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  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Anti-Hypertensive Action of Fenofibrate via UCP2 Upregulation Mediated by PPAR Activation in Baroreflex Afferent Pathway. (Pubmed Central) -  Apr 11, 2019   
    Expression of the downstream signaling molecule of PPAR-α, the mitochondrial uncoupling protein 2 (UCP2), was up-regulated in the baroreflex afferent pathway under similar experimental conditions, along with amelioration of reduced superoxide dismutase activity and increased superoxide in HFD rats. These results suggest that chronic treatment with fenofibrate plays a crucial role in the neural control of blood pressure by improving baroreflex afferent function due at least partially to PPAR-mediated up-regulation of UCP2 expression and reduction of oxidative stress.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Fenofibrate Exerts Protective Effects in Diabetic Retinopathy via Inhibition of the ANGPTL3 Pathway. (Pubmed Central) -  Apr 7, 2019   
    However, expression levels of the above markers were downregulated following fenofibrate intervention, blockage of integrin αVβ3 receptor, or ANGPTL3 siRNA interference. We identified fenofibrate exerts its protective effects by inhibiting ANGPTL3-induced apoptosis and inflammation in diabetic retinopathy, which is a novel mechanism.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Stilbenoids and cannabinoids from the leaves of Cannabis sativa f. sativa with potential reverse cholesterol transport activity. (Pubmed Central) -  Apr 5, 2019   
    ...They could improve [3H]-cholesterol efflux from Raw 264.7 macrophages to high density lipoproteins by enhancing the protein expression of ABCG1 and SR-B1, and HM1 and HM2 showed a significant difference compared with fenofibrate at 1.0 mg L-1...In conclusion, HM1 showed lower cytotoxicity and higher activity in improving the RCT-related protein expression. Our study suggests that it may be explored as a novel lipid-lowering drug and as a beneficial ingredient in health functional foods and pharmaceuticals.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Preclinical, Journal:  Fenofibrate improves vascular endothelial function and contractility in diabetic mice. (Pubmed Central) -  Apr 3, 2019   
    Finally, incubation with indomethacin in vitro improved aortic contractility in diabetic mice. Overall, our results show that fenofibrate treatment in diabetic mice normalizes endothelial function by balancing vascular reactivity via increasing NO production and suppressing the vasoconstrictor prostaglandin, suggesting mechanism of action of fenofibrate in mediating diabetic vascular complications.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  The effects of proprotein convertase subtilisin/kexin type 9 inhibitors on lipid metabolism and cardiovascular function. (Pubmed Central) -  Mar 29, 2019   
    ...Although there are several developed lipid lowering drugs such as statins and fenofibrates, many patients do not achieve an adequate response...This review comprehensively summarizes and discusses the effects of PCSK9 inhibitors on lipid metabolism and cardiovascular function comparatively with current lipid lowering drugs. This review also details essential information regarding the cardiovascular benefits of PCSK9 inhibition which could encourage further clinical studies.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Biomarker, Preclinical, Journal:  Mate tea reduces high fat diet-induced liver and metabolic disorders in mice. (Pubmed Central) -  Mar 28, 2019   
    ...A separate group of mice was treated with fenofibrate as a positive control (a regular drug for lipid disorders)...Treatment also prevented adiponectin increase. Mate tea may be a good resource to reduce hepatic steatosis in the future since it has anti-diabetic, anti-inflammatory and antioxidant effects, which prevent the accumulation of fat in the liver.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Preclinical, Journal:  Acetyl-CoA Carboxylase Inhibition Reverses NAFLD and Hepatic Insulin Resistance but Promotes Hypertriglyceridemia in Rodents. (Pubmed Central) -  Mar 25, 2019   
    At the molecular level, these changes were associated with increases in LXR/SREBP1 and decreases in PPARα target activation and could be reversed with fenofibrate co-treatment in a high-fat diet mouse model. Collectively, these studies warrant further investigation into the therapeutic utility of liver-directed ACC inhibition for the treatment of NAFLD and hepatic insulin resistance.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Biomarker, Enrollment change:  Lipid Biomarkers for Diabetic Heart Disease (clinicaltrials.gov) -  Feb 26, 2019   
    P=N/A,  N=70, Completed, 
    All these results indicated that the polymer/SLS interaction would affect the performance of SDs; hence, it was necessary to study their properties in the preformulation. N=114 --> 70
  • ||||||||||  micronized fenofibrate / Generic mfg., fenofibrate / Generic mfg.
    Biomarker, Enrollment open:  Fenofibrate in Type 2 Diabetes (clinicaltrials.gov) -  Feb 6, 2019   
    P4,  N=40, Recruiting, 
    N=114 --> 70 Not yet recruiting --> Recruiting
  • ||||||||||  micronized fenofibrate / Generic mfg., fenofibrate / Generic mfg.
    Biomarker, New P4 trial:  Fenofibrate in Type 2 Diabetes (clinicaltrials.gov) -  Feb 4, 2019   
    P4,  N=40, Not yet recruiting, 
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Clinical, Journal:  Associations of Fenofibrate Therapy With Incidence and Progression of CKD in Patients With Type 2 Diabetes. (Pubmed Central) -  Jan 1, 2019   
    There was no difference in incidence of CKD (HR 0.92, 95% CI 0.74-1.15, P = 0.46) and/or kidney failure (HR 0.95, 95% CI 0.68-1.33, P = 0.76). Compared with placebo, randomization to fenofibrate was associated with lower rates of incident albuminuria and a slower eGFR decline, but no difference in incidence of CKD or kidney failure in ACCORD participants.
  • ||||||||||  Flutiform (fluticasone/formoterol) / Kyorin, Mundipharma, Vectura, Sanofi
    Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date, Adherence:  Flutiform in Treatment of Patients With Asthma in Daily Clinical Practice. (clinicaltrials.gov) -  Nov 16, 2018   
    P=N/A,  N=0, Withdrawn, 
    Compared with placebo, randomization to fenofibrate was associated with lower rates of incident albuminuria and a slower eGFR decline, but no difference in incidence of CKD or kidney failure in ACCORD participants. N=250 --> 0 | Trial completion date: Nov 2018 --> Dec 2016 | Not yet recruiting --> Withdrawn | Trial primary completion date: Mar 2018 --> Dec 2016
  • ||||||||||  DV281 / Dynavax
    Enrollment change, Combination therapy, PD(L)-1 Biomarker, Metastases:  Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC (clinicaltrials.gov) -  Oct 16, 2018   
    P1b,  N=167, Recruiting, 
    N=250 --> 0 | Trial completion date: Nov 2018 --> Dec 2016 | Not yet recruiting --> Withdrawn | Trial primary completion date: Mar 2018 --> Dec 2016 N=80 --> 167
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Biomarker, Trial completion, Trial completion date:  Lipid Biomarkers for Diabetic Heart Disease (clinicaltrials.gov) -  Jun 13, 2018   
    P=N/A,  N=114, Completed, 
    Recruiting --> Completed | N=12 --> 17 Active, not recruiting --> Completed | Trial completion date: Feb 2019 --> Feb 2018
  • ||||||||||  Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
    Enrollment closed, Trial initiation date:  A Long-term Safety Study of QVM149 in Japanese Patients With Asthma (clinicaltrials.gov) -  Mar 9, 2018   
    P3,  N=93, Active, not recruiting, 
    Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Initiation date: Apr 2017 --> Oct 2016
  • ||||||||||  Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
    Trial completion date, Trial initiation date, Trial primary completion date:  IRIDIUM: Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma (clinicaltrials.gov) -  Mar 7, 2018   
    P3,  N=2980, Recruiting, 
    Recruiting --> Active, not recruiting | Initiation date: Apr 2017 --> Oct 2016 Trial completion date: Apr 2019 --> Jun 2019 | Initiation date: Dec 2015 --> Feb 2015 | Trial primary completion date: Apr 2019 --> Jun 2019
  • ||||||||||  Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
    Trial initiation date, Trial primary completion date, Head-to-Head:  ARGON: Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium (clinicaltrials.gov) -  Mar 3, 2018   
    P3,  N=1500, Not yet recruiting, 
    Trial completion date: Apr 2019 --> Jun 2019 | Initiation date: Dec 2015 --> Feb 2015 | Trial primary completion date: Apr 2019 --> Jun 2019 Initiation date: Jan 2018 --> Feb 2018 | Trial primary completion date: Mar 2019 --> Jun 2019
  • ||||||||||  Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Trial completion, Trial completion date, Trial initiation date, Trial primary completion date:  Bronchodilator Effects and Safety of Glycopyrronium Bromide (25 ug and 50 ug o.d.) in Asthma (clinicaltrials.gov) -  Feb 15, 2018   
    P2/3,  N=148, Completed, 
    Not yet recruiting --> Recruiting | Trial completion date: Jul 2018 --> Aug 2018 | Initiation date: May 2017 --> May 2017 | Trial primary completion date: Jul 2018 --> Aug 2018 Not yet recruiting --> Completed | Trial primary completion date: Apr 2018 --> Dec 2017 | Trial completion date: Apr 2018 --> Dec 2017 | Initiation date: May 2017 --> May 2017
  • ||||||||||  Dupixent (dupilumab) / Sanofi, Regeneron
    Trial completion:  EXPEDITION: Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma (clinicaltrials.gov) -  Jan 31, 2018   
    P2,  N=42, Completed, 
    Not yet recruiting --> Completed | Trial primary completion date: Apr 2018 --> Dec 2017 | Trial completion date: Apr 2018 --> Dec 2017 | Initiation date: May 2017 --> May 2017 Active, not recruiting --> Completed
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Biomarker, Enrollment closed:  Lipid Biomarkers for Diabetic Heart Disease (clinicaltrials.gov) -  Jan 8, 2018   
    P=N/A,  N=114, Active, not recruiting, 
    Initiation date: Jun 2017 --> Jan 2017 Recruiting --> Active, not recruiting
  • ||||||||||  Dupixent (dupilumab) / Sanofi, Regeneron
    Enrollment closed:  EXPEDITION: Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma (clinicaltrials.gov) -  Dec 20, 2017   
    P2,  N=42, Active, not recruiting, 
    Our results provide promise for developing this combination clinically and others that combine 2-DG with agents that act synergistically to selectively increase energy and ER stress to a level that is toxic to numerous tumor cell types. Recruiting --> Active, not recruiting
  • ||||||||||  DV281 / Dynavax
    New P1 trial, Combination therapy, PD(L)-1 Biomarker, Metastases:  Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC (clinicaltrials.gov) -  Oct 31, 2017   
    P1b,  N=80, Recruiting, 
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi, Xenical (orlistat) / Roche, GSK
    Journal:  Type 1 hyperlipoproteinemia in a child with large homozygous deletion encompassing GPIHBP1. (Pubmed Central) -  Oct 12, 2017   
    Extreme hypertriglyceridemia failed to respond to treatment with fenofibrate, fish oil, and orlistat...We highlight the need to perform copy number variations analysis of whole-exome sequencing data for finding disease-causing variants. There is also an urgent need to develop novel targeted therapies for patients with T1HLP.
  • ||||||||||  Flutiform (fluticasone/formoterol) / Kyorin, Mundipharma, Vectura, Sanofi
    Trial completion, Trial primary completion date:  A Study to Show That Flutiform is Well Tolerated and Effective in the Treatment of COPD (clinicaltrials.gov) -  Aug 31, 2017   
    P3,  N=1767, Completed, 
    There is also an urgent need to develop novel targeted therapies for patients with T1HLP. Active, not recruiting --> Completed | Trial primary completion date: Apr 2015 --> Apr 2016
  • ||||||||||  Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
    Enrollment open, Trial primary completion date:  A Long-term Safety Study of QVM149 in Japanese Patients With Asthma (clinicaltrials.gov) -  May 18, 2017   
    P3,  N=100, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial primary completion date: May 2019 --> Nov 2018
  • ||||||||||  Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
    Trial primary completion date:  IRIDIUM: Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma (clinicaltrials.gov) -  May 3, 2017   
    P3,  N=2980, Recruiting, 
    Recruiting --> Completed | N=66 --> 15 Trial primary completion date: Oct 2018 --> Apr 2019
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Biomarker, Trial primary completion date:  Lipid Biomarkers for Diabetic Heart Disease (clinicaltrials.gov) -  Apr 7, 2017   
    P=N/A,  N=104, Recruiting, 
    Trial primary completion date: Oct 2018 --> Apr 2019 Trial primary completion date: Mar 2017 --> Feb 2018