Clinical trial NCT01047683: Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Amarin Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-13
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels
timeFrame: baseline and 12 weeks
measure: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels
timeFrame: baseline and 12 weeks
measure: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels
timeFrame: baseline and 12 weeks
Other outcomes:
measure: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels
timeFrame: baseline and 12 weeks
measure: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels
timeFrame: baseline and 12 weeks
Locations:
city: Sacramento
country: United States
facility: Amarin Investigational Site
state: California
city: Golden
country: United States
facility: Amarin Investigational Site
state: Colorado
city: Miami
country: United States
facility: Amarin Investigational Site
state: Florida
city: Miami
country: United States
facility: Amarin Investigational Site
state: Florida
city: Ocala
country: United States
facility: Amarin Investigational Site
state: Florida
city: Addison
country: United States
facility: Amarin Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Amarin Investigational Site
state: Illinois
city: Louisville
country: United States
facility: Amarin Investigational Site
state: Kentucky
city: Butte
country: United States
facility: Amarin Investigational Site
state: Montana
city: Raleigh
country: United States
facility: Amarin Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Amarin Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Amarin Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Amarin Investigational Site
state: Ohio
city: Lyndhurst
country: United States
facility: Amarin Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Amarin Investigational Site
state: Oklahoma
city: Corpus Christi
country: United States
facility: Amarin Investigational Site
state: Texas
city: Houston
country: United States
facility: Amarin Investigational Site
state: Texas
city: Richmond
country: United States
facility: Amarin Investigational Site
state: Virginia
city: Aalborg
country: Denmark
facility: Amarin Investigational Site
city: Herlev
country: Denmark
facility: Amarin Investigational Site
city: Oulu
country: Finland
facility: Amarin Investigational Site
city: Dresden
country: Germany
facility: Amarin Investigational Site
city: Giessen
country: Germany
facility: Amarin Investigational Site
city: Magdeburg
country: Germany
facility: Amarin Investigational Site
city: Muenchen
country: Germany
facility: Amarin Investigational Site
city: Muenchen
country: Germany
facility: Amarin Investigational Site
city: Nuernberg
country: Germany
facility: Amarin Investigational Site
city: Ahmedabad
country: India
facility: Amarin Investigational Site
city: Bangalore
country: India
facility: Amarin Investigational Site
city: Bangalore
country: India
facility: Amarin Investigational Site
city: Bangalore
country: India
facility: Amarin Investigational Site
city: Gopalapuram
country: India
facility: Amarin Investigational Site
city: Indore
country: India
facility: Amarin Investigational Site
city: Mysore
country: India
facility: Amarin Investigational Site
city: Genova
country: Italy
facility: Amarin Investigational Site
city: Palermo
country: Italy
facility: Amarin Investigational Site
city: Guadalajara, Jalisco
country: Mexico
facility: Amarin Investigational Site
city: Mexico City
country: Mexico
facility: Amarin Investigational Site
city: Mexico City
country: Mexico
facility: Amarin Investigational Site
city: Monterrey Nuevo Leon
country: Mexico
facility: Amarin Investigational Site
city: Amsterdam
country: Netherlands
facility: Amarin Investigational Site
city: Groningen
country: Netherlands
facility: Amarin Investigational Site
city: Rotterdam
country: Netherlands
facility: Amarin Investigational Site
city: Rotterdam
country: Netherlands
facility: Amarin Investigational Site
city: Utrecht
country: Netherlands
facility: Amarin Investigational Site
city: Moscow
country: Russian Federation
facility: Amarin Investigational Site
city: Moscow
country: Russian Federation
facility: Amarin Investigational Site
city: St Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Amarin Investigational Site
city: Bloemfontein
country: South Africa
facility: Amarin Investigational Site
city: Cape Town
country: South Africa
facility: Amarin Investigational Site
city: Johannesburg
country: South Africa
facility: Amarin Investigational Site
city: Parktown
country: South Africa
facility: Amarin Investigational Site
city: Pretoria
country: South Africa
facility: Amarin Investigational Site
city: Somerset West
country: South Africa
facility: Amarin Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Amarin Investigational Site
city: Kiev
country: Ukraine
facility: Amarin Investigational Site
city: Kyiv
country: Ukraine
facility: Amarin Investigational Site
city: Odessa
country: Ukraine
facility: Amarin Investigational Site
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.