 | hypertensive disorder | AstraZeneca | Completed | Met primary |
| Phase 47 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT01766505 | Jun 2012 → Mar 2014 | hypertensive disorder | Chong Kun Dang Pharmaceutical | Terminated | No outcome recorded |
| Phase 4 | NCT01611077 | Jan → Dec 2012 | essential hypertension | Institute for Pharmacology and Preventive Medicine | Completed | No outcome recorded |
| Phase 4 | NCT01012479 | Oct 2009 → May 2010 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT00621153 | Feb 2008 → Mar 2009 | hypertensive disorder | AstraZeneca | Completed | Met primary |
| Phase 4 | NCT00512759 | Dec 2007 → Aug 2018 | symptomatic heart failure | University Hospital, Basel, Switzerland | Completed | Missed primary |
| Phase 4 | NCT00573430 | Dec 2007 → Aug 2009 | hypertensive nephropathy | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00360763 | ? → Dec 2006 | hypertensive disorder | Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 2 | NCT05826912 Comparator | Aug 2024 → Aug 2028 expected | traumatic brain injury | University of California, San Francisco | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT04320589 Comparator | Jun 2019 → Aug 2021 | pheochromocytoma | National Cancer Institute, Egypt | Completed | No outcome recorded |
| Phase 2 | NCT02332824 Comparator | Oct 2014 → Aug 2016 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 2 | NCT01289132 Comparator | Jul 2007 → Jul 2008 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 2/3 | NCT01052272 Comparator | Jul 2005 → Nov 2010 | diabetes mellitus | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 3 | NCT02047019 Comparator | Dec 2017 → Dec 2019 | essential hypertension | Bayer | Withdrawn | No outcome recorded |
| Phase 3 | NCT01135212 Comparator | Apr 2010 → Apr 2011 | essential hypertension | Boryung Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT00081731 Comparator | Apr 2004 → Sep 2013 | atherosclerosis, renal artery obstruction, renovascular hypertension | Baim Institute for Clinical Research | Completed | No outcome recorded |
| Phase 4 | NCT07547878 Comparator | Apr 2026 → Mar 2029 expected | chronic kidney disease, type 2 diabetes mellitus | Baylor Research Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03847506 Comparator | Jul 2018 → Dec 2020 | hyperlipidemia | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 4 | NCT02774460 Comparator | Feb 2017 → Jun 2021 | hypertensive disorder | Uppsala University | Completed | No outcome recorded |
| Phase 4 | NCT01682564 Comparator | Jan 2012 → Oct 2014 | congestive heart failure, hypertensive disorder | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT01734096 Comparator | May 2009 → Apr 2013 | obesity disorder, resistant hypertension | PD Dr. Grégoire Wuerzner | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2019-08-28 | Upsher-Smith Laboratories | Regulatory MHLW Approves Additional Indications for CANDESARTAN Tablets and OD Tablets upsher-smith.com ↗
Osaka, Japan – August 28, 2019 – Sawai Pharmaceutical Co., Ltd. (Head office: Osaka, Japan, President: Mitsuo Sawai) today received approval of its partial change application by the Ministry of Health, Labour and Welfare (MHLW) for CANDESARTAN Tablets 2 mg, 4 mg, 8 mg and 12 mg [SAWAI], and CANDESARTAN OD Tablets 2 mg, 4 mg, 8 mg and 12 mg [SAWAI]*. |
| 2018-12-01 | Alembic Pharmaceuticals Ltd. | Regulatory 05th December, 2018, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Candesartan Cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg. |
| 2018-04-12 | Shin Poong Pharmaceutical Co. Ltd. | Results 칸데암로,에제로수 전국투어심포지움 shinpoong.co.kr ↗
칸데암로정은 우수한 목표혈압 달성률과 반응률을 나타냈고 , 단일제 대비 칸데암로정 고용량에서도 부작용이 경미해 , 고혈압치료에 있어서 주요제품으로 자리매김 할 것으로 기대했다 . |
All press releases naming this drug 9 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | candesartan cilexetil | “In this study, candesartan cilexetil, amlodipine, and atorvastatin was administered orally as FDCs of 16/10/40 mg in study 1 and 16/5/20 mg in study 2.” PMID 38771476 ↗ May 202446“Candemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks” NCT01766505 ↗ “fixed-dose combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg” NCT02548286 ↗ “Study 261A is a dose-ranging and safety study of candesartan cilexetil.” NCT00244634 ↗ “candesartan cilexetil antihypertensive effects” NCT00244595 ↗ |
| Known as | Atacand | “This study will investigate the relative bioavailability of two candidate tablet formulations of 16 milligram (mg) Candesartan cilexetil (GW615775) compared with the reference...” NCT02254447 ↗11“using sublingual nitrates (Nitroglycerin Streuli®) or nitrospray (Corangin Nitrospray®) transdermal nitrates (Nitroderm TTS 10®), ACE-inhibitors (Triatec®) and/or ARB (Atacand®).” NCT00512759 ↗ “will receive single oral doses of candesartan cilexetil (GW615775) and reference candesartan cilexetil (ATACAND™);” NCT02006589 ↗ “High Doses of Candesartan Cilexetil (Atacand®) on the Reduction of Proteinuria” NCT00242346 ↗ “Drug: Candesartan cilexetil (Atacand), 4 mg” NCT01303783 ↗ “reference candesartan cilexetil (ATACAND™)” NCT02006602 ↗ “Atacand 4-16 mg/day” NCT04320589 ↗ “Atacand” NCT00621153 ↗ |
| Known as | Atacand/HCT | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00081731 ↗ |
| Known as | Blopress | “The purpose of this study is to compare an angiotensin II receptor antagonist (candesartan cilexetil- Blopress®) and a calcium channel blocker (amlodipine besilate-...” NCT00125463 ↗ |
| Known as | CAN | “The purpose of this study was to explore the optimal dosage of a fixed-dose combination of candesartan cilexetil (CAN) and amlodipine besylate (AML), by examining the...” PMID 28734660 ↗ Jul 2017 |
| Known as | Candemore tablet | “Candemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks” NCT01766505 ↗ |
| Known as | candesartan | “Participants with repeated measurements of systolic pressure of 130 to 139 mm Hg and diastolic pressure of 89 mm Hg or lower, or systolic pressure of 139 mm Hg or lower and...” PMID 16537662 ↗ Mar 2006 |
| Known as | GW615775 | “This study will investigate the relative bioavailability of two candidate tablet formulations of 16 milligram (mg) Candesartan cilexetil (GW615775) compared with the reference...” NCT02254447 ↗2“This study aims to determine the relative bioavailability of an 8mg test formulation tablet of candesartan cilexetil (GW615775) compared to an 8mg reference tablet of...” NCT02006589 ↗ “candesartan cilexetil (GW615775, Test formulation)” NCT02006602 ↗ |
| Action | Inhibit | “an angiotensin II receptor antagonist (candesartan cilexetil- Blopress®)” NCT00125463 ↗ |
| Route | Oral | “0.05 mg/kg once daily oral liquid dose” NCT00244621 ↗ |