HypertriglyceridemiaPhase 3MARINENCT01047683

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

A Phase 3 study testing AMR101 (ethyl icosapentate) - 4 g/day and AMR101 (ethyl icosapentate) - 2 g/day in people with Hypertriglyceridemia, run by Amarin Pharma Inc. at 60 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertriglyceridemia
What is being tested?: AMR101 (ethyl icosapentate) - 4 g/day and AMR101 (ethyl icosapentate) - 2 g/day
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 229 participants
Where: 60 sitesin 11 countries
Study dates: Dec 2009to Jul 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

60 sites in 11 countries.

Country

City, postcode or hospital

60 sites in 11 countries

United States18 sites

Amarin Investigational Site
Addison, Illinois, 27106
Amarin Investigational Site
Butte, Montana, 59701
Amarin Investigational Site
Chicago, Illinois, 60611
Amarin Investigational Site
Cincinnati, Ohio, 45212
Amarin Investigational Site
Cincinnati, Ohio, 45219
Amarin Investigational Site
Corpus Christi, Texas, 78404
Amarin Investigational Site
Golden, Colorado, 80401
Amarin Investigational Site
Houston, Texas, 77030
Amarin Investigational Site
Louisville, Kentucky, 40213
Amarin Investigational Site
Lyndhurst, Ohio, 44124
Amarin Investigational Site
Miami, Florida, 33169
Amarin Investigational Site
Miami, Florida, 33183
Amarin Investigational Site
Ocala, Florida, 34471
Amarin Investigational Site
Raleigh, North Carolina, 27527
Amarin Investigational Site
Richmond, Virginia, 23294
Amarin Investigational Site
Sacramento, California, 95823
Amarin Investigational Site
Tulsa, Oklahoma, 74136
Amarin Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

India7 sites

Amarin Investigational Site
Ahmedabad, 380 015
Amarin Investigational Site
Bangalore, 560003
Amarin Investigational Site
Bangalore, 560010
Amarin Investigational Site
Bangalore, 560054
Amarin Investigational Site
Gopālapuram, 600086
Amarin Investigational Site
Indore, 452010
Amarin Investigational Site
Mysore, 570 020

Other trials in India

Germany6 sites

Amarin Investigational Site
Dresden, 1307
Amarin Investigational Site
Giessen, 35392
Amarin Investigational Site
Magdeburg, 39120
Amarin Investigational Site
München, 80336
Amarin Investigational Site
München, 81377
Amarin Investigational Site
Nuremberg, 90402

Other trials in Germany

South Africa6 sites

Amarin Investigational Site
Bloemfontein, 9301
Amarin Investigational Site
Cape Town, 7500
Amarin Investigational Site
Johannesburg, 2113
Amarin Investigational Site
Parktown, 2193
Amarin Investigational Site
Pretoria, 157
Amarin Investigational Site
Somerset West, 7129

Other trials in South Africa

Netherlands5 sites

Amarin Investigational Site
Amsterdam, 1105 AZ
Amarin Investigational Site
Groningen, 9711 SG
Amarin Investigational Site
Rotterdam, 3021 HC
Amarin Investigational Site
Rotterdam, 3045 PM
Amarin Investigational Site
Utrecht, 3584 CX

Other trials in Netherlands

Russia5 sites

Amarin Investigational Site
Moscow, 121552
Amarin Investigational Site
Moscow, 129090
Amarin Investigational Site
Saint Petersburg, 194291
Amarin Investigational Site
Saint Petersburg, 197341
Amarin Investigational Site
Saint Petersburg, 198205

Other trials in Russia

Mexico4 sites

Amarin Investigational Site
Guadalajara, Jalisco, 44600
Amarin Investigational Site
Mexico City, 11650
Amarin Investigational Site
Mexico City, 6700
Amarin Investigational Site
Monterrey Nuevo Leon, 64460

Other trials in Mexico

Ukraine4 sites

Amarin Investigational Site
Ivano-Frankivsk, 76018
Amarin Investigational Site
Kiev, 3680
Amarin Investigational Site
Kyiv, 4114
Amarin Investigational Site
Odesa, 65059

Other trials in Ukraine

Denmark2 sites

Amarin Investigational Site
Aalborg, 9000
Amarin Investigational Site
Herlev, 2730

Other trials in Denmark

Italy2 sites

Amarin Investigational Site
Genova, I-16132
Amarin Investigational Site
Palermo, 90127

Other trials in Italy

Finland1 site

Amarin Investigational Site
Oulu, FI-90014

Other trials in Finland

About this study

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

Conditions: Hypertriglyceridemia
Being tested: AMR101 (ethyl icosapentate) - 4 g/day, AMR101 (ethyl icosapentate) - 2 g/day, Placebo
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
Medical subject headings: Hypertriglyceridemia, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AMR101 (ethyl icosapentate) - 4 g/dayDrug
Also called VASCEPA® (icosapent ethyl)
AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)
AMR101 (ethyl icosapentate) - 2 g/dayDrug
Also called VASCEPA® (icosapent ethyl)
AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)
PlaceboDrug
Placebo 4 capsules/day for 12 weeks (Weeks 1-12)

Study groups in NCT01047683
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
AMR101 (ethyl icosapentate) - 2 g/day	Experimental	Not described Receives: Drug: AMR101 (ethyl icosapentate) - 2 g/day
AMR101 (ethyl icosapentate) - 4 g/day	Experimental	Not described Receives: Drug: AMR101 (ethyl icosapentate) - 4 g/day

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: baseline and 12 weeks

Secondary outcomes (3)

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
Measured: baseline and 12 weeks
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
Measured: 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
Measured: baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Jul 2011

First posted13 Jan 2010 (estimated)
Study startDec 2009
Primary completionOct 2010
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 229 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01047683
Sponsor's protocol ID: AMR-01-01-0016
Other IDs: The MARINE Study
Acronym: MARINE
Status last verified: Mar 2022
First submitted: 11 Jan 2010
Last updated: 25 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 21683321
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.
PubMed 23312052
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.
PubMed 23325450
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.
PubMed 23992935
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.
PubMed 25893544
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.
PubMed 27206952
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.
PubMed 27596132
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.
PubMed 27418543
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.
PubMed 27939227

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia

All Hypertriglyceridemia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01047683
Acronym / sponsor ID: MARINE / AMR-01-01-0016
Conditions: Hypertriglyceridemia
Keywords: hypertriglyceridemia, omega-3 fatty acids, statin, triglycerides, lipids, EPA, docosahexaenoic acid, fish
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 229 participants (actual)
Lead sponsor: Amarin Pharma Inc.Industry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Oct 2010 (actual)
Study completion: Jul 2011 (actual)
First posted: 13 Jan 2010 (estimated)
Results: Posted 25 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
AMR101 (ethyl icosapentate) - 2 g/day	Experimental	Drug: AMR101 (ethyl icosapentate) - 2 g/day
AMR101 (ethyl icosapentate) - 4 g/day	Experimental	Drug: AMR101 (ethyl icosapentate) - 4 g/day

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (10 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AMR101 (ethyl icosapentate) - 4 g/dayAlso: VASCEPA® (icosapent ethyl)AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)	Drug	AMR101 (ethyl icosapentate) - 4 g/day
AMR101 (ethyl icosapentate) - 2 g/dayAlso: VASCEPA® (icosapent ethyl)AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)	Drug	AMR101 (ethyl icosapentate) - 2 g/day
PlaceboPlacebo 4 capsules/day for 12 weeks (Weeks 1-12)	Drug	Placebo

Primary outcome

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect
Time frame: baseline and 12 weeks
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

3 secondary outcomes

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels
Time frame: baseline and 12 weeks
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels
Time frame: baseline and 12 weeks
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels
Time frame: baseline and 12 weeks

Results and safety

Results posted to the registry on 25 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	76	71
AMR101 (Ethyl Icosapentate) - 2 g/Day	76	70
AMR101 (Ethyl Icosapentate) - 4 g/Day	77	74

Primary outcome: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect

Time frame: baseline and 12 weeks. Median (Inter-Quartile Range). Unit: Percent change from baseline

Measure	AMR101 (Ethyl Icosapentate) - 2 g/Day n = 73	AMR101 (Ethyl Icosapentate) - 4 g/Day n = 76	Placebo n = 75
Value	-7.0 (-30.1 to 18.6)	-26.6 (-41.1 to 0.0)	9.7 (-19.2 to 42.3)

AMR101 (Ethyl Icosapentate) - 4 g/Day vs Placebo: Median Difference (Final Values): -33.1 (95% CI -46.6 to -21.5), p <0.0001, Wilcoxon rank-sum test
AMR101 (Ethyl Icosapentate) - 2 g/Day vs Placebo: Median Difference (Final Values): -19.7 (95% CI -33.3 to -5.6), p = 0.0051, Wilcoxon rank-sum test

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 76 (0%)	12 of 76 (15.8%)	Not reported
AMR101 (Ethyl Icosapentate) - 2 g/Day	1 of 76 (1.3%)	10 of 76 (13.2%)	Not reported
AMR101 (Ethyl Icosapentate) - 4 g/Day	1 of 77 (1.3%)	2 of 77 (2.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21683321Bays 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 publication: PubMed 23312052Bays 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 publication: PubMed 23325450Bays 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 publication: PubMed 23992935Braeckman 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 publication: PubMed 25893544Bays 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 publication: PubMed 27206952Ballantyne 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 publication: PubMed 27596132Ballantyne 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 publication: PubMed 27418543Bays 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 publication: PubMed 27939227Mosca 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.
Individual participant dataSharing planned: No

Related trials for Hypertriglyceridemia

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

60 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AMR101 (ethyl icosapentate) - 4 g/day and AMR101 (ethyl icosapentate) - 2 g/day in people with Hypertriglyceridemia, run by Amarin Pharma Inc. at 60 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, India, Germany, South Africa, Netherlands and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01047683, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.