search
Back to results

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

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AMR101 (ethyl icosapentate) - 4 g/day
AMR101 (ethyl icosapentate) - 2 g/day
Placebo
Sponsored by
Amarin Pharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring 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, ezetimibe, Zetia, ethyl-EPA, ethyl icosapentate, Crestor, Zocor, Lipitor, Niaspan, LDL, HDL, cholesterol, dyslipidemia, VASCEPA, icosapent ethyl

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site
  • Amarin Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

AMR101 (ethyl icosapentate) - 2 g/day

AMR101 (ethyl icosapentate) - 4 g/day

Arm Description

Outcomes

Primary Outcome Measures

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect
Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day

Secondary Outcome Measures

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels
Median percent change from baseline to Week 12 in serum very low-density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels
Median percent change from baseline to Week 12 in serum Lipoprotein-associated Phospholipase A2 levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels
Median in percent change from baseline to Week 12 in serum Apolipoprotein B levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day

Full Information

First Posted
January 11, 2010
Last Updated
March 28, 2022
Sponsor
Amarin Pharma Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01047683
Brief Title
Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
Acronym
MARINE
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 Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amarin Pharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
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, ezetimibe, Zetia, ethyl-EPA, ethyl icosapentate, Crestor, Zocor, Lipitor, Niaspan, LDL, HDL, cholesterol, dyslipidemia, VASCEPA, icosapent ethyl

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
AMR101 (ethyl icosapentate) - 2 g/day
Arm Type
Experimental
Arm Title
AMR101 (ethyl icosapentate) - 4 g/day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AMR101 (ethyl icosapentate) - 4 g/day
Other Intervention Name(s)
VASCEPA® (icosapent ethyl)
Intervention Description
AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)
Intervention Type
Drug
Intervention Name(s)
AMR101 (ethyl icosapentate) - 2 g/day
Other Intervention Name(s)
VASCEPA® (icosapent ethyl)
Intervention Description
AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 4 capsules/day for 12 weeks (Weeks 1-12)
Primary Outcome Measure Information:
Title
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect
Description
Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels
Description
Median percent change from baseline to Week 12 in serum very low-density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
Time Frame
baseline and 12 weeks
Title
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels
Description
Median percent change from baseline to Week 12 in serum Lipoprotein-associated Phospholipase A2 levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
Time Frame
baseline and 12 weeks
Title
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels
Description
Median in percent change from baseline to Week 12 in serum Apolipoprotein B levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
Time Frame
baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels
Description
Median percent change from baseline to Week 12 in serum low density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
Time Frame
baseline and 12 weeks
Title
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels
Description
Median percent change from baseline to Week 12 in serum non-high density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
Time Frame
baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Amarin Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Amarin Investigational Site
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Amarin Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Amarin Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Amarin Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Amarin Investigational Site
City
Addison
State/Province
Illinois
ZIP/Postal Code
27106
Country
United States
Facility Name
Amarin Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Amarin Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Amarin Investigational Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Amarin Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27527
Country
United States
Facility Name
Amarin Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Amarin Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Amarin Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Amarin Investigational Site
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Amarin Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Amarin Investigational Site
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Amarin Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Amarin Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Amarin Investigational Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Amarin Investigational Site
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Amarin Investigational Site
City
Oulu
ZIP/Postal Code
FI-90014
Country
Finland
Facility Name
Amarin Investigational Site
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Amarin Investigational Site
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Amarin Investigational Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Amarin Investigational Site
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Amarin Investigational Site
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Amarin Investigational Site
City
Nuernberg
ZIP/Postal Code
90402
Country
Germany
Facility Name
Amarin Investigational Site
City
Ahmedabad
ZIP/Postal Code
380 015
Country
India
Facility Name
Amarin Investigational Site
City
Bangalore
ZIP/Postal Code
560003
Country
India
Facility Name
Amarin Investigational Site
City
Bangalore
ZIP/Postal Code
560010
Country
India
Facility Name
Amarin Investigational Site
City
Bangalore
ZIP/Postal Code
560054
Country
India
Facility Name
Amarin Investigational Site
City
Gopalapuram
ZIP/Postal Code
600086
Country
India
Facility Name
Amarin Investigational Site
City
Indore
ZIP/Postal Code
452010
Country
India
Facility Name
Amarin Investigational Site
City
Mysore
ZIP/Postal Code
570 020
Country
India
Facility Name
Amarin Investigational Site
City
Genova
ZIP/Postal Code
I-16132
Country
Italy
Facility Name
Amarin Investigational Site
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Amarin Investigational Site
City
Guadalajara, Jalisco
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Amarin Investigational Site
City
Mexico City
ZIP/Postal Code
11650
Country
Mexico
Facility Name
Amarin Investigational Site
City
Mexico City
ZIP/Postal Code
6700
Country
Mexico
Facility Name
Amarin Investigational Site
City
Monterrey Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Amarin Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Amarin Investigational Site
City
Groningen
ZIP/Postal Code
9711 SG
Country
Netherlands
Facility Name
Amarin Investigational Site
City
Rotterdam
ZIP/Postal Code
3021 HC
Country
Netherlands
Facility Name
Amarin Investigational Site
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Amarin Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Amarin Investigational Site
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Amarin Investigational Site
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
Amarin Investigational Site
City
St Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Amarin Investigational Site
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Amarin Investigational Site
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Amarin Investigational Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Amarin Investigational Site
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Amarin Investigational Site
City
Johannesburg
ZIP/Postal Code
2113
Country
South Africa
Facility Name
Amarin Investigational Site
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Amarin Investigational Site
City
Pretoria
ZIP/Postal Code
157
Country
South Africa
Facility Name
Amarin Investigational Site
City
Somerset West
ZIP/Postal Code
7129
Country
South Africa
Facility Name
Amarin Investigational Site
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Amarin Investigational Site
City
Kiev
ZIP/Postal Code
3680
Country
Ukraine
Facility Name
Amarin Investigational Site
City
Kyiv
ZIP/Postal Code
4114
Country
Ukraine
Facility Name
Amarin Investigational Site
City
Odessa
ZIP/Postal Code
65059
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21683321
Citation
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.
Results Reference
result
PubMed Identifier
23312052
Citation
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.
Results Reference
result
PubMed Identifier
23325450
Citation
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.
Results Reference
result
PubMed Identifier
23992935
Citation
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.
Results Reference
result
PubMed Identifier
25893544
Citation
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.
Results Reference
result
PubMed Identifier
27206952
Citation
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.
Results Reference
result
PubMed Identifier
27596132
Citation
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.
Results Reference
result
PubMed Identifier
27418543
Citation
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.
Results Reference
result
PubMed Identifier
27939227
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs