CLINICAL TRIALS PROFILE FOR VASCEPA
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All Clinical Trials for Vascepa
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| 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. |
| NCT02422446 ↗ | Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects | Terminated | Brigham and Women's Hospital | Phase 3 | 2015-04-01 | This pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid (EPA) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention among adults with elevated triglycerides and type 2 diabetes. |
| 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. |
| NCT02781584 ↗ | Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH) | Completed | Gilead Sciences | Phase 2 | 2016-07-13 | The primary objective of this study is to evaluate the safety and tolerability of selonsertib, firsocostat, cilofexor, fenofibrate and/or Vascepa® in adults with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). |
| NCT02859129 ↗ | Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®) | Completed | AstraZeneca | Phase 1 | 2013-09-01 | This study is intended to evaluate the potential 2-way reciprocal interaction between multiple doses of Epanova™ and a single dose of rosuvastatin |
| NCT02926027 ↗ | Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy | Completed | Intermountain Research and Medical Foundation | Phase 4 | 2017-03-28 | Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons with Elevated Triglycerides (200-499) on Statin Therapy. The study is to determine progression rates of low attenuation plaque under influence of Vascepa as compared to placebo. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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