Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)

NCT01047501 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: AMR-01-01-0017The ANCHOR Study
• Study Type: interventional
• Target: 702
• Locations: 1 country
• Sites: 80

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels

  baseline and 12 weeks

• Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels

  baseline and 12 weeks

• Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels

  baseline and 12 weeks

• Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels

  baseline and 12 weeks

• Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels

  baseline and 12 weeks

Study Arms (3)

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

Interventions

AMR101 (ethyl icosapentate) - 4 g/day DRUG

AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks

Also known as: VASCEPA® (icosapent ethyl)

AMR101 (ethyl icosapentate) - 4 g/day

AMR101 (ethyl icosapentate) - 2 g/day DRUG

AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks

Also known as: VASCEPA® (icosapent ethyl)

AMR101 (ethyl icosapentate) - 2 g/day

Placebo DRUG

Placebo 4 capsules/day for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amarin Pharma Inc.: lead

Study Sites (80)

Amarin Investigational Site

Muscle Shoals, Alabama, 35662, United States

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Amarin Investigational Site

Scottsboro, Alabama, 35768, United States

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Amarin Investigational Site

Phoenix, Arizona, 85050, United States

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Amarin Investigational Site

Tucson, Arizona, 85705, United States

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Amarin Investigational Site

Anaheim, California, 92801, United States

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Amarin Investigational Site

Burbank, California, 91505, United States

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Amarin Investigational Site

Chino, California, 91710, United States

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Amarin Investigational Site

Encinitas, California, 92024, United States

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Amarin Investigational Site

Irvine, California, 92618, United States

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Amarin Investigational Site

Los Angeles, California, 90025, United States

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Amarin Investigational Site

Los Angeles, California, 90057, United States

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Amarin Investigational Site

Spring Valley, California, 91978, United States

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Amarin Investigational Site

Westlake Village, California, 91361, United States

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Amarin Investigational Site

Golden, Colorado, 80401, United States

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Amarin Investigational Site

Wheat Ridge, Colorado, 80033, United States

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Amarin Investigational Site

Aventura, Florida, 33180, United States

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Amarin Investigational Site

Clearwater, Florida, 33756, United States

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Amarin Investigational Site

Coral Gables, Florida, 33134, United States

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Amarin Investigational Site

Hialeah, Florida, 33012, United States

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Amarin Investigational Site

Jacksonville, Florida, 32205, United States

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Amarin Investigational Site

Jacksonville, Florida, 32223, United States

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Amarin Investigational Site

Miami, Florida, 33169, United States

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Amarin Investigational Site

New Port Richey, Florida, 34652, United States

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Amarin Investigational Site

New Port Richey, Florida, 34653, United States

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Amarin Investigational Site

Orlando, Florida, 32833, United States

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Amarin Investigational Site

Port Orange, Florida, 32127, United States

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Amarin Investigational Site

West Palm Beach, Florida, 33401, United States

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Amarin Investigational Site

Augusta, Georgia, 30904, United States

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Amarin Investigational Site

Augusta, Georgia, 30909, United States

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Amarin Investigational Site

Addison, Illinois, 60101, United States

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Amarin Investigational Site

Morton, Illinois, 61550, United States

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Amarin Investigational Site

Indianapolis, Indiana, 46260, United States

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Amarin Investigational Site

Kansas City, Kansas, 66160, United States

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Amarin Investigational Site

Newton, Kansas, 67114, United States

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Amarin Investigational Site

Wichita, Kansas, 67205, United States

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Amarin Investigational Site

Louisville, Kentucky, 40213, United States

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Amarin Investigational Site

Munfordville, Kentucky, 42765, United States

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Amarin Investigational Site

Auburn, Maine, 04210, United States

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Amarin Investigational Site

Baltimore, Maryland, 21209, United States

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Amarin Investigational Site

Elkridge, Maryland, 21075, United States

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Amarin Investigational Site

Troy, Michigan, 48098, United States

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Amarin Investigational Site

Olive Branch, Mississippi, 38654, United States

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Amarin Investigational Site

St Louis, Missouri, 63110, United States

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Amarin Investigational Site

Butte, Montana, 59701, United States

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Amarin Investigational Site

Concord, New Hampshire, 03301, United States

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Amarin Investigational Site

Endwell, New York, 13760, United States

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Amarin Investigational Site

New Windsor, New York, 12553, United States

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Amarin Investigational Site

Syracuse, New York, 13202, United States

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Amarin Investigational Site

Charlotte, North Carolina, 28277, United States

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Amarin Investigational Site

Durham, North Carolina, 27710, United States

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Amarin Investigational Site

Hickory, North Carolina, 28601, United States

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Amarin Investigational Site

Raleigh, North Carolina, 27527, United States

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Amarin Investigational Site

Statesville, North Carolina, 28677, United States

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Amarin Investigational Site

Wilmington, North Carolina, 28401, United States

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Amarin Investigational Site

Winston-Salem, North Carolina, 27103, United States

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Amarin Investigational Site

Cincinnati, Ohio, 45212, United States

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Amarin Investigational Site

Cincinnati, Ohio, 45219, United States

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Amarin Investigational Site

Cleveland, Ohio, 44122, United States

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Amarin Investigational Site

Kettering, Ohio, 45429, United States

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Amarin Investigational Site

Norman, Oklahoma, 73069, United States

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Amarin Investigational Site

Tulsa, Oklahoma, 74136, United States

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Amarin Investigational Site

Beaver, Pennsylvania, 15009, United States

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Amarin Investigational Site

Harleysville, Pennsylvania, 19438, United States

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Amarin Investigational Site

Jersey Shore, Pennsylvania, 17740, United States

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Amarin Investigational Site

Lansdale, Pennsylvania, 19446, United States

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Amarin Investigational Site

Philadelphia, Pennsylvania, 19114, United States

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Amarin Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

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Amarin Investigational Site

Rapid City, South Dakota, 57702, United States

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Amarin Investigational Site

Dallas, Texas, 75230, United States

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Amarin Investigational Site

Houston, Texas, 77030, United States

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Amarin Investigational Site

Houston, Texas, 77074, United States

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Amarin Investigational Site

Lake Jackson, Texas, 77566, United States

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Amarin Investigational Site

San Antonio, Texas, 78224, United States

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Amarin Investigational Site

San Antonio, Texas, 78229, United States

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Amarin Investigational Site

Temple, Texas, 76502, United States

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Amarin Investigational Site

Ettrick, Virginia, 23803, United States

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Amarin Investigational Site

Norfolk, Virginia, 23502, United States

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Amarin Investigational Site

Richmond, Virginia, 23225, United States

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Amarin Investigational Site

Richmond, Virginia, 23294, United States

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Amarin Investigational Site

Wauwatosa, Wisconsin, 53226, United States

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Related Publications (13)

• 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.

  PMID: 22819432 RESULT

• 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.

  PMID: 23835245 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.

  PMID: 23325450 RESULT

• 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.

  PMID: 26073397 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.

  PMID: 25893544 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.

  PMID: 27206952 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.

  PMID: 27596132 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.

  PMID: 27418543 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.

  PMID: 27939227 RESULT

• 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.

  PMID: 29583081 RESULT

• 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.

  PMID: 31277790 RESULT

• 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.

  PMID: 30788718 RESULT

• 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.

  PMID: 31306043 RESULT

MeSH Terms

Conditions

Hypertriglyceridemia; Dyslipidemias

Interventions

eicosapentaenoic acid ethyl ester; eicosapentaenoic acid ethanolamide

Condition Hierarchy (Ancestors)

Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Alex Giaquinto
• Organization: Amarin Pharma, Inc.

alex.giaquinto@amarincorp.com

+1 908 326 1324

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 13, 2010
• Study Start: December 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 25, 2022
• Results First Posted: April 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (80)