Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
701 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-08-18
Study Completion Date
2022-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The severe acute respiratory syndrome coronavirus 2 (SARS-CoC-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with a high incidence of acute respiratory distress syndrome (ARDS) and death. Aging, obesity, diabetes, hypertension and other risk factors associated with abnormal lipid and carbohydrate metabolism are risk factors for death in COVID-19. Recent studies suggest that COVID-19 progression is dependent on metabolic mechanisms. Moreover, gene expression analyses in cultured human bronchial cells infected with SARS-CoV-2 and lung tissue from patients with COVID-19, indicated a marked shift in cellular metabolism, with excessive intracellular lipid generation. In this cell culture system, fenofibrate (a widely available low-cost generic drug approved by the FDA and multiple other regulatory agencies around the world to treat dyslipemias) at concentrations that can be achieved clinically, markedly inhibited SARS-CoV-2 viral replication. Fenofibrate also has immunomodulatory effects that may be beneficial in the setting of COVID-19. The aim of this trial is to assess the clinical impact of fenofibrate (145 mg/d of Tricor or dose-equivalent preparations for 10 days, with dose adjustment in chronic kidney disease (\[CKD\]) to improve clinical outcomes in patients with COVID-19.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 Survivors - Effect of Fenofibrate
NCT05080192
Covid19
COMPLETED
Lipid Biomarkers for Diabetic Heart Disease
NCT01752842
Type II Diabetes Mellitus
Diabetes Complications
COMPLETED
NA
Study to Evaluate the Effects of MEDI6012 on Apolipoprotein B100 Metabolism
NCT03773172
Cardiovascular Diseases
TERMINATED
PHASE2
A Randomised, Double-Blind, Placebo-Controlled Study Assessing the Effect of Fenofibrate, Coenzyme Q10 and Their co-Administration on Ventricular Diastolic Function in Patients With Type 2 Diabetes
NCT00703482
Patients With Type 2 Diabetes
COMPLETED
PHASE2
Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE
NCT04505774
Covid19
COMPLETED
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Covid19
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fenofibrate + Usual Care
The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation
Group Type
EXPERIMENTAL
Fenofibrate/fenofibric acid
Intervention Type
OTHER
The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days.
Usual care
Intervention Type
OTHER
All participants will otherwise receive usual medical care
Placebo + Usual Care
The randomized intervention will a matching placebo, in combination with usual care.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
The control intervention will be a placebo, for 10 days.
Usual care
Intervention Type
OTHER
All participants will otherwise receive usual medical care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fenofibrate/fenofibric acid
The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days.
Intervention Type
OTHER
Placebo
The control intervention will be a placebo, for 10 days.
Intervention Type
OTHER
Usual care
All participants will otherwise receive usual medical care
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* A diagnosis of COVID-19, based on: (a) A compatible clinical presentation with a positive laboratory test for SARS-CoV-2, or (b) Considered by the primary team to be a Person Under Investigation undergoing testing for COVID-19 with a high clinical probability, in addition to compatible pulmonary infiltrates on chest x-ray (bilateral, intersticial or ground glass opacities) or chest CT.
* Able to provide informed consent.
* Fewer than 14 days since symptom onset.
* Able to provide informed consent.
* Fewer than 14 days since symptom onset.
Exclusion Criteria
* Known pregnancy or breastfeeding
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 or undergoing dialysis (CKD stages 4-5).
* History of active liver disease, cholelithiasis, uncontrolled hypothyroidism, or rhabdomyolysis (suspected or confirmed). Patients with a history of hypothyroidism receiving a stable dose of thyroid replacement therapy for at least 6 weeks, with a documented normal TSH (primary hypothyroidism) or free thyroxine (secondary or tertiary hypothyroidism) level at least 6 weeks after the last dose change will be considered eligible for enrollment.
* Known hypersensitivity to fenofibrate or fenofibric acid.
* Ongoing treatment with fenofibrate, clofibrate, warfarin and other coumarin anticoagulants, glimepiride, cyclosporine, tacrolimus
* Use of statins other than simvastatin, pravastatin or atorvastatin ≤40 mg/d or rosuvastatin ≤20 mg/d
* Prisoners/incarcerated individuals
* Inability to read, write or no access to a smart phone, computer or tablet device
* Intubated patients.
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 or undergoing dialysis (CKD stages 4-5).
* History of active liver disease, cholelithiasis, uncontrolled hypothyroidism, or rhabdomyolysis (suspected or confirmed). Patients with a history of hypothyroidism receiving a stable dose of thyroid replacement therapy for at least 6 weeks, with a documented normal TSH (primary hypothyroidism) or free thyroxine (secondary or tertiary hypothyroidism) level at least 6 weeks after the last dose change will be considered eligible for enrollment.
* Known hypersensitivity to fenofibrate or fenofibric acid.
* Ongoing treatment with fenofibrate, clofibrate, warfarin and other coumarin anticoagulants, glimepiride, cyclosporine, tacrolimus
* Use of statins other than simvastatin, pravastatin or atorvastatin ≤40 mg/d or rosuvastatin ≤20 mg/d
* Prisoners/incarcerated individuals
* Inability to read, write or no access to a smart phone, computer or tablet device
* Intubated patients.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Arizona
OTHER
Sponsor Role
collaborator
Universidad Católica de Santa María
OTHER
Sponsor Role
collaborator
Hospital Nacional Adolfo Guevara Velasco
OTHER
Sponsor Role
collaborator
Hospital Nacional Edgardo Rebagliati Martins
OTHER
Sponsor Role
collaborator
Hospital Nacional Alberto Sabogal Sologuren
OTHER
Sponsor Role
collaborator
Hospital Nacional Guillermo Almenara Irigoyen
OTHER
Sponsor Role
collaborator
Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
OTHER
Sponsor Role
collaborator
Universidad de Santander
OTHER
Sponsor Role
collaborator
National Center for Advancing Translational Sciences (NCATS)
NIH
Sponsor Role
collaborator
Hospital Civil de Guadalajara
OTHER
Sponsor Role
collaborator
Hospital Nacional Dos De Mayo
OTHER
Sponsor Role
collaborator
Hospital Central Fuerza Aérea del Perú
OTHER
Sponsor Role
collaborator
Hospital Militar Central.Coronel Luis Arias Schereiber
OTHER
Sponsor Role
collaborator
Hospital Victor Lazarte Echegaray
OTHER
Sponsor Role
collaborator
University Hospital, Ioannina
OTHER
Sponsor Role
collaborator
AHEPA University Hospital
OTHER
Sponsor Role
collaborator
Sotiria Thoracic Diseases Hospital of Athens
OTHER
Sponsor Role
collaborator
Thriasio General Hospital of Elefsina
OTHER
Sponsor Role
collaborator
University Hospital, Alexandroupolis
OTHER
Sponsor Role
collaborator
G.Gennimatas General Hospital
OTHER
Sponsor Role
collaborator
Biomelab S.A.S.
INDUSTRY
Sponsor Role
collaborator
Fundación Oftalmológica de Santander. Santander, Colombia
OTHER
Sponsor Role
collaborator
IPS Centro Científico Asistencial. Barranquilla, Colombia
OTHER
Sponsor Role
collaborator
Fundación Cardiomet. Quindio, Colombia
OTHER
Sponsor Role
collaborator
ClÍnica de Marly
OTHER
Sponsor Role
collaborator
Clínica Internacional
OTHER
Sponsor Role
collaborator
University of Pennsylvania
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Julio A. Chirinos
Associate Professor of Medicine at the Hospital of the University of Pennsylvania
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Davidson MH, Rooney MW, Drucker J, Eugene Griffin H, Oosman S, Beckert M; LCP-AtorFen Investigators. Efficacy and tolerability of atorvastatin/fenofibrate fixed-dose combination tablet compared with atorvastatin and fenofibrate monotherapies in patients with dyslipidemia: a 12-week, multicenter, double-blind, randomized, parallel-group study. Clin Ther. 2009 Dec;31(12):2824-38. doi: 10.1016/j.clinthera.2009.12.007.
Reference Type
BACKGROUND
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
Reference Type
BACKGROUND
Bornstein SR, Dalan R, Hopkins D, Mingrone G, Boehm BO. Endocrine and metabolic link to coronavirus infection. Nat Rev Endocrinol. 2020 Jun;16(6):297-298. doi: 10.1038/s41574-020-0353-9.
Reference Type
BACKGROUND
Yang JK, Feng Y, Yuan MY, Yuan SY, Fu HJ, Wu BY, Sun GZ, Yang GR, Zhang XL, Wang L, Xu X, Xu XP, Chan JC. Plasma glucose levels and diabetes are independent predictors for mortality and morbidity in patients with SARS. Diabet Med. 2006 Jun;23(6):623-8. doi: 10.1111/j.1464-5491.2006.01861.x.
Reference Type
BACKGROUND
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
Reference Type
BACKGROUND
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
Reference Type
BACKGROUND
Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
Reference Type
BACKGROUND
Zhu L, She ZG, Cheng X, Qin JJ, Zhang XJ, Cai J, Lei F, Wang H, Xie J, Wang W, Li H, Zhang P, Song X, Chen X, Xiang M, Zhang C, Bai L, Xiang D, Chen MM, Liu Y, Yan Y, Liu M, Mao W, Zou J, Liu L, Chen G, Luo P, Xiao B, Zhang C, Zhang Z, Lu Z, Wang J, Lu H, Xia X, Wang D, Liao X, Peng G, Ye P, Yang J, Yuan Y, Huang X, Guo J, Zhang BH, Li H. Association of Blood Glucose Control and Outcomes in Patients with COVID-19 and Pre-existing Type 2 Diabetes. Cell Metab. 2020 Jun 2;31(6):1068-1077.e3. doi: 10.1016/j.cmet.2020.04.021. Epub 2020 May 1.
Reference Type
BACKGROUND
McBride CE, Machamer CE. Palmitoylation of SARS-CoV S protein is necessary for partitioning into detergent-resistant membranes and cell-cell fusion but not interaction with M protein. Virology. 2010 Sep 15;405(1):139-48. doi: 10.1016/j.virol.2010.05.031. Epub 2010 Jul 1.
Reference Type
BACKGROUND
Ehrlich E, Uhl S, Ioannidis K, Hofree M, tenOever B, Nahmias Y. The SARS-CoV-2 Transcriptional Metabolic Signature in Lung Epithelium. Cell Sneak Peak (submission only). 2020
Reference Type
BACKGROUND
Schaefer MB, Pose A, Ott J, Hecker M, Behnk A, Schulz R, Weissmann N, Gunther A, Seeger W, Mayer K. Peroxisome proliferator-activated receptor-alpha reduces inflammation and vascular leakage in a murine model of acute lung injury. Eur Respir J. 2008 Nov;32(5):1344-53. doi: 10.1183/09031936.00035808. Epub 2008 Jul 24.
Reference Type
BACKGROUND
Hecker M, Behnk A, Morty RE, Sommer N, Vadasz I, Herold S, Seeger W, Mayer K. PPAR-alpha activation reduced LPS-induced inflammation in alveolar epithelial cells. Exp Lung Res. 2015;41(7):393-403. doi: 10.3109/01902148.2015.1046200.
Reference Type
BACKGROUND
Huang D, Zhao Q, Liu H, Guo Y, Xu H. PPAR-alpha Agonist WY-14643 Inhibits LPS-Induced Inflammation in Synovial Fibroblasts via NF-kB Pathway. J Mol Neurosci. 2016 Aug;59(4):544-53. doi: 10.1007/s12031-016-0775-y. Epub 2016 Jun 24.
Reference Type
BACKGROUND
Ling H, Luoma JT, Hilleman D. A Review of Currently Available Fenofibrate and Fenofibric Acid Formulations. Cardiol Res. 2013 Apr;4(2):47-55. doi: 10.4021/cr270w. Epub 2013 May 9.
Reference Type
BACKGROUND
Ladabaum U, Mannalithara A, Myer PA, Singh G. Obesity, abdominal obesity, physical activity, and caloric intake in US adults: 1988 to 2010. Am J Med. 2014 Aug;127(8):717-727.e12. doi: 10.1016/j.amjmed.2014.02.026. Epub 2014 Mar 11.
Reference Type
BACKGROUND
O'Connor CM, Whellan DJ, Fiuzat M, Punjabi NM, Tasissa G, Anstrom KJ, Benjafield AV, Woehrle H, Blase AB, Lindenfeld J, Oldenburg O. Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure: The CAT-HF Trial. J Am Coll Cardiol. 2017 Mar 28;69(12):1577-1587. doi: 10.1016/j.jacc.2017.01.041.
Reference Type
BACKGROUND
Margulies KB, Hernandez AF, Redfield MM, Givertz MM, Oliveira GH, Cole R, Mann DL, Whellan DJ, Kiernan MS, Felker GM, McNulty SE, Anstrom KJ, Shah MR, Braunwald E, Cappola TP; NHLBI Heart Failure Clinical Research Network. Effects of Liraglutide on Clinical Stability Among Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):500-8. doi: 10.1001/jama.2016.10260.
Reference Type
BACKGROUND
Felker GM, Maisel AS. A global rank end point for clinical trials in acute heart failure. Circ Heart Fail. 2010 Sep;3(5):643-6. doi: 10.1161/CIRCHEARTFAILURE.109.926030. No abstract available.
Reference Type
BACKGROUND
ACCORD Study Group; Ginsberg HN, Elam MB, Lovato LC, Crouse JR 3rd, Leiter LA, Linz P, Friedewald WT, Buse JB, Gerstein HC, Probstfield J, Grimm RH, Ismail-Beigi F, Bigger JT, Goff DC Jr, Cushman WC, Simons-Morton DG, Byington RP. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1563-74. doi: 10.1056/NEJMoa1001282. Epub 2010 Mar 14.
Reference Type
BACKGROUND
Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
Reference Type
BACKGROUND
Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol. 2005 Apr 20;5:13. doi: 10.1186/1471-2288-5-13.
Reference Type
BACKGROUND
Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.
Reference Type
BACKGROUND
O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.
Reference Type
BACKGROUND
PASS 16 Power Analysis and Sample Size Software. NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass. 2018
Reference Type
BACKGROUND
Fay MP, Malinovsky Y. Confidence intervals of the Mann-Whitney parameter that are compatible with the Wilcoxon-Mann-Whitney test. Stat Med. 2018 Nov 30;37(27):3991-4006. doi: 10.1002/sim.7890. Epub 2018 Jul 8.
Reference Type
BACKGROUND
Willan AR, Pater JL. Carryover and the two-period crossover clinical trial. Biometrics. 1986 Sep;42(3):593-9.
Reference Type
BACKGROUND
Brown BW Jr. The crossover experiment for clinical trials. Biometrics. 1980 Mar;36(1):69-79.
Reference Type
BACKGROUND
GRIZZLE JE. THE TWO-PERIOD CHANGE-OVER DESIGN AN ITS USE IN CLINICAL TRIALS. Biometrics. 1965 Jun;21:467-80. No abstract available.
Reference Type
BACKGROUND
Therneau TM, Grambsch PM. Modeling Survival Data: Extending the Cox Model. In: Statistics for Biology and Health. New York, NY: Springer; 2001
Reference Type
BACKGROUND
Little RJ. Modeling the drop-out mechanism in repeated-measures studies. Journal of the American Statistical Association. 1995;90:1112-1121
Reference Type
BACKGROUND
Li P, Stuart EA, Allison DB. Multiple Imputation: A Flexible Tool for Handling Missing Data. JAMA. 2015 Nov 10;314(18):1966-7. doi: 10.1001/jama.2015.15281. No abstract available.
Reference Type
BACKGROUND
Tahmaz M, Kumbasar B, Ergen K, Ure U, Karatemiz G, Kazancioglu R. Acute renal failure secondary to fenofibrate monotherapy-induced rhabdomyolysis. Ren Fail. 2007;29(7):927-30. doi: 10.1080/08860220701573640.
Reference Type
BACKGROUND
Ghosh B, Sengupta S, Bhattacharjee B, Majumder A, Sarkar SB. Fenofibrate-induced myopathy. Neurol India. 2004 Jun;52(2):268-9.
Reference Type
BACKGROUND
Zhou J, Li D, Cheng Q. Fenofibrate monotherapy-induced rhabdomyolysis in a patient with post-pancreatitis diabetes mellitus: A rare case report and a review of the literature. Medicine (Baltimore). 2020 May 22;99(21):e20390. doi: 10.1097/MD.0000000000020390.
Reference Type
BACKGROUND
Keech A, Simes RJ, Barter P, Best J, Scott R, Taskinen MR, Forder P, Pillai A, Davis T, Glasziou P, Drury P, Kesaniemi YA, Sullivan D, Hunt D, Colman P, d'Emden M, Whiting M, Ehnholm C, Laakso M; FIELD study investigators. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005 Nov 26;366(9500):1849-61. doi: 10.1016/S0140-6736(05)67667-2.
Reference Type
BACKGROUND
Davidson MH. Reducing residual risk for patients on statin therapy: the potential role of combination therapy. Am J Cardiol. 2005 Nov 7;96(9A):3K-13K; discussion 34K-35K. doi: 10.1016/j.amjcard.2005.08.002. Epub 2005 Sep 12.
Reference Type
BACKGROUND
Guo J, Meng F, Ma N, Li C, Ding Z, Wang H, Hou R, Qin Y. Meta-analysis of safety of the coadministration of statin with fenofibrate in patients with combined hyperlipidemia. Am J Cardiol. 2012 Nov 1;110(9):1296-301. doi: 10.1016/j.amjcard.2012.06.050. Epub 2012 Jul 27.
Reference Type
BACKGROUND
Bergman AJ, Murphy G, Burke J, Zhao JJ, Valesky R, Liu L, Lasseter KC, He W, Prueksaritanont T, Qiu Y, Hartford A, Vega JM, Paolini JF. Simvastatin does not have a clinically significant pharmacokinetic interaction with fenofibrate in humans. J Clin Pharmacol. 2004 Sep;44(9):1054-62. doi: 10.1177/0091270004268044.
Reference Type
BACKGROUND
Whitfield LR, Porcari AR, Alvey C, Abel R, Bullen W, Hartman D. Effect of gemfibrozil and fenofibrate on the pharmacokinetics of atorvastatin. J Clin Pharmacol. 2011 Mar;51(3):378-88. doi: 10.1177/0091270010366446. Epub 2010 Apr 22.
Reference Type
BACKGROUND
Patino-Rodriguez O, Martinez-Medina RM, Torres-Roque I, Martinez-Delgado M, Mares-Garcia AS, Escobedo-Moratilla A, Covarrubias-Pinedo A, Arzola-Paniagua A, Herrera-Torres JL, Perez-Urizar J. Absence of a significant pharmacokinetic interaction between atorvastatin and fenofibrate: a randomized, crossover, study of a fixed-dose formulation in healthy Mexican subjects. Front Pharmacol. 2015 Jan 29;6:4. doi: 10.3389/fphar.2015.00004. eCollection 2015.
Reference Type
BACKGROUND
Backman JT, Kyrklund C, Kivisto KT, Wang JS, Neuvonen PJ. Plasma concentrations of active simvastatin acid are increased by gemfibrozil. Clin Pharmacol Ther. 2000 Aug;68(2):122-9. doi: 10.1067/mcp.2000.108507.
Reference Type
BACKGROUND
Kyrklund C, Backman JT, Neuvonen M, Neuvonen PJ. Gemfibrozil increases plasma pravastatin concentrations and reduces pravastatin renal clearance. Clin Pharmacol Ther. 2003 Jun;73(6):538-44. doi: 10.1016/S0009-9236(03)00052-3.
Reference Type
BACKGROUND
Schneck DW, Birmingham BK, Zalikowski JA, Mitchell PD, Wang Y, Martin PD, Lasseter KC, Brown CD, Windass AS, Raza A. The effect of gemfibrozil on the pharmacokinetics of rosuvastatin. Clin Pharmacol Ther. 2004 May;75(5):455-63. doi: 10.1016/j.clpt.2003.12.014.
Reference Type
BACKGROUND
Guiomar V, Oliveira D, Correia C, Pereira E. Efficacy of Rituximab in Refractory Inflammatory Myopathy Associated With Coexistence of Behcet's Disease and Antiphospholipid Syndrome. Eur J Case Rep Intern Med. 2019 Nov 11;6(11):001294. doi: 10.12890/2019_001294. eCollection 2019.
Reference Type
BACKGROUND
Atmaca H, Sayarlioglu H, Kulah E, Demircan N, Akpolat T. Rhabdomyolysis associated with gemfibrozil-colchicine therapy. Ann Pharmacother. 2002 Nov;36(11):1719-21. doi: 10.1345/aph.1C028.
Reference Type
BACKGROUND
Sugie M, Kuriki A, Arai D, Ichikawa H, Kawamura M. [A case report of acute neuromyopathy induced by concomitant use of colchicine and bezafibrate]. No To Shinkei. 2005 Sep;57(9):785-90. Japanese.
Reference Type
BACKGROUND
Feher MD, Hepburn AL, Hogarth MB, Ball SG, Kaye SA. Fenofibrate enhances urate reduction in men treated with allopurinol for hyperuricaemia and gout. Rheumatology (Oxford). 2003 Feb;42(2):321-5. doi: 10.1093/rheumatology/keg103.
Reference Type
BACKGROUND
Schlesinger N. Management of acute and chronic gouty arthritis: present state-of-the-art. Drugs. 2004;64(21):2399-416. doi: 10.2165/00003495-200464210-00003.
Reference Type
BACKGROUND
Lee YH, Lee CH, Lee J. Effect of fenofibrate in combination with urate lowering agents in patients with gout. Korean J Intern Med. 2006 Jun;21(2):89-93. doi: 10.3904/kjim.2006.21.2.89.
Reference Type
BACKGROUND
Jung JY, Choi Y, Suh CH, Yoon D, Kim HA. Effect of fenofibrate on uric acid level in patients with gout. Sci Rep. 2018 Nov 13;8(1):16767. doi: 10.1038/s41598-018-35175-z.
Reference Type
BACKGROUND
Khanna PP. Gout: a patrician malady no more. Lancet Diabetes Endocrinol. 2018 Apr;6(4):263-264. doi: 10.1016/S2213-8587(18)30073-1. No abstract available.
Reference Type
BACKGROUND
Waldman B, Ansquer JC, Sullivan DR, Jenkins AJ, McGill N, Buizen L, Davis TME, Best JD, Li L, Feher MD, Foucher C, Kesaniemi YA, Flack J, d'Emden MC, Scott RS, Hedley J, Gebski V, Keech AC; FIELD investigators. Effect of fenofibrate on uric acid and gout in type 2 diabetes: a post-hoc analysis of the randomised, controlled FIELD study. Lancet Diabetes Endocrinol. 2018 Apr;6(4):310-318. doi: 10.1016/S2213-8587(18)30029-9. Epub 2018 Feb 26.
Reference Type
BACKGROUND
Ting R-D, Keech A. Fenofibrate and renal disease: clinical effects in diabetes. Clinical Lipidology. 2013;8(6):669-680
Reference Type
BACKGROUND
McDonald KB, Garber BG, Perreault MM. Pancreatitis associated with simvastatin plus fenofibrate. Ann Pharmacother. 2002 Feb;36(2):275-9. doi: 10.1345/aph.1A180.
Reference Type
BACKGROUND
Enger C, Gately R, Ming EE, Niemcryk SJ, Williams L, McAfee AT. Pharmacoepidemiology safety study of fibrate and statin concomitant therapy. Am J Cardiol. 2010 Dec 1;106(11):1594-601. doi: 10.1016/j.amjcard.2010.07.041. Epub 2010 Oct 14.
Reference Type
BACKGROUND
Chirinos JA, Lopez-Jaramillo P, Giamarellos-Bourboulis EJ, Davila-Del-Carpio GH, Bizri AR, Andrade-Villanueva JF, Salman O, Cure-Cure C, Rosado-Santander NR, Cornejo Giraldo MP, Gonzalez-Hernandez LA, Moghnieh R, Angeliki R, Cruz Saldarriaga ME, Pariona M, Medina C, Dimitroulis I, Vlachopoulos C, Gutierrez C, Rodriguez-Mori JE, Gomez-Laiton E, Cotrina Pereyra R, Ravelo Hernandez JL, Arbanil H, Accini-Mendoza J, Perez-Mayorga M, Milionis C, Poulakou G, Sanchez G, Valdivia-Vega R, Villavicencio-Carranza M, Ayala-Garcia RJ, Castro-Callirgos CA, Alfaro Carrasco RM, Garrido Lecca Danos W, Sharkoski T, Greene K, Pourmussa B, Greczylo C, Ortega-Legaspi J, Jacoby D, Chittams J, Katsaounou P, Alexiou Z, Sympardi S, Sweitzer NK, Putt M, Cohen JB; FERMIN Investigators. A randomized clinical trial of lipid metabolism modulation with fenofibrate for acute coronavirus disease 2019. Nat Metab. 2022 Dec;4(12):1847-1857. doi: 10.1038/s42255-022-00698-3. Epub 2022 Nov 7.
Reference Type
DERIVED
Chirinos J, Lopez-Jaramillo P, Giamarellos-Bourboulis E, Davila-Del-Carpio G, Bizri A, Andrade-Villanueva J, Salman O, Cure-Cure C, Rosado-Santander N, Giraldo MC, Gonzalez-Hernandez L, Moghnieh R, Angeliki R, Saldarriaga MC, Pariona M, Medina C, Dimitroulis I, Vlachopoulos C, Gutierrez C, Rodriguez-Mori J, Gomez-Laiton E, Pereyra R, Hernandez JR, Arbanil H, Accini-Mendoza J, Perez-Mayorga M, Milionis H, Poulakou G, Sanchez G, Valdivia-Vega R, Villavicencio-Carranza M, Ayala-Garcia R, Castro-Callirgos C, Carrasco RA, Danos WL, Sharkoski T, Greene K, Pourmussa B, Greczylo C, Chittams J, Katsaounou P, Alexiou Z, Sympardi S, Sweitzer N, Putt M, Cohen J. A Randomized Trial of Lipid Metabolism Modulation with Fenofibrate for Acute Coronavirus Disease 2019. Res Sq [Preprint]. 2022 Aug 10:rs.3.rs-1933913. doi: 10.21203/rs.3.rs-1933913/v1.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
843729
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)
NCT03071692
TERMINATED
PHASE3
Retrospective Safety Survey In Patients Included In NV1FGF Clinical Trials
NCT01135797
COMPLETED
Beneficial Effects of Coenzyme Q10 Treatment on the Mitochondrial Dysfunction and Oxidative Stress Associated to Atherothrombosis Developement in Antiphospholipidid Syndrome Patients
NCT02218476
UNKNOWN
NA
Oxford - Fibrates in Aortic Stenosis
NCT05256758
UNKNOWN
NA
Safety and Efficacy Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 Gene Transfer in Patients With Intermittent Claudication
NCT00117650
COMPLETED
PHASE2
Stop Atherosclerosis in Native Diabetics Study
NCT00147251
COMPLETED
PHASE4
The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome
NCT00759291
COMPLETED
PHASE2/PHASE3
Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes
NCT02915198
RECRUITING
PHASE4
Fibroblast Growth Factor-1 (FGF-1) for the Treatment of Coronary Heart Disease
NCT00117936
UNKNOWN
PHASE2
Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen (EFAP)
NCT01089530
COMPLETED
NA
Use of Senolytic and Anti-Fibrotic Agents to Improve the Beneficial Effect of Bone Marrow Stem Cells for Osteoarthritis
NCT04815902
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
Carnosine for Peripheral Arterial Disease
NCT04870229
COMPLETED
PHASE2
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers
NCT02057835
COMPLETED
PHASE1
A STUDY TO LEARN HOW THE STUDY MEDICINE CALLED PF-07293893 AFFECTS MUSCLE BIOMARKERS OF HEALTHY ADULTS
NCT06413693
COMPLETED
PHASE1
Assessment of Atherosclerotic Plaque Characteristics Change by DCE-MRI With Alirocumab
NCT02992301
UNKNOWN
PHASE4
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
NCT02991118
COMPLETED
PHASE3
Influenza A VIRus and Destabilization of Atherosclerotic Carotid Plaques
NCT06217471
COMPLETED
Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension
NCT02981082
TERMINATED
PHASE1
PF-00489791 For The Treatment Of Raynaud's
NCT01090492
COMPLETED
PHASE2
Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy
NCT00352417
COMPLETED
PHASE2
Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events
NCT05537571
COMPLETED
PHASE2
Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction
NCT05711719
COMPLETED
PHASE2
Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia
NCT01963598
COMPLETED
PHASE2
Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease
NCT01157156
COMPLETED
PHASE1
Study of Ruxolitinib Plus Simvastatin in the Prevention and Treatment of Respiratory Failure of COVID-19.
NCT04348695
COMPLETED
PHASE2