Clinical trial NCT01047501: Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)
Official title: Evaluation of the Effect of Two Doses of AMR101 (Ethyl Icosapentate) on Fasting Serum Triglyceride Levels in Patients With Persistent High Triglyceride Levels (≥ 200 mg/dL and < 500 mg/dL) Despite Statin Therapy
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
Niaspan
ezetimibe
Zetia
ethyl-EPA
ethyl icosapentate
Crestor
Zocor
Lipitor
LDL
HDL
cholesterol
dyslipidemia
VASCEPA
icosapent ethyl
Lead sponsor: Amarin Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-13
Enrollment: 702
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 high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and \< 500 mg/dL.


Eligibility criteria: Inclusion Criteria:

* Men and women, ages \>18
* Fasting triglyceride ≥200 mg/dL and \<500 mg/dL
* LDL-C (low density lipoprotein - cholesterol) ≥40 mg/dL and \<100 mg/dL
* High risk for coronary heart disease
* On stable dose of statin (atorvastatin, rosuvastatin or simvastatin)
* 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 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 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
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 Groups in Apolipoprotein B Levels
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Amarin Investigational Site
state: Alabama
city: Scottsboro
country: United States
facility: Amarin Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Amarin Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Amarin Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: Amarin Investigational Site
state: California
city: Burbank
country: United States
facility: Amarin Investigational Site
state: California
city: Chino
country: United States
facility: Amarin Investigational Site
state: California
city: Encinitas
country: United States
facility: Amarin Investigational Site
state: California
city: Irvine
country: United States
facility: Amarin Investigational Site
state: California
city: Los Angeles
country: United States
facility: Amarin Investigational Site
state: California
city: Los Angeles
country: United States
facility: Amarin Investigational Site
state: California
city: Spring Valley
country: United States
facility: Amarin Investigational Site
state: California
city: Westlake Village
country: United States
facility: Amarin Investigational Site
state: California
city: Golden
country: United States
facility: Amarin Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Amarin Investigational Site
state: Colorado
city: Aventura
country: United States
facility: Amarin Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Amarin Investigational Site
state: Florida
city: Coral Gables
country: United States
facility: Amarin Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Amarin Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Amarin Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Amarin Investigational Site
state: Florida
city: Miami
country: United States
facility: Amarin Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Amarin Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Amarin Investigational Site
state: Florida
city: Orlando
country: United States
facility: Amarin Investigational Site
state: Florida
city: Port Orange
country: United States
facility: Amarin Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Amarin Investigational Site
state: Florida
city: Augusta
country: United States
facility: Amarin Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Amarin Investigational Site
state: Georgia
city: Addison
country: United States
facility: Amarin Investigational Site
state: Illinois
city: Morton
country: United States
facility: Amarin Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Amarin Investigational Site
state: Indiana
city: Kansas City
country: United States
facility: Amarin Investigational Site
state: Kansas
city: Newton
country: United States
facility: Amarin Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Amarin Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Amarin Investigational Site
state: Kentucky
city: Munfordville
country: United States
facility: Amarin Investigational Site
state: Kentucky
city: Auburn
country: United States
facility: Amarin Investigational Site
state: Maine
city: Baltimore
country: United States
facility: Amarin Investigational Site
state: Maryland
city: Elkridge
country: United States
facility: Amarin Investigational Site
state: Maryland
city: Troy
country: United States
facility: Amarin Investigational Site
state: Michigan
city: Olive Branch
country: United States
facility: Amarin Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: Amarin Investigational Site
state: Missouri
city: Butte
country: United States
facility: Amarin Investigational Site
state: Montana
city: Concord
country: United States
facility: Amarin Investigational Site
state: New Hampshire
city: Endwell
country: United States
facility: Amarin Investigational Site
state: New York
city: New Windsor
country: United States
facility: Amarin Investigational Site
state: New York
city: Syracuse
country: United States
facility: Amarin Investigational Site
state: New York
city: Charlotte
country: United States
facility: Amarin Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Amarin Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Amarin Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Amarin Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: Amarin Investigational Site
state: North Carolina
city: Wilmington
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: Cleveland
country: United States
facility: Amarin Investigational Site
state: Ohio
city: Kettering
country: United States
facility: Amarin Investigational Site
state: Ohio
city: Norman
country: United States
facility: Amarin Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Amarin Investigational Site
state: Oklahoma
city: Beaver
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Harleysville
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Jersey Shore
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Lansdale
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Amarin Investigational Site
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Amarin Investigational Site
state: South Carolina
city: Rapid City
country: United States
facility: Amarin Investigational Site
state: South Dakota
city: Dallas
country: United States
facility: Amarin Investigational Site
state: Texas
city: Houston
country: United States
facility: Amarin Investigational Site
state: Texas
city: Houston
country: United States
facility: Amarin Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: Amarin Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Amarin Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Amarin Investigational Site
state: Texas
city: Temple
country: United States
facility: Amarin Investigational Site
state: Texas
city: Ettrick
country: United States
facility: Amarin Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Amarin Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Amarin Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Amarin Investigational Site
state: Virginia
city: Wauwatosa
country: United States
facility: Amarin Investigational Site
state: Wisconsin
Study officials:
References:
citation: Ballantyne CM, Bays HE, Kastelein JJ, Stein E, Isaacsohn JL, Braeckman RA, Soni PN. Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study). Am J Cardiol. 2012 Oct 1;110(7):984-92. doi: 10.1016/j.amjcard.2012.05.031. Epub 2012 Jul 20.
citation: Brinton EA, Ballantyne CM, Bays HE, Kastelein JJ, Braeckman RA, Soni PN. Effects of icosapent ethyl on lipid and inflammatory parameters in patients with diabetes mellitus-2, residual elevated triglycerides (200-500 mg/dL), and on statin therapy at LDL-C goal: the ANCHOR study. Cardiovasc Diabetol. 2013 Jul 9;12:100. doi: 10.1186/1475-2840-12-100.
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: Ballantyne CM, Braeckman RA, Bays HE, Kastelein JJ, Otvos JD, Stirtan WG, Doyle RT Jr, Soni PN, Juliano RA. Effects of icosapent ethyl on lipoprotein particle concentration and size in statin-treated patients with persistent high triglycerides (the ANCHOR Study). J Clin Lipidol. 2015 May-Jun;9(3):377-83. doi: 10.1016/j.jacl.2014.11.009. Epub 2014 Nov 29.
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.
citation: Brinton EA, Ballantyne CM, Guyton JR, Philip S, Doyle RT Jr, Juliano RA, Mosca L. Lipid Effects of Icosapent Ethyl in Women with Diabetes Mellitus and Persistent High Triglycerides on Statin Treatment: ANCHOR Trial Subanalysis. J Womens Health (Larchmt). 2018 Sep;27(9):1170-1176. doi: 10.1089/jwh.2017.6757. Epub 2018 Mar 27.
citation: Miller M, Ballantyne CM, Bays HE, Granowitz C, Doyle RT Jr, Juliano RA, Philip S. Effects of Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) on Atherogenic Lipid/Lipoprotein, Apolipoprotein, and Inflammatory Parameters in Patients With Elevated High-Sensitivity C-Reactive Protein (from the ANCHOR Study). Am J Cardiol. 2019 Sep 1;124(5):696-701. doi: 10.1016/j.amjcard.2019.05.057. Epub 2019 Jun 6.
citation: Ballantyne CM, Manku MS, Bays HE, Philip S, Granowitz C, Doyle RT Jr, Juliano RA. Icosapent Ethyl Effects on Fatty Acid Profiles in Statin-Treated Patients With High Triglycerides: The Randomized, Placebo-controlled ANCHOR Study. Cardiol Ther. 2019 Jun;8(1):79-90. doi: 10.1007/s40119-019-0131-8. Epub 2019 Feb 20.
citation: Vijayaraghavan K, Szerlip HM, Ballantyne CM, Bays HE, Philip S, Doyle RT Jr, Juliano RA, Granowitz C. Icosapent ethyl reduces atherogenic markers in high-risk statin-treated patients with stage 3 chronic kidney disease and high triglycerides. Postgrad Med. 2019 Aug;131(6):390-396. doi: 10.1080/00325481.2019.1643633. Epub 2019 Jul 25.