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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR VASCEPA

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Clinical Trials for Vascepa

Trial ID Title Status Sponsor Phase 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 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 Recruiting Brigham and Women's Hospital Phase 3 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 Impact of Icosapent Ethyl on Alzheimers Disease Biomarkers in Preclinical Adults Not yet recruiting University of Wisconsin, Madison Phase 2/Phase 3 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 Impact of Icosapent Ethyl on Alzheimers Disease Biomarkers in Preclinical Adults Not yet recruiting VA Office of Research and Development Phase 2/Phase 3 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.
NCT02859129 Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®) Completed AstraZeneca Phase 1 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 Recruiting Intermountain Research and Medical Foundation N/A 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.
NCT02926027 Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy Recruiting Los Angeles Biomedical Research Institute N/A 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 Summary

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Clinical Trial Conditions for Vascepa

Condition Name

Condition Name for Vascepa
Intervention Trials
Hypertriglyceridemia 3
Type 2 Diabetes 1
Liver Metastasis 1
Diabetes Mellitus, Non-Insulin-Dependent 1
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Condition MeSH

Condition MeSH for Vascepa
Intervention Trials
Hypertriglyceridemia 3
Myocardial Ischemia 2
Coronary Artery Disease 2
Diabetes Mellitus 1
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Clinical Trial Locations for Vascepa

Trials by Country

Trials by Country for Vascepa
Location Trials
United States 6
United Kingdom 2
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Trials by US State

Trials by US State for Vascepa
Location Trials
Massachusetts 1
Louisiana 1
Utah 1
California 1
New Jersey 1
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Clinical Trial Progress for Vascepa

Clinical Trial Phase

Clinical Trial Phase for Vascepa
Clinical Trial Phase Trials
Phase 3 2
Phase 2/Phase 3 1
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Vascepa
Clinical Trial Phase Trials
Recruiting 3
Not yet recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Vascepa

Sponsor Name

Sponsor Name for Vascepa
Sponsor Trials
Thetis Pharmaceuticals LLC 1
Los Angeles Biomedical Research Institute 1
Intermountain Research and Medical Foundation 1
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Sponsor Type

Sponsor Type for Vascepa
Sponsor Trials
Other 6
Industry 3
U.S. Fed 1
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