Drugs / trandolapril
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | MAVIK | — | 1997-07-02 | fda.gov ↗ |
| Approved | US (FDA) | MAVIK | — | 1996-04-26 | fda.gov ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT00840632 | Oct → Nov 2004 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00840073 | Oct → Nov 2004 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | Mixed |
| Phase 45 trials · 2 met primary | ||||||
| Phase 4 | NCT02817360 | Feb 2016 → Dec 2025 overdue | heart disorder, type 2 diabetes mellitus | Martin Huelsmann | Recruiting | No outcome recorded |
| Phase 4 | NCT01669434 | Jun 2015 → Nov 2016 | — | University of Nebraska | Completed | Met primary |
| Phase 4 | NCT00235001 | Jun 2004 → Nov 2006 | hypertensive disorder | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT00233532 | Mar 2004 → Jun 2005 | hypertensive disorder | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT00133692 | Sep 1997 → Feb 2003 | coronary artery disorder, hypertensive disorder | University of Florida | Completed | Met primary |
| Phase not applicable2 trials · 1 missed | ||||||
| — | NCT01867047 | Jun 2013 → Jun 2016 | hypotensive disorder | Duke University | Terminated | Missed primary |
| — | NCT00212901 | Aug 2004 → Sep 2006 | diabetic kidney disease | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Comparator or background therapy12 trials | ||||||
| Phase 3 | NCT01437371 Background | Aug 2011 → Jun 2014 | heart failure | University Hospital, Clermont-Ferrand | Completed | No outcome recorded |
| Phase 3 | NCT00679653 Comparator | Feb 2002 → Dec 2003 | hypertensive disorder, obesity disorder | Abbott | 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 | NCT07513883 Background | Mar 2026 → Sep 2028 expected | heart failure | Ziekenhuis Oost-Limburg | Recruiting | 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 | NCT00887510 Comparator | May 2007 → Nov 2009 | hypertensive disorder | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT00391846 Background | Oct 2006 → Jan 2009 | left ventricular failure | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00252317 Comparator | Nov 2005 → Oct 2008 | aortic valve stenosis | Rigshospitalet, Denmark | Unknown | No outcome recorded |
| Phase 4 | NCT00234858 Comparator | Mar 2004 → Apr 2006 | hypertensive disorder, metabolic syndrome X | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT00234871 Comparator | Jan 2004 → Mar 2005 | diabetes mellitus, hypertensive disorder, proteinuria | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT00235014 Comparator | Mar 1997 → Jan 2006 | hypertensive disorder, type 2 diabetes mellitus | Abbott | Completed | No outcome recorded |
| — | NCT00684489 Comparator | Sep 2003 → Mar 2005 | essential hypertension | Medical University of South Carolina | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | trandolapril | “Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective...” NCT00212901 ↗20“Examples of possible ACE-I drugs include: benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril),...” NCT01867047 ↗ “Benazepril, captopril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril” NCT04330300 ↗ “ACE inhibitor: enalapril, lisinopril, ramipril, captopril or trandolapril” NCT07513883 ↗ “perindopril, quinapril, ramipril, trandolapril, candesartan” NCT00684489 ↗ “verapamil/trandolapril” NCT00679653 ↗ “Trandolapril 4mg/d” NCT02817360 ↗ “trandolapril” NCT01669434 ↗ “Trandolapril” NCT02735707 ↗ |
| Known as | Gopten | ChEMBL registry synonym — accepted as the source's own label CHEMBL1519 ↗ |
| Known as | Mavik | “Examples of possible ACE-I drugs include:
benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril),...” NCT01867047 ↗3“The objective of this study is to compare the rate and extent of absorption of trandolapril from a test formulation of Trandolapril 4 mg Tablets versus the reference Mavik® 4...” NCT00840632 ↗ “Mavik® 4 mg Tablets” NCT00840073 ↗ |
| Known as | NSC-758939 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1519 ↗ |
| Known as | Odrik | ChEMBL registry synonym — accepted as the source's own label CHEMBL1519 ↗ |
| Known as | RU 44570 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1519 ↗ |
| Known as | Trandolapril component of tarka | ChEMBL registry synonym — accepted as the source's own label CHEMBL1519 ↗ |
| Action | Inhibit | “the angiotensin-converting enzyme inhibitor trandolapril used as add-on therapy” PMID 17531579 ↗ Apr 2007 |
| Modality | Small molecule | — CHEMBL1519 ↗ |
| Target | ACE | “the angiotensin-converting enzyme inhibitor trandolapril used as add-on therapy” PMID 17531579 ↗ Apr 2007 |