Drugs / Fluvastatin
Fluvastatin
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | LESCOL XL | — | 2003-05-27 – 2006-04-10 | fda.gov ↗ |
| Label expansions (5) | US (FDA) | LESCOL | — | 1996-03-20 – 2000-12-18 | fda.gov ↗ |
| Approved | US (FDA) | LESCOL | — | 1993-12-31 | fda.gov ↗ |
Trials 39 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04285749 | Nov 2020 → Apr 2021 | melanoma | Case Comprehensive Cancer Center | Withdrawn | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT00752843 | Sep → Nov 2008 | — | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06553157 | Sep 2024 → Jul 2025 | cancer, platinum-induced ototoxicity | Minia University | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT01992042 | Feb 2014 → Oct 2016 | prostate cancer | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2 | NCT00814606 | Feb → Oct 2010 | hepatitis C virus infection | University of Chicago | Withdrawn | No outcome recorded |
| Phase 2 | NCT00674297 | May 2008 → Jul 2011 | antiphospholipid syndrome | Hospital for Special Surgery, New York | Completed | No outcome recorded |
| Phase 2 | NCT00487318 | Jun 2007 → Oct 2010 | chronic hepatitis C virus infection | Bader, Ted, M.D. | Completed | No outcome recorded |
| Phase 2 | NCT00416403 | Jul 2006 → Sep 2007 | breast cancer | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2 | NCT00309257 | Jan 2004 → Jun 2008 | Alport syndrome | Mario Negri Institute for Pharmacological Research | Completed | No outcome recorded |
| Phase 2 | NCT00176410 | Jan 2003 → Sep 2009 | aortic valve stenosis | University of Leipzig | Unknown | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT00382161 | Oct 2006 → Dec 2007 | vasculogenic impotence | University Hospital, Saarland | Withdrawn | No outcome recorded |
| Phase 3 | NCT00136799 | Jun 2005 → Apr 2006 | hyperlipidemia, combined, 2, hyperlipoproteinemia | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00132717 | Jan 2005 → Jun 2007 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00171236 | Oct 2001 → Mar 2005 | familial hypercholesterolemia, hyperlipidemia, combined, 2 | Novartis | Completed | No outcome recorded |
| Phase 419 trials | ||||||
| Phase 4 | NCT06785727 | Feb 2025 → Dec 2028 expected | transient ischemic attack | Prof. dr. Nathalie van der Velde | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04029584 | Apr 2019 → Apr 2020 | — | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT03189511 | May 2017 → Jan 2018 | — | University of Zurich | Completed | No outcome recorded |
| Phase 4 | NCT01563731 | Apr 2013 → Dec 2020 | hypertensive disorder, transient ischemic attack | Istituto Auxologico Italiano | Completed | No outcome recorded |
| Phase 4 | NCT01681199 | Jul 2012 → Apr 2014 | atherosclerosis, coronary artery disorder | Beijing Anzhen Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01551173 | Jan 2012 → May 2013 | inherited lipid metabolism disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00489424 | Jun → Dec 2007 | osteoporosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00407680 | Oct 2006 → Mar 2009 | hypertensive disorder, type 2 diabetes mellitus | Kitasato University | Unknown | No outcome recorded |
| Phase 4 | NCT00664742 | Sep 2006 → Oct 2007 | metabolic syndrome X | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00385658 | Aug 2006 → Mar 2007 | hyperlipidemia | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00821574 | Jul 2005 → Mar 2007 | hyperlipidemia, combined, 2 | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00125125 | May → Dec 2005 | hyperlipidemia | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00223028 | Apr → Jul 2005 | — | University Hospital Schleswig-Holstein | Completed | No outcome recorded |
| Phase 4 | NCT00421005 | Nov 2004 → Nov 2008 | hyperlipidemia | University of Bologna | Unknown | No outcome recorded |
| Phase 4 | NCT00138528 | Oct 2004 → Feb 2006 | metabolic syndrome X | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00171262 | Aug 2004 → Jun 2007 | hyperlipidemia | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00171327 | Jul 2004 → Sep 2005 | hyperlipidemia, hypertensive disorder | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00223015 | May 2004 → Apr 2005 | — | University Hospital Schleswig-Holstein | Completed | No outcome recorded |
| Phase 4 | NCT00171275 | Nov 2003 → Feb 2007 | coronary artery disorder, myocardial infarction | Novartis | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT03393377 | Sep 2014 → Jun 2015 | atherosclerosis | University Medical Centre Ljubljana | Completed | No outcome recorded |
| — | NCT03309618 | Nov 2012 → Nov 2013 | myocardial infarction | University Medical Centre Ljubljana | Completed | No outcome recorded |
| — | NCT01634906 | Jul 2012 → Mar 2013 | atherosclerosis, hyperlipidemia | Sint Franciscus Gasthuis | Completed | No outcome recorded |
| — | NCT01514682 | Jun 2012 → Apr 2017 | schizophrenia | University of Maryland, Baltimore | Completed | No outcome recorded |
| — | NCT01259791 | Sep 2010 → Aug 2013 | statin toxicity | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| — | NCT00441493 | Sep 2006 → Mar 2007 | chronic hepatitis C virus infection | Bader, Ted, M.D. | Completed | No outcome recorded |
Also used as a comparator or background therapy in 17 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT01890967 Background | Jun 2013 → Apr 2014 | hyperlipoproteinemia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01045512 Comparator | Oct 2009 → Sep 2014 | — | Martin-Luther-University Halle-Wittenberg | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00223041 Comparator | Apr 2003 → Nov 2009 | — | University Hospital Schleswig-Holstein | Terminated | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT03510715 Background | Aug 2018 → Feb 2020 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT03510884 Background | May 2018 → Jan 2021 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02107898 Background | Mar 2014 → Jan 2015 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00532311 Comparator | Jul 2007 → Apr 2008 | hyperlipidemia | Takeda | Terminated | No outcome recorded |
| Phase 3 | NCT00127218 Background | Sep 2003 → Dec 2008 | atherosclerosis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 3 | NCT00171288 Background | Aug 2003 → Aug 2005 | hyperlipidemia | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00199927 Comparator | Mar 2003 → Dec 2007 | chronic kidney disease, hypertensive disorder, proteinuria | Mario Negri Institute for Pharmacological Research | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT04061824 Comparator | May 2016 → Dec 2018 | hyperlipidemia, hypertensive disorder | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT01715714 Comparator | Nov 2012 → Apr 2019 | coronary artery disorder | University of Cologne | Completed | No outcome recorded |
| Phase 4 | NCT01293097 Background | Jun 2010 → Oct 2011 | acute coronary syndrome, myocardial infarction | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00549926 Comparator | Oct 2007 → Feb 2010 | coronary artery disorder, hyperlipidemia | Yokohama City University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00404287 Comparator | Oct 2006 → Nov 2014 | aortic valve stenosis | AORTICA Group | Terminated | No outcome recorded |
| Phase 4 | NCT00814723 Comparator | Sep 2005 → Sep 2007 | hyperlipoproteinemia | Medical University of Graz | Completed | No outcome recorded |
| Phase 4 | NCT00565474 Comparator | Sep 2001 → Oct 2007 | disease related to transplantation | Novartis Pharmaceuticals | Completed | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 57 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fluvastatin | “One of ARBs(Valsartan, Olmesartan, Candesartan, Telmisartan, Fimasartan, Losartan and Irbesartan) and one of statins(Rosuvastatin, Atorvastatin, Pitavastatin, Simvastatin,...” NCT04061824 ↗53“3. Fluvastatin, 40 mgs/day. Fluvastatin is a lipid-lowering drugs, which acts through the inhibition of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-CoA).” NCT01514682 ↗ “Statin (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin) at stable dose with or without other LMT as clinically indicated.” NCT02107898 ↗ “can be any of the following statins: rosuvastatin, atorvastatin, simvastatin, fluvastatin, pravastatin in any of the doses causing symptoms previously” NCT01259791 ↗ “Statins include atorvastatin , fluvastatin , lovastatin , pitavastatin , pravastatin, rosuvastatin and simvastatin.” NCT06553157 ↗ “Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis” NCT00127218 ↗ “All statins, e.g. atorvastatin, simvastatin, fluvastatin, rosuvastatin, pravastatin” NCT01634906 ↗ “Fluvastatin 80 mg” NCT01715714 ↗ “Fluvastatin” NCT01563731 ↗ “fluvastatin” NCT01890967 ↗ |
| Known as | fluvastatin (Lescol) | “fluvastatin (Lescol)” NCT00127218 ↗ |
| Known as | fluvastatin XL | “This study was designed to assess the efficacy and tolerability of extended-release fluvastatin (fluvastatin XL) and ezetimibe alone or in combination in patients with previous...” PMID 18312764 ↗ Dec 2007 |
| Known as | Lescol | “one oral dose of fluvastatin (Lescol®) 20mg capsule” NCT04029584 ↗ |
| Action | Inhibit | “statins (HMG CoA reductase inhibitors)” NCT00176410 ↗ |
| Modality | Other / unclassified | “Fluvastatin is a lipid-lowering drugs” NCT01514682 ↗ |
| Route | Oral | “Given orally” NCT00416403 ↗ |