Drugs / Iodixanol
Iodixanol
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | VISIPAQUE 270 | — | 1997-10-10 – 2017-04-05 | fda.gov ↗ |
| Approved | US (FDA) | VISIPAQUE 270 | — | 1996-03-22 | fda.gov ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02377895 | Mar → Jul 2015 | seasonal allergic rhinitis | 3E Therapeutics Corporation | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00348608 | Jun → Dec 2006 | coronary artery disorder | GE Healthcare | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00335335 | May → Dec 2006 | coronary artery disorder | GE Healthcare | Terminated | No outcome recorded Stop: Business |
| Phase 412 trials · 1 met primary · 2 missed | ||||||
| Phase 4 | NCT03631771 | Mar 2022 → Aug 2024 | hypothyroidism | GE Healthcare | Withdrawn | No outcome recorded |
| Phase 4 | NCT03119662 | Feb → Sep 2018 | chronic kidney disease | GE Healthcare | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01848899 | Feb → Nov 2013 | coronary artery disorder | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT01580046 | Apr 2012 → Dec 2013 | chronic renal failure syndrome | Yong Huo | Unknown | No outcome recorded |
| Phase 4 | NCT01376089 | May → Oct 2011 | — | GE Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT01137786 | Dec 2010 → Apr 2012 | coronary stenosis | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00823628 | Feb 2009 → May 2010 | chronic kidney disease, coronary artery disorder | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00390585 | Jul 2006 → Jan 2008 | chronic kidney disease, coronary atherosclerosis | German Heart Center Munich | Completed | Missed primary |
| Phase 4 | NCT00335101 | Jun 2006 → ? | coronary artery disorder, diabetes mellitus, impaired renal function disease | GE Healthcare | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT00209430 | Aug 2005 → ? | coronary artery disorder, impaired renal function disease | GE Healthcare | Completed | Missed primary |
| Phase 4 | NCT00209404 | Jul 2005 → ? | coronary artery disorder | GE Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT00247325 | Jan → Dec 2004 | kidney failure | Seoul National University Hospital | Completed | Met primary |
| Phase not applicable3 trials | ||||||
| — | NCT01935141 | Jan 2016 → Dec 2017 | pulmonary embolism | VA Greater Los Angeles Healthcare System | Withdrawn | No outcome recorded |
| — | NCT01843426 | Feb 2013 → Sep 2017 | aortic valve stenosis | Medical University of South Carolina | Completed | No outcome recorded |
| — | NCT01188486 | Aug 2010 → Apr 2017 | mesothelioma, non-small cell lung carcinoma, small cell lung carcinoma | Stanford University | Terminated | No outcome recorded Stop: Business |
| Comparator or background therapy19 trials | ||||||
| Phase 0 | NCT01908309 Comparator | Apr 2013 → Oct 2014 | acute kidney injury | Azienda Sanitaria Locale 9, Grosseto | Completed | No outcome recorded |
| Phase 1/2 | NCT01004770 Comparator | Oct 2009 → Feb 2010 | — | GE Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT03333330 Background | Apr 2012 → Oct 2017 | atherosclerosis, ischemic stroke | Enrico Ammirati | Completed | No outcome recorded |
| Phase 4 | NCT05065073 Comparator | Sep 2021 → Mar 2023 | coronary artery disorder | Minneapolis Heart Institute Foundation | Unknown | No outcome recorded |
| Phase 4 | NCT01475097 Comparator | Oct 2011 → Feb 2013 | — | GE Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT01136876 Comparator | Nov 2010 → Nov 2012 | coronary stenosis | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT01136915 Comparator | Nov 2010 → Nov 2012 | coronary stenosis | Bracco Diagnostics, Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01075217 Comparator | Apr 2010 → Dec 2011 | peripheral arterial occlusive disease 1 | Bracco Diagnostics, Inc | Completed | Missed primary |
| Phase 4 | NCT00804531 Background | Apr 2009 → May 2015 | — | Assistance Publique - Hôpitaux de Paris | Completed | Met primary |
| Phase 4 | NCT00782639 Comparator | Mar → Sep 2009 | chronic kidney disease, diabetes mellitus | Bracco Diagnostics, Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00926562 Comparator | Feb 2009 → Dec 2010 | chronic renal failure syndrome | Chinese PLA General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00793182 Comparator | Jan → Jun 2009 | impaired renal function disease | Guerbet | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00827788 Comparator | Dec 2008 → Apr 2010 | acute myocardial infarction, acute tubulointerstitial nephritis | Ospedale San Donato | Completed | No outcome recorded |
| Phase 4 | NCT01402219 Comparator | Nov 2008 → Feb 2013 | chronic kidney disease | Guangdong Provincial People's Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT00740207 Comparator | Sep 2008 → Jul 2009 | peripheral arterial occlusive disease 1 | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00347022 Comparator | May 2006 → Apr 2009 | — | Guerbet | Completed | No outcome recorded |
| Phase 4 | NCT00209417 Comparator | Jun 2005 → May 2011 | diabetes mellitus, impaired renal function disease | GE Healthcare | Terminated | No outcome recorded |
| — | NCT02405377 Background | Feb 2014 → Feb 2015 | cardio-renal syndrome | Chinese PLA General Hospital | Completed | No outcome recorded |
| — | NCT01146639 Background | Aug 2008 → May 2010 | abdominal aortic aneurysm | Norwegian University of Science and Technology | Completed | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | iodixanol | “VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution” NCT00740207 ↗32“100 mL iodixanol (Visipaque Injection 320 mg I/mL), followed by a 10 mL saline flush to ensure delivery of the full dose of Visipaque.” NCT03119662 ↗ “Iodixanol, 320 mg of iodine per millilitre, Visipaque 320 (GE Healthcare, Milwaukee, WI, USA) for contrast-enahnced CTA” NCT03333330 ↗ “Iodixanol is a commonly used contrast media agent that shows efficacy on the signs and symptoms of AR.” PMID 30881050 ↗ Mar 2019 “IODIXANOL 320” NCT01137786 ↗ |
| Known as | iodixanol-320 | “The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320...” NCT00782639 ↗ |
| Known as | Nasapaque | “The objectives of this study were to evaluate the safety and efficacy of iodixanol nasal solution (Nasapaque) for AR treatment, using the Allergen BioCube® (ABC®), an...” PMID 30881050 ↗ Mar 2019 |
| Known as | Visipaque | “The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol).” NCT00209404 ↗6“RECOVER:Comparison of Renal Toxicity Between Visipaque(Iodixanol)and Hexabrix(Ioxaglate)in Renal Insufficiency Undergoing Coronary Angiography” NCT00247325 ↗ “100 mL iodixanol (Visipaque Injection 320 mg I/mL), followed by a 10 mL saline flush to ensure delivery of the full dose of Visipaque.” NCT03119662 ↗ |
| Known as | Visipaque 270 | “Low-volume, low-concentration contrast (iodixanol - Visipaque 270) CT scan” NCT01843426 ↗ |
| Known as | Visipaque 320 | “The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320...” NCT00782639 ↗1“Iodixanol, 320 mg of iodine per millilitre, Visipaque 320 (GE Healthcare, Milwaukee, WI, USA) for contrast-enahnced CTA” NCT03333330 ↗ |
| Modality | Diagnostic / imaging agent | “contrast medium called Visipaque™ (iodixanol)” NCT00209404 ↗ |
| Route | Intravenous | “intravenous use of X-ray contrast media” NCT00209417 ↗ |