Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| The MARINE Study | Other Identifier | Amarin Pharma Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| AMR101 (ethyl icosapentate) - 2 g/day | Experimental |
| |
| AMR101 (ethyl icosapentate) - 4 g/day | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMR101 (ethyl icosapentate) - 4 g/day | Drug | AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels | 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 | baseline and 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amarin Investigational Site | Sacramento | California | 95823 | United States | ||
| Amarin Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21683321 | Result | 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. | |
| 23312052 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Placebo 4 capsules/day for 12 weeks (Weeks 1-12) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AMR101 (ethyl icosapentate) - 2 g/day | Drug | AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12) |
|
|
| Placebo | Drug | Placebo 4 capsules/day for 12 weeks (Weeks 1-12) |
|
| 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 |
| baseline and 12 weeks |
| 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 | baseline and 12 weeks |
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels |
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 |
| baseline and 12 weeks |
| Golden |
| Colorado |
| 80401 |
| United States |
| Amarin Investigational Site | Miami | Florida | 33169 | United States |
| Amarin Investigational Site | Miami | Florida | 33183 | United States |
| Amarin Investigational Site | Ocala | Florida | 34471 | United States |
| Amarin Investigational Site | Addison | Illinois | 27106 | United States |
| Amarin Investigational Site | Chicago | Illinois | 60611 | United States |
| Amarin Investigational Site | Louisville | Kentucky | 40213 | United States |
| Amarin Investigational Site | Butte | Montana | 59701 | United States |
| Amarin Investigational Site | Raleigh | North Carolina | 27527 | United States |
| Amarin Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Amarin Investigational Site | Cincinnati | Ohio | 45212 | United States |
| Amarin Investigational Site | Cincinnati | Ohio | 45219 | United States |
| Amarin Investigational Site | Lyndhurst | Ohio | 44124 | United States |
| Amarin Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| Amarin Investigational Site | Corpus Christi | Texas | 78404 | United States |
| Amarin Investigational Site | Houston | Texas | 77030 | United States |
| Amarin Investigational Site | Richmond | Virginia | 23294 | United States |
| Amarin Investigational Site | Aalborg | 9000 | Denmark |
| Amarin Investigational Site | Herlev | 2730 | Denmark |
| Amarin Investigational Site | Oulu | FI-90014 | Finland |
| Amarin Investigational Site | Dresden | 1307 | Germany |
| Amarin Investigational Site | Giessen | 35392 | Germany |
| Amarin Investigational Site | Magdeburg | 39120 | Germany |
| Amarin Investigational Site | München | 80336 | Germany |
| Amarin Investigational Site | München | 81377 | Germany |
| Amarin Investigational Site | Nuremberg | 90402 | Germany |
| Amarin Investigational Site | Ahmedabad | 380 015 | India |
| Amarin Investigational Site | Bangalore | 560003 | India |
| Amarin Investigational Site | Bangalore | 560010 | India |
| Amarin Investigational Site | Bangalore | 560054 | India |
| Amarin Investigational Site | Gopālapuram | 600086 | India |
| Amarin Investigational Site | Indore | 452010 | India |
| Amarin Investigational Site | Mysore | 570 020 | India |
| Amarin Investigational Site | Genova | I-16132 | Italy |
| Amarin Investigational Site | Palermo | 90127 | Italy |
| Amarin Investigational Site | Guadalajara, Jalisco | 44600 | Mexico |
| Amarin Investigational Site | Mexico City | 11650 | Mexico |
| Amarin Investigational Site | Mexico City | 6700 | Mexico |
| Amarin Investigational Site | Monterrey Nuevo Leon | 64460 | Mexico |
| Amarin Investigational Site | Amsterdam | 1105 AZ | Netherlands |
| Amarin Investigational Site | Groningen | 9711 SG | Netherlands |
| Amarin Investigational Site | Rotterdam | 3021 HC | Netherlands |
| Amarin Investigational Site | Rotterdam | 3045 PM | Netherlands |
| Amarin Investigational Site | Utrecht | 3584 CX | Netherlands |
| Amarin Investigational Site | Moscow | 121552 | Russia |
| Amarin Investigational Site | Moscow | 129090 | Russia |
| Amarin Investigational Site | Saint Petersburg | 194291 | Russia |
| Amarin Investigational Site | Saint Petersburg | 197341 | Russia |
| Amarin Investigational Site | Saint Petersburg | 198205 | Russia |
| Amarin Investigational Site | Bloemfontein | 9301 | South Africa |
| Amarin Investigational Site | Cape Town | 7500 | South Africa |
| Amarin Investigational Site | Johannesburg | 2113 | South Africa |
| Amarin Investigational Site | Parktown | 2193 | South Africa |
| Amarin Investigational Site | Pretoria | 157 | South Africa |
| Amarin Investigational Site | Somerset West | 7129 | South Africa |
| Amarin Investigational Site | Ivano-Frankivsk | 76018 | Ukraine |
| Amarin Investigational Site | Kiev | 3680 | Ukraine |
| Amarin Investigational Site | Kyiv | 4114 | Ukraine |
| Amarin Investigational Site | Odesa | 65059 | Ukraine |
| Result |
| 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. |
| 23325450 | Result | 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. |
| 23992935 | Result | 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. |
| 25893544 | Result | 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. |
| 27206952 | Result | 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. |
| 27596132 | Result | 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. |
| 27418543 | Result | 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. |
| 27939227 | Result | 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. |
| FG002 | AMR101 (Ethyl Icosapentate) - 4 g/Day | AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Placebo 4 capsules/day for 12 weeks (Weeks 1-12) |
| BG001 | 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) |
| BG002 | AMR101 (Ethyl Icosapentate) - 4 g/Day | AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Intent-to-treat population: randomized patients who received >= 1 dose of study drug and had baseline and >= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included. | Posted | Median | Inter-Quartile Range | Percent change from baseline | baseline and 12 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Intent-to-treat population: randomized patients who received >= 1 dose of study drug and had baseline and >= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included. | Posted | Median | Inter-Quartile Range | Percent change from baseline | baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Intent-to-treat population: randomized patients who received >= 1 dose of study drug and had baseline and >= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included. | Posted | Median | Inter-Quartile Range | Percent change from baseline | baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Intent-to-treat population: randomized patients who received >= 1 dose of study drug and had baseline and >= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included. | Posted | Median | Inter-Quartile Range | Percent change from baseline | baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels | 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 | Intent-to-treat population: randomized patients who received >= 1 dose of study drug and had baseline and >= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included. | Posted | Median | Inter-Quartile Range | Percent change from baseline | baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels | 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 | Intent-to-treat population: randomized patients who received >= 1 dose of study drug and had baseline and >= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included. | Posted | Median | Inter-Quartile Range | Percent change from baseline | baseline and 12 weeks |
|
12 weeks
Events were collected by systematic assessment at each study visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: Placebo 4 capsules/day for 12 weeks (Weeks 1-12) | 0 | 76 | 12 | 76 | ||
| EG001 | 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) | 1 | 76 | 10 | 76 | ||
| EG002 | AMR101 (Ethyl Icosapentate) - 4 g/Day | AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12) | 1 | 77 | 2 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
PIs are restricted in sharing data until an abstract presentation or publication of the manuscript.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alex Giaquinto | Amarin Pharma, Inc. | +1 908 326 1324 | alex.giaquinto@amarincorp.com |
| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C035276 | eicosapentaenoic acid ethyl ester |
| C509895 | eicosapentaenoic acid ethanolamide |
Not provided
Not provided
Not provided
| Male |
|
| Other |
|
Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method. |
| Superiority or Other (legacy) |
| Wilcoxon rank-sum test | 0.0051 | Median Difference (Final Values) | -19.7 | 2-Sided | 95 | -33.3 | -5.6 | Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method. | Superiority or Other (legacy) |
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|