Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
NCT ID: NCT01047683
Last Updated: 2022-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
229 participants
INTERVENTIONAL
2009-12-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo 4 capsules/day for 12 weeks (Weeks 1-12)
AMR101 (ethyl icosapentate) - 2 g/day
AMR101 (ethyl icosapentate) - 2 g/day
AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)
AMR101 (ethyl icosapentate) - 4 g/day
AMR101 (ethyl icosapentate) - 4 g/day
AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)
Interventions
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AMR101 (ethyl icosapentate) - 4 g/day
AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)
AMR101 (ethyl icosapentate) - 2 g/day
AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)
Placebo
Placebo 4 capsules/day for 12 weeks (Weeks 1-12)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fasting triglyceride ≥500 mg/dL and ≤2000 mg/dL
* Provide written informed consent and authorization for protected health information disclosure
Exclusion Criteria
* Use of non-statin lipid-altering drugs which cannot be stopped including fibrates, niacin, fish oil and other products containing omega-3 fatty acids or other dietary supplements with potential lipid-altering effects
* History of pancreatitis
* History of bariatric surgery or currently on weight loss drugs
* Uncontrolled hypertension (BP \> 160/100)
* HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or isotretinoin
* Consumption of more than 2 alcoholic beverages per day
* History of cancers (except if been disease free for \>5 years OR history was basal or squamous cell skin cancer)
* Participation in another clinical trial involving an investigational agent in the last 30 days
* Other parameters will be assessed at the study center to ensure eligibility for this study.
18 Years
ALL
No
Sponsors
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Amarin Pharma Inc.
INDUSTRY
Responsible Party
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Locations
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Amarin Investigational Site
Sacramento, California, United States
Amarin Investigational Site
Golden, Colorado, United States
Amarin Investigational Site
Miami, Florida, United States
Amarin Investigational Site
Miami, Florida, United States
Amarin Investigational Site
Ocala, Florida, United States
Amarin Investigational Site
Addison, Illinois, United States
Amarin Investigational Site
Chicago, Illinois, United States
Amarin Investigational Site
Louisville, Kentucky, United States
Amarin Investigational Site
Butte, Montana, United States
Amarin Investigational Site
Raleigh, North Carolina, United States
Amarin Investigational Site
Winston-Salem, North Carolina, United States
Amarin Investigational Site
Cincinnati, Ohio, United States
Amarin Investigational Site
Cincinnati, Ohio, United States
Amarin Investigational Site
Lyndhurst, Ohio, United States
Amarin Investigational Site
Tulsa, Oklahoma, United States
Amarin Investigational Site
Corpus Christi, Texas, United States
Amarin Investigational Site
Houston, Texas, United States
Amarin Investigational Site
Richmond, Virginia, United States
Amarin Investigational Site
Aalborg, , Denmark
Amarin Investigational Site
Herlev, , Denmark
Amarin Investigational Site
Oulu, , Finland
Amarin Investigational Site
Dresden, , Germany
Amarin Investigational Site
Giessen, , Germany
Amarin Investigational Site
Magdeburg, , Germany
Amarin Investigational Site
München, , Germany
Amarin Investigational Site
München, , Germany
Amarin Investigational Site
Nuremberg, , Germany
Amarin Investigational Site
Ahmedabad, , India
Amarin Investigational Site
Bangalore, , India
Amarin Investigational Site
Bangalore, , India
Amarin Investigational Site
Bangalore, , India
Amarin Investigational Site
Gopālapuram, , India
Amarin Investigational Site
Indore, , India
Amarin Investigational Site
Mysore, , India
Amarin Investigational Site
Genova, , Italy
Amarin Investigational Site
Palermo, , Italy
Amarin Investigational Site
Guadalajara, Jalisco, , Mexico
Amarin Investigational Site
Mexico City, , Mexico
Amarin Investigational Site
Mexico City, , Mexico
Amarin Investigational Site
Monterrey Nuevo Leon, , Mexico
Amarin Investigational Site
Amsterdam, , Netherlands
Amarin Investigational Site
Groningen, , Netherlands
Amarin Investigational Site
Rotterdam, , Netherlands
Amarin Investigational Site
Rotterdam, , Netherlands
Amarin Investigational Site
Utrecht, , Netherlands
Amarin Investigational Site
Moscow, , Russia
Amarin Investigational Site
Moscow, , Russia
Amarin Investigational Site
Saint Petersburg, , Russia
Amarin Investigational Site
Saint Petersburg, , Russia
Amarin Investigational Site
Saint Petersburg, , Russia
Amarin Investigational Site
Bloemfontein, , South Africa
Amarin Investigational Site
Cape Town, , South Africa
Amarin Investigational Site
Johannesburg, , South Africa
Amarin Investigational Site
Parktown, , South Africa
Amarin Investigational Site
Pretoria, , South Africa
Amarin Investigational Site
Somerset West, , South Africa
Amarin Investigational Site
Ivano-Frankivsk, , Ukraine
Amarin Investigational Site
Kiev, , Ukraine
Amarin Investigational Site
Kyiv, , Ukraine
Amarin Investigational Site
Odesa, , Ukraine
Countries
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References
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Bays HE, Ballantyne CM, Kastelein JJ, Isaacsohn JL, Braeckman RA, Soni PN. Eicosapentaenoic acid ethyl ester (AMR101) therapy in patients with very high triglyceride levels (from the Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension [MARINE] trial). Am J Cardiol. 2011 Sep 1;108(5):682-90. doi: 10.1016/j.amjcard.2011.04.015. Epub 2011 Jun 16.
Bays HE, Braeckman RA, Ballantyne CM, Kastelein JJ, Otvos JD, Stirtan WG, Soni PN. Icosapent ethyl, a pure EPA omega-3 fatty acid: effects on lipoprotein particle concentration and size in patients with very high triglyceride levels (the MARINE study). J Clin Lipidol. 2012 Nov-Dec;6(6):565-72. doi: 10.1016/j.jacl.2012.07.001. Epub 2012 Jul 24.
Bays HE, Ballantyne CM, Braeckman RA, Stirtan WG, Soni PN. Icosapent ethyl, a pure ethyl ester of eicosapentaenoic acid: effects on circulating markers of inflammation from the MARINE and ANCHOR studies. Am J Cardiovasc Drugs. 2013 Feb;13(1):37-46. doi: 10.1007/s40256-012-0002-3.
Braeckman RA, Manku MS, Bays HE, Stirtan WG, Soni PN. Icosapent ethyl, a pure EPA omega-3 fatty acid: effects on plasma and red blood cell fatty acids in patients with very high triglyceride levels (results from the MARINE study). Prostaglandins Leukot Essent Fatty Acids. 2013 Sep;89(4):195-201. doi: 10.1016/j.plefa.2013.07.005. Epub 2013 Aug 1.
Bays HE, Ballantyne CM, Braeckman RA, Stirtan WG, Doyle RT Jr, Philip S, Soni PN, Juliano RA. Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester): Effects Upon High-Sensitivity C-Reactive Protein and Lipid Parameters in Patients With Metabolic Syndrome. Metab Syndr Relat Disord. 2015 Aug;13(6):239-47. doi: 10.1089/met.2014.0137. Epub 2015 Apr 20.
Ballantyne CM, Bays HE, Braeckman RA, Philip S, Stirtan WG, Doyle RT Jr, Soni PN, Juliano RA. Icosapent ethyl (eicosapentaenoic acid ethyl ester): Effects on plasma apolipoprotein C-III levels in patients from the MARINE and ANCHOR studies. J Clin Lipidol. 2016 May-Jun;10(3):635-645.e1. doi: 10.1016/j.jacl.2016.02.008. Epub 2016 Feb 23.
Ballantyne CM, Bays HE, Philip S, Doyle RT Jr, Braeckman RA, Stirtan WG, Soni PN, Juliano RA. Icosapent ethyl (eicosapentaenoic acid ethyl ester): Effects on remnant-like particle cholesterol from the MARINE and ANCHOR studies. Atherosclerosis. 2016 Oct;253:81-87. doi: 10.1016/j.atherosclerosis.2016.08.005. Epub 2016 Aug 20.
Bays HE, Ballantyne CM, Doyle RT Jr, Juliano RA, Philip S. Icosapent ethyl: Eicosapentaenoic acid concentration and triglyceride-lowering effects across clinical studies. Prostaglandins Other Lipid Mediat. 2016 Sep;125:57-64. doi: 10.1016/j.prostaglandins.2016.07.007. Epub 2016 Jul 11.
Mosca L, Ballantyne CM, Bays HE, Guyton JR, Philip S, Doyle RT Jr, Juliano RA. Usefulness of Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) in Women to Lower Triglyceride Levels (Results from the MARINE and ANCHOR Trials). Am J Cardiol. 2017 Feb 1;119(3):397-403. doi: 10.1016/j.amjcard.2016.10.027. Epub 2016 Nov 1.
Other Identifiers
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The MARINE Study
Identifier Type: OTHER
Identifier Source: secondary_id
AMR-01-01-0016
Identifier Type: -
Identifier Source: org_study_id
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