CLINICAL TRIALS PROFILE FOR ICOSAPENT ETHYL
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All Clinical Trials for icosapent ethyl
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01492361 ↗ | A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major | Completed | Amarin Pharma Inc. | Phase 3 | 2011-11-01 | AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) being developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study is to evaluate whether this drug, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia. |
| NCT02113163 ↗ | PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA | Unknown status | Thetis Pharmaceuticals LLC | Phase 1 | 2014-03-01 | The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to evaluate the safety and tolerability of single and repeat single doses of TP-101. |
| NCT02719327 ↗ | Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid | Active, not recruiting | University of Wisconsin, Madison | Phase 2/Phase 3 | 2017-06-08 | The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by 2050. Compared to the general population, Veterans have a greater risk of AD, likely in part due to their increased incidence of traumatic brain injury, post-traumatic stress disorder, depression, and other vascular-related health issues. Based on available data, 423,000 new cases of AD are anticipated in Veterans by 2020. Thus, the discovery of effective therapies to prevent or delay the onset of AD in Veterans is critical. The goal of this study is to evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD would be reduced by 50% in this population and could have a profound effect on Veteran quality of life and healthcare costs. |
| NCT02719327 ↗ | Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid | Active, not recruiting | VA Office of Research and Development | Phase 2/Phase 3 | 2017-06-08 | The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by 2050. Compared to the general population, Veterans have a greater risk of AD, likely in part due to their increased incidence of traumatic brain injury, post-traumatic stress disorder, depression, and other vascular-related health issues. Based on available data, 423,000 new cases of AD are anticipated in Veterans by 2020. Thus, the discovery of effective therapies to prevent or delay the onset of AD in Veterans is critical. The goal of this study is to evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD would be reduced by 50% in this population and could have a profound effect on Veteran quality of life and healthcare costs. |
| NCT02940223 ↗ | Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer | Terminated | Bayer | Phase 2 | 2017-03-16 | This randomized phase II trial studies how well ethyl icosapentate and physical activity work in treating fatigue in patients with cancer that has spread from where it started to other places in the body. Ethyl icosapentate and physical activity may provide more robust and clinically effective improvement of cancer related fatigue, which may facilitate patients continuing cancer therapy since it would be tolerated and effective in controlling disease. |
| NCT02940223 ↗ | Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer | Terminated | National Cancer Institute (NCI) | Phase 2 | 2017-03-16 | This randomized phase II trial studies how well ethyl icosapentate and physical activity work in treating fatigue in patients with cancer that has spread from where it started to other places in the body. Ethyl icosapentate and physical activity may provide more robust and clinically effective improvement of cancer related fatigue, which may facilitate patients continuing cancer therapy since it would be tolerated and effective in controlling disease. |
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