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Last Updated: November 21, 2019

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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 Active, not recruiting 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 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 Impact of Icosapent Ethyl on Alzheimers Disease Biomarkers in Preclinical Adults Not yet recruiting University of Wisconsin, Madison Phase 2/Phase 3 2016-12-01 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 2016-12-01 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.
NCT03428477 EPA for Metastasis Trial 2 Recruiting Amarin Pharma Inc. Phase 3 2018-03-16 A significant proportion of patients who undergo liver surgery to remove bowel cancer that has spread to the liver (metastases) develop disease recurrence and die from the disease. A previous small study (the EMT study) suggested a possible survival benefit in patients who took the naturally-occurring omega-3 fatty acid EPA (a fish oil supplement) before liver surgery. The EMT2 study is a larger study which will recruit 448 men and women with liver metastases from bowel cancer. Trial participants will receive either Icosapent Ethyl (pure EPA derived from fish oil) or placebo (dummy capsules). EMT2 will investigate whether patients who take this supplement before liver surgery and for up to four years after surgery, remain free of recurrence for longer than those who take placebo (dummy capsules)
NCT03428477 EPA for Metastasis Trial 2 Recruiting Yorkshire Cancer Research Phase 3 2018-03-16 A significant proportion of patients who undergo liver surgery to remove bowel cancer that has spread to the liver (metastases) develop disease recurrence and die from the disease. A previous small study (the EMT study) suggested a possible survival benefit in patients who took the naturally-occurring omega-3 fatty acid EPA (a fish oil supplement) before liver surgery. The EMT2 study is a larger study which will recruit 448 men and women with liver metastases from bowel cancer. Trial participants will receive either Icosapent Ethyl (pure EPA derived from fish oil) or placebo (dummy capsules). EMT2 will investigate whether patients who take this supplement before liver surgery and for up to four years after surgery, remain free of recurrence for longer than those who take placebo (dummy capsules)
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Icosapent Ethyl

Condition Name

Condition Name for Icosapent Ethyl
Intervention Trials
Hypertriglyceridemia 2
Colon Cancer 2
Diabetes Mellitus, Non-Insulin-Dependent 1
Cardiovascular Diseases 1
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Condition MeSH

Condition MeSH for Icosapent Ethyl
Intervention Trials
Hypertriglyceridemia 3
Colonic Neoplasms 2
Neoplasm Metastasis 1
Cardiovascular Diseases 1
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Clinical Trial Locations for Icosapent Ethyl

Trials by Country

Trials by Country for Icosapent Ethyl
Location Trials
United States 46
Australia 6
India 6
South Africa 4
Canada 4
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Trials by US State

Trials by US State for Icosapent Ethyl
Location Trials
Massachusetts 2
Louisiana 2
Minnesota 1
Michigan 1
Maryland 1
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Clinical Trial Progress for Icosapent Ethyl

Clinical Trial Phase

Clinical Trial Phase for Icosapent Ethyl
Clinical Trial Phase Trials
Phase 3 3
Phase 2/Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Icosapent Ethyl
Clinical Trial Phase Trials
Recruiting 3
Unknown status 1
Active, not recruiting 1
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Clinical Trial Sponsors for Icosapent Ethyl

Sponsor Name

Sponsor Name for Icosapent Ethyl
Sponsor Trials
Amarin Pharma Inc. 2
Thetis Pharmaceuticals LLC 1
Mingyang Song 1
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Sponsor Type

Sponsor Type for Icosapent Ethyl
Sponsor Trials
Other 6
Industry 3
U.S. Fed 1
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Serving leading biopharmaceutical companies globally:

Colorcon
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