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26 Diseases |  |
7 Trials |
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7 Trials |  |
4331 News |  |
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- | Vascepa (icosapent ethyl) / Amarin
Amarin takes application to expand Vascepa label to the FDA as M&A chatter heats up https://t.co/xanXBGQmIT (Twitter) - Mar 29, 2019
- ||| Vascepa (icosapent ethyl) / Amarin
Great to see icosapent ethyl data from REDUCE-IT added so quickly to ADA #StandardsofCare - ADA Issues Critical Updates to the 2019 Standards of Medical Care in Diabetes https://t.co/NtWcEWydpL @nationallipid @ASPCardio @advcardiohealth @willcefalu @Amarincorp @AmDiabetesAssn (Twitter) - Mar 28, 2019
- ||| Vascepa (icosapent ethyl) / Amarin
Clinical: #Vascepa (icosapent ethyl) is an increasingly obvious no-brainer. ADA gets it. Next up: AHA, FDA, thousands of doctors, and a few tens of millions of patients need to get it. It's too obvious to take very long. It's the dawn of a new era with about 1/3 fewer CV events. $AMRN (Twitter) - Mar 27, 2019
- ||| Vascepa (icosapent ethyl) / Amarin
I'm reading Total Event Analysis from REDUCE-IT Showcases a Substantial Reduction in the Burden of Ischemic Events, Experts Debate Possible Mechanisms of Action of Icosapent Ethyl Presented at ACC 2019, New Orleans, Los Angeles https://t.co/f2SOPnoNFV (Twitter) - Mar 27, 2019
- || Vascepa (icosapent ethyl) / Amarin
That's good news, a testament to the thoroughly compelling work by the REDUCE-IT team. ADA's timely action will save lives. Every day, there are hundreds of preventable #cardiac events in the US alone. Let's hope AHA follows soon. #Vascepa $AMRN. (Twitter) - Mar 27, 2019
- || Vascepa (icosapent ethyl) / Amarin
Congrats on the further data from the study. Balanced critique from ACC too. Wondering if you would consider prescribing Vascepa for primary prevention? (Twitter) - Mar 27, 2019
- || Vascepa (icosapent ethyl) / Amarin
But who would really withhold vascepa just because Ldl is greater than 100?? (Twitter) - Mar 26, 2019
- ||| Vascepa (icosapent ethyl) / Amarin
Clinical: How does Vascepa work, Dr. Deepak ? It reduces CVD by lowering TG ? Is that the unique mechanism? Can you identify the patients who will benefit the most while on treatment? Your fan, Luiz Silva, Rio, Brazil. (Twitter) - Mar 25, 2019
- || icosapent ethyl / Generic mfg.
New P1 trial: VALUE: Vascepa to Accelerate Lipoprotein Uptake and Elimination (clinicaltrials.gov) - Mar 20, 2019
P1, N=0, Active, not recruiting, Sponsor: University of Pennsylvania
- | icosapent ethyl / Generic mfg.
Clinical, Journal: Icosapent Ethyl Effects on Fatty Acid Profiles in Statin-Treated Patients With High Triglycerides: The Randomized, Placebo-controlled ANCHOR Study. (Pubmed Central) - Feb 23, 2019
P3
Icosapent ethyl 4 g/day significantly increased EPA and produced other potentially beneficial shifts in fatty acids in plasma and RBCs versus placebo.
- | icosapent ethyl / Generic mfg.
Enrollment closed, Phase classification: EVAPORATE: Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy (clinicaltrials.gov) - Feb 15, 2019
P4, N=80, Active, not recruiting, Sponsor: Los Angeles Biomedical Research Institute
Icosapent ethyl 4 g/day significantly increased EPA and produced other potentially beneficial shifts in fatty acids in plasma and RBCs versus placebo. Recruiting --> Active, not recruiting | Phase classification: PN/A --> P4
- | icosapent ethyl / Generic mfg.
Clinical Trial,Phase I, Clinical Trial,Phase II, Clinical Trial,Phase III, Journal: Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. (Pubmed Central) - Jan 12, 2019
P3
Among patients with elevated triglyceride levels despite the use of statins, the risk of ischemic events, including cardiovascular death, was significantly lower among those who received 2 g of icosapent ethyl twice daily than among those who received placebo. (Funded by Amarin Pharma; REDUCE-IT ClinicalTrials.gov number, NCT01492361 .).
- | icosapent ethyl / Generic mfg.
Enrollment open, IO biomarker: OMICC: OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer (clinicaltrials.gov) - Nov 30, 2018
P2, N=36, Recruiting, Sponsor: Mingyang Song
(Funded by Amarin Pharma; REDUCE-IT ClinicalTrials.gov number, NCT01492361 .). Not yet recruiting --> Recruiting
- | icosapent ethyl / Generic mfg.
Clinical, Journal: Lipid Effects of Icosapent Ethyl in Women with Diabetes Mellitus and Persistent High Triglycerides on Statin Treatment: ANCHOR Trial Subanalysis. (Pubmed Central) - Nov 13, 2018
In women with DM2 at high CVD risk with persistently high TG on statins, icosapent ethyl 4 g/day reduced potentially atherogenic parameters with safety and tolerability comparable to placebo. Potential CVD benefits of icosapent ethyl are being tested in ∼8000 men and women at high CVD risk with high TG on statins in the ongoing Reduction of Cardiovascular Events with Icosapent Ethyl - Intervention Trial (REDUCE-IT) cardiovascular (CV) outcome trial.
- | icosapent (MND-2119) / Mochida, Amarin
Enrollment open: Efficacy of MND-2119 in Participants With Hypertriglyceridemia (clinicaltrials.gov) - Oct 26, 2018
P3, N=580, Recruiting, Sponsor: Mochida Pharmaceutical Company, Ltd.
Potential CVD benefits of icosapent ethyl are being tested in ∼8000 men and women at high CVD risk with high TG on statins in the ongoing Reduction of Cardiovascular Events with Icosapent Ethyl - Intervention Trial (REDUCE-IT) cardiovascular (CV) outcome trial. Not yet recruiting --> Recruiting
- | icosapent ethyl / Generic mfg.
Trial completion: REDUCE-IT: A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin (clinicaltrials.gov) - Oct 17, 2018
P3, N=8179, Completed, Sponsor: Amarin Pharma Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | icosapent ethyl / Generic mfg.
Trial primary completion date: EVAPORATE: Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy (clinicaltrials.gov) - Oct 16, 2018
P=N/A, N=80, Recruiting, Sponsor: Los Angeles Biomedical Research Institute
Active, not recruiting --> Completed Trial primary completion date: Sep 2018 --> Sep 2019
- | icosapent (MND-2119) / Mochida, Amarin
New P3 trial: Efficacy of MND-2119 in Participants With Hypertriglyceridemia (clinicaltrials.gov) - Oct 2, 2018
P3, N=580, Not yet recruiting, Sponsor: Mochida Pharmaceutical Company, Ltd.
- | icosapent ethyl / Generic mfg.
Trial completion date, Metastases: Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer (clinicaltrials.gov) - Sep 27, 2018
P2, N=96, Recruiting, Sponsor: M.D. Anderson Cancer Center
Trial primary completion date: Sep 2018 --> Sep 2019 Trial completion date: Mar 2023 --> Mar 2022
- | icosapent ethyl / Generic mfg.
New P2 trial, IO biomarker: OMICC: OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer (clinicaltrials.gov) - Sep 7, 2018
P2, N=36, Not yet recruiting, Sponsor: Mingyang Song
- | icosapent ethyl / Generic mfg.
Clinical, Journal: Effect of Vascepa (icosapent ethyl) on progression of coronary atherosclerosis in patients with elevated triglycerides (200-499 mg/dL) on statin therapy: Rationale and design of the EVAPORATE study. (Pubmed Central) - Aug 24, 2018
The clinical implications of icosapent ethyl 4 g/d treatment added to statin therapy on CV endpoints are being evaluated in the large CV outcomes study REDUCE-IT. EVAPORATE will provide important imaging-derived data that may add relevance to the clinically derived outcomes from REDUCE-IT.
- | icosapent ethyl / Generic mfg.
Enrollment open, Trial completion date, Metastases: Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer (clinicaltrials.gov) - Apr 3, 2018
P2, N=96, Recruiting, Sponsor: M.D. Anderson Cancer Center
EVAPORATE will provide important imaging-derived data that may add relevance to the clinically derived outcomes from REDUCE-IT. Active, not recruiting --> Recruiting | Trial completion date: Mar 2022 --> Mar 2023
- |||| icosapent ethyl / Generic mfg.
Trial primary completion date: REDUCE-IT: A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin (clinicaltrials.gov) - Apr 2, 2018
P3, N=8000, Active, not recruiting, Sponsor: Amarin Pharma Inc.
Active, not recruiting --> Recruiting | Trial completion date: Mar 2022 --> Mar 2023 Trial primary completion date: Dec 2017 --> Jul 2018
- |||||||||| icosapent ethyl / Generic mfg.
New P3 trial, Surgery: EMT2: EPA for Metastasis Trial 2 (clinicaltrials.gov) - Feb 9, 2018
P3, N=448, Not yet recruiting, Sponsor: University of Leeds
- | icosapent ethyl / Generic mfg.
Trial primary completion date: EVAPORATE: Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy (clinicaltrials.gov) - Feb 8, 2018
P=N/A, N=80, Recruiting, Sponsor: Los Angeles Biomedical Research Institute
Trial primary completion date: Dec 2017 --> Jul 2018 Trial primary completion date: Sep 2017 --> Sep 2018
- | icosapent ethyl / Generic mfg.
Clinical, Review, Journal: Eicosapentaenoic Acid as a Potential Therapeutic Approach to Reduce Cardiovascular Risk in Patients with End-Stage Renal Disease on Hemodialysis: A Review. (Pubmed Central) - Jan 19, 2018
Three recent studies involving over 800 hemodialysis patients and follow-up of 2-3 years suggest that EPA therapy may improve clinical outcomes in this patient population as evidenced by significant reductions in cardiovascular mortality, all-cause mortality, and/or CV events. Further studies with high-purity EPA are warranted in patients on hemodialysis, especially given the fact that other interventions including antihypertensives, diet, exercise, and statins have not provided meaningful benefit.
- | icosapent ethyl / Generic mfg.
Journal: Icosapent ethyl (eicosapentaenoic acid ethyl ester): Effects on remnant-like particle cholesterol from the MARINE and ANCHOR studies. (Pubmed Central) - Dec 25, 2017
Further studies with high-purity EPA are warranted in patients on hemodialysis, especially given the fact that other interventions including antihypertensives, diet, exercise, and statins have not provided meaningful benefit. Icosapent ethyl 4 g/day significantly reduced calculated and directly measured RLP-C levels versus placebo in patients with elevated TG levels from the MARINE and ANCHOR studies.
- | icosapent ethyl / Generic mfg.
Review, Journal: Icosapent ethyl: Eicosapentaenoic acid concentration and triglyceride-lowering effects across clinical studies. (Pubmed Central) - Nov 8, 2017
In patients with high TG levels (≥200mg/dL) and treated with icosapent ethyl 4g/day, the end-of-treatment plasma and RBC EPA concentrations were >170μg/mL and>70μg/mL, respectively. These studies support icosapent ethyl as producing predictable dose-dependent pharmacokinetics/pharmacodynamics, with TG level lowering dependent upon icosapent ethyl dose and EPA concentrations in plasma and RBCs.
- icosapent ethyl / Generic mfg.
Enrollment closed, Enrollment change, Metastases: Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer (clinicaltrials.gov) - Nov 6, 2017
P2, N=2, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
These studies support icosapent ethyl as producing predictable dose-dependent pharmacokinetics/pharmacodynamics, with TG level lowering dependent upon icosapent ethyl dose and EPA concentrations in plasma and RBCs. Recruiting --> Active, not recruiting | N=96 --> 2
- | icosapent ethyl / Generic mfg.
Journal: Icosapent ethyl (eicosapentaenoic acid ethyl ester): Effects on plasma apolipoprotein C-III levels in patients from the MARINE and ANCHOR studies. (Pubmed Central) - Oct 5, 2017
Recruiting --> Active, not recruiting | N=96 --> 2 Icosapent ethyl 4 g/day significantly reduced plasma ApoC-III levels in patients with elevated TGs from the MARINE and ANCHOR studies.
- | icosapent ethyl / Generic mfg.
Journal: Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial. (Pubmed Central) - Jun 18, 2017
P3
Approximately 8000 patients have been randomized at approximately 470 centers worldwide. Follow-up will continue in this event-driven trial until approximately 1612 adjudicated primary-efficacy endpoint events have occurred.
- | icosapent ethyl / Generic mfg.
Journal: Usefulness of Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) in Women to Lower Triglyceride Levels (Results from the MARINE and ANCHOR Trials). (Pubmed Central) - May 27, 2017
Icosapent ethyl was well tolerated, with adverse-event profiles comparable with findings in the overall studies. In conclusion, icosapent ethyl 4 g/day significantly reduced TG levels and other atherogenic parameters in women without increasing low-density lipoprotein cholesterol levels compared with placebo; the clinical implications of these findings are being evaluated in the REDUCtion of Cardiovascular Events With Eicosapentaenoic Acid [EPA]-Intervention Trial (REDUCE-IT) cardiovascular outcomes study.
- | icosapent ethyl / Generic mfg.
Enrollment change, Trial termination: Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects (clinicaltrials.gov) - Apr 13, 2017
P3, N=9, Terminated, Sponsor: Brigham and Women's Hospital
In conclusion, icosapent ethyl 4 g/day significantly reduced TG levels and other atherogenic parameters in women without increasing low-density lipoprotein cholesterol levels compared with placebo; the clinical implications of these findings are being evaluated in the REDUCtion of Cardiovascular Events With Eicosapentaenoic Acid [EPA]-Intervention Trial (REDUCE-IT) cardiovascular outcomes study. N=33 --> 9 | Recruiting --> Terminated; Difficulty enrolling patients with elevated triglycerides under statin treatment
- |||| icosapent ethyl / Generic mfg.
Enrollment open, Metastases: Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer (clinicaltrials.gov) - Mar 17, 2017
P2, N=96, Recruiting, Sponsor: M.D. Anderson Cancer Center
N=33 --> 9 | Recruiting --> Terminated; Difficulty enrolling patients with elevated triglycerides under statin treatment Not yet recruiting --> Recruiting
- ||| icosapent ethyl / Generic mfg.
Trial initiation date, Trial primary completion date, Metastases: Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer (clinicaltrials.gov) - Feb 24, 2017
P2, N=96, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
Not yet recruiting --> Recruiting Initiation date: Dec 2016 --> Apr 2017 | Trial primary completion date: Dec 2021 --> Apr 2022
- | icosapent ethyl / Generic mfg.
Enrollment open, Preclinical: BRAVE-EPA: Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid (clinicaltrials.gov) - Jan 26, 2017
P2/3, N=150, Recruiting, Sponsor: VA Office of Research and Development
Initiation date: Dec 2016 --> Apr 2017 | Trial primary completion date: Dec 2021 --> Apr 2022 Not yet recruiting --> Recruiting
- ||||| icosapent ethyl / Generic mfg.
New P2 trial, Metastases: Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer (clinicaltrials.gov) - Oct 20, 2016
P2, N=96, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
- | icosapent ethyl / Generic mfg.
Preclinical, Trial initiation date, Trial primary completion date: BRAVE-EPA: Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid (clinicaltrials.gov) - Oct 19, 2016
P2/3, N=150, Not yet recruiting, Sponsor: VA Office of Research and Development
Not yet recruiting --> Recruiting Initiation date: May 2016 --> Dec 2016 | Trial primary completion date: Apr 2021 --> Nov 2021
- icosapent ethyl / Generic mfg.
New trial: EVAPORATE: Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy (clinicaltrials.gov) - Oct 6, 2016
P=N/A, N=80, Recruiting, Sponsor: Los Angeles Biomedical Research Institute
- ||| Epanova (eicosapentaenoic acid/docosahexaenoic acid) / AstraZeneca
New P1 trial: ECLIPSEIII: Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova (clinicaltrials.gov) - Aug 8, 2016
P1, N=114, Completed, Sponsor: AstraZeneca
- | icosapent ethyl / Generic mfg.
Enrollment closed: REDUCE-IT: A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin (clinicaltrials.gov) - Jul 26, 2016
P3, N=8000, Active, not recruiting, Sponsor: Amarin Pharma Inc.
Initiation date: May 2016 --> Dec 2016 | Trial primary completion date: Apr 2021 --> Nov 2021 Recruiting --> Active, not recruiting
- || icosapent ethyl / Generic mfg.
New P2/3 trial, Preclinical: BRAVE-EPA: Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid (clinicaltrials.gov) - Mar 25, 2016
P2/3, N=150, Not yet recruiting, Sponsor: VA Office of Research and Development
- icosapent ethyl / Generic mfg.
Enrollment open: Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects (clinicaltrials.gov) - Mar 18, 2016
P3, N=33, Recruiting, Sponsor: Brigham and Women's Hospital
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- icosapent ethyl / Generic mfg.
New P3 trial: Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects (clinicaltrials.gov) - Apr 21, 2015
P3, N=33, Not yet recruiting, Sponsor: Brigham and Women's Hospital
- aspirin / Generic mfg., pioglitazone / Generic mfg., icosapent ethyl / Generic mfg.
Trial completion: Mediators of Abnormal Reproductive Function in Obesity (MARO) (clinicaltrials.gov) - Mar 17, 2015
P0, N=10, Completed, Sponsor: University of Colorado, Denver
Not yet recruiting --> Recruiting Recruiting --> Completed
- aspirin / Generic mfg., pioglitazone / Generic mfg., icosapent ethyl / Generic mfg.
Trial primary completion date: Mediators of Abnormal Reproductive Function in Obesity (MARO) (clinicaltrials.gov) - Feb 24, 2015
P0, N=27, Recruiting, Sponsor: University of Colorado, Denver
Recruiting --> Completed Trial primary completion date: Mar 2015 --> Sep 2015
- icosapent ethyl / Generic mfg.
Trial primary completion date: REDUCE-IT: A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin (clinicaltrials.gov) - Oct 31, 2014
P3, N=8000, Recruiting, Sponsor: Amarin Pharma Inc.
Trial primary completion date: Mar 2015 --> Sep 2015 Trial primary completion date: Nov 2016 --> Dec 2017
- icosapent ethyl / Generic mfg.
Trial primary completion date: Ethyl-EPA Treatment of Prodromal Patients (clinicaltrials.gov) - May 20, 2014
P2/3, N=7, Completed, Sponsor: Yale University
Trial primary completion date: Nov 2016 --> Dec 2017 Trial primary completion date: Dec 2009 --> Aug 2005
- icosapent ethyl / Generic mfg.
Trial completion date: Ethyl-EPA Treatment of Prodromal Patients (clinicaltrials.gov) - May 20, 2014
P2/3, N=7, Completed, Sponsor: Yale University
Trial primary completion date: Dec 2009 --> Aug 2005 Trial completion date: Dec 2009 --> Aug 2005
- icosapent ethyl / Generic mfg.
Trial completion: Ethyl-EPA Treatment of Prodromal Patients (clinicaltrials.gov) - May 20, 2014
P2/3, N=7, Completed, Sponsor: Yale University
Trial completion date: Dec 2009 --> Aug 2005 Active, not recruiting --> Completed