Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL (MARINE)

Study Description

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Brief Summary:

The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.

Condition or disease	Intervention/treatment	Phase
Hypertriglyceridemia	Drug: AMR101 (ethyl icosapentate); Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	229 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL
Study Start Date :	December 2009
Actual Primary Completion Date :	October 2010
Actual Study Completion Date :	July 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo 4 capsules/day for 12 weeks (Weeks 1-12), then AMR101 (ethyl icosapentate) for 40 weeks (Weeks 13-52)
Experimental: AMR101 (ethyl icosapentate) - 2 g/day	Drug: AMR101 (ethyl icosapentate); AMR101 (ethyl icosapentate) 2 capsules/day for 12 weeks (Weeks 1-12), then AMR101 (ethyl icosapentate) 4 capsules/day for 40 weeks (Weeks 13-52) Drug: Placebo; Placebo 2 capsules/day for 12 weeks (Weeks 1-12)
Experimental: AMR101 (ethyl icosapentate) - 4 g/day	Drug: AMR101 (ethyl icosapentate); AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12), then AMR101 (ethyl icosapentate) 4 capsules/day for 40 weeks (Weeks 13-52)

Outcome Measures

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Primary Outcome Measures :

1. Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in other lipid and biomarker levels [ Time Frame: 12 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Men and women, ages >18
• Fasting triglyceride ≥500 mg/dL and ≤2000 mg/dL
• Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

• Women who are pregnant or lactating, or planning to become pregnant
• 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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 60 Study Locations

Sponsors and Collaborators

Amarin Pharma Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Bays HE et al. Eicosapentaenoic acid ethyl ester (AMR101) therapy in patients with very high triglyceride levels (from the MARINE trial). Am J Cardiol. 2011 Sep 1;108(5):682-90. Epub 2011 Jun 16 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Amarin Pharma Inc.
ClinicalTrials.gov Identifier:	NCT01047683 History of Changes
Other Study ID Numbers:	AMR-01-01-0016
First Posted:	January 13, 2010
Last Update Posted:	January 17, 2014
Last Verified:	December 2013

Keywords provided by Amarin Pharma Inc.:

hypertriglyceridemia; omega-3 fatty acids; statin; triglycerides; lipids; EPA; docosahexaenoic acid; fish; fatty acids; fibrates; niacin; lipid; atorvastatin; Lovaza; simvastatin	lovastatin; pravastatin; fluvastatin; rosuvastatin; Trilipix; Vytorin; Simcor; Niaspan; ezetimibe; Zetia; ethyl-EPA; ethyl icosapentate; Crestor; Zocor; Lipitor

Additional relevant MeSH terms:

Hypertriglyceridemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders	Metabolic Diseases; Eicosapentaenoic acid ethyl ester; Platelet Aggregation Inhibitors