- ICH GCP
- US Clinical Trials Registry
- 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) (ANCHOR)
March 28, 2022 updated by: Amarin Pharma Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
702
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Muscle Shoals, Alabama, United States, 35662
- Amarin Investigational Site
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Scottsboro, Alabama, United States, 35768
- Amarin Investigational Site
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Arizona
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Phoenix, Arizona, United States, 85050
- Amarin Investigational Site
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Tucson, Arizona, United States, 85705
- Amarin Investigational Site
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California
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Anaheim, California, United States, 92801
- Amarin Investigational Site
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Burbank, California, United States, 91505
- Amarin Investigational Site
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Chino, California, United States, 91710
- Amarin Investigational Site
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Encinitas, California, United States, 92024
- Amarin Investigational Site
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Irvine, California, United States, 92618
- Amarin Investigational Site
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Los Angeles, California, United States, 90025
- Amarin Investigational Site
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Los Angeles, California, United States, 90057
- Amarin Investigational Site
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Spring Valley, California, United States, 91978
- Amarin Investigational Site
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Westlake Village, California, United States, 91361
- Amarin Investigational Site
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Colorado
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Golden, Colorado, United States, 80401
- Amarin Investigational Site
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Wheat Ridge, Colorado, United States, 80033
- Amarin Investigational Site
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Florida
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Aventura, Florida, United States, 33180
- Amarin Investigational Site
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Clearwater, Florida, United States, 33756
- Amarin Investigational Site
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Coral Gables, Florida, United States, 33134
- Amarin Investigational Site
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Hialeah, Florida, United States, 33012
- Amarin Investigational Site
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Jacksonville, Florida, United States, 32205
- Amarin Investigational Site
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Jacksonville, Florida, United States, 32223
- Amarin Investigational Site
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Miami, Florida, United States, 33169
- Amarin Investigational Site
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New Port Richey, Florida, United States, 34652
- Amarin Investigational Site
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New Port Richey, Florida, United States, 34653
- Amarin Investigational Site
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Orlando, Florida, United States, 32833
- Amarin Investigational Site
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Port Orange, Florida, United States, 32127
- Amarin Investigational Site
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West Palm Beach, Florida, United States, 33401
- Amarin Investigational Site
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Georgia
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Augusta, Georgia, United States, 30904
- Amarin Investigational Site
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Augusta, Georgia, United States, 30909
- Amarin Investigational Site
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Illinois
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Addison, Illinois, United States, 60101
- Amarin Investigational Site
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Morton, Illinois, United States, 61550
- Amarin Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46260
- Amarin Investigational Site
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Kansas
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Kansas City, Kansas, United States, 66160
- Amarin Investigational Site
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Newton, Kansas, United States, 67114
- Amarin Investigational Site
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Wichita, Kansas, United States, 67205
- Amarin Investigational Site
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Kentucky
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Louisville, Kentucky, United States, 40213
- Amarin Investigational Site
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Munfordville, Kentucky, United States, 42765
- Amarin Investigational Site
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Maine
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Auburn, Maine, United States, 04210
- Amarin Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21209
- Amarin Investigational Site
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Elkridge, Maryland, United States, 21075
- Amarin Investigational Site
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Michigan
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Troy, Michigan, United States, 48098
- Amarin Investigational Site
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Mississippi
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Olive Branch, Mississippi, United States, 38654
- Amarin Investigational Site
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Missouri
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Saint Louis, Missouri, United States, 63110
- Amarin Investigational Site
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Montana
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Butte, Montana, United States, 59701
- Amarin Investigational Site
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New Hampshire
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Concord, New Hampshire, United States, 03301
- Amarin Investigational Site
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New York
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Endwell, New York, United States, 13760
- Amarin Investigational Site
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New Windsor, New York, United States, 12553
- Amarin Investigational Site
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Syracuse, New York, United States, 13202
- Amarin Investigational Site
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North Carolina
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Charlotte, North Carolina, United States, 28277
- Amarin Investigational Site
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Durham, North Carolina, United States, 27710
- Amarin Investigational Site
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Hickory, North Carolina, United States, 28601
- Amarin Investigational Site
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Raleigh, North Carolina, United States, 27527
- Amarin Investigational Site
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Statesville, North Carolina, United States, 28677
- Amarin Investigational Site
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Wilmington, North Carolina, United States, 28401
- Amarin Investigational Site
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Winston-Salem, North Carolina, United States, 27103
- Amarin Investigational Site
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Ohio
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Cincinnati, Ohio, United States, 45212
- Amarin Investigational Site
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Cincinnati, Ohio, United States, 45219
- Amarin Investigational Site
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Cleveland, Ohio, United States, 44122
- Amarin Investigational Site
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Kettering, Ohio, United States, 45429
- Amarin Investigational Site
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Oklahoma
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Norman, Oklahoma, United States, 73069
- Amarin Investigational Site
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Tulsa, Oklahoma, United States, 74136
- Amarin Investigational Site
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Pennsylvania
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Beaver, Pennsylvania, United States, 15009
- Amarin Investigational Site
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Harleysville, Pennsylvania, United States, 19438
- Amarin Investigational Site
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Jersey Shore, Pennsylvania, United States, 17740
- Amarin Investigational Site
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Lansdale, Pennsylvania, United States, 19446
- Amarin Investigational Site
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Philadelphia, Pennsylvania, United States, 19114
- Amarin Investigational Site
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South Carolina
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Mount Pleasant, South Carolina, United States, 29464
- Amarin Investigational Site
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South Dakota
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Rapid City, South Dakota, United States, 57702
- Amarin Investigational Site
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Texas
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Dallas, Texas, United States, 75230
- Amarin Investigational Site
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Houston, Texas, United States, 77030
- Amarin Investigational Site
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Houston, Texas, United States, 77074
- Amarin Investigational Site
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Lake Jackson, Texas, United States, 77566
- Amarin Investigational Site
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San Antonio, Texas, United States, 78224
- Amarin Investigational Site
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San Antonio, Texas, United States, 78229
- Amarin Investigational Site
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Temple, Texas, United States, 76502
- Amarin Investigational Site
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Virginia
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Ettrick, Virginia, United States, 23803
- Amarin Investigational Site
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Norfolk, Virginia, United States, 23502
- Amarin Investigational Site
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Richmond, Virginia, United States, 23225
- Amarin Investigational Site
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Richmond, Virginia, United States, 23294
- Amarin Investigational Site
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Wisconsin
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Wauwatosa, Wisconsin, United States, 53226
- Amarin Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Placebo 4 capsules/day for 12 weeks
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Experimental: AMR101 (ethyl icosapentate) - 2 g/day
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AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
Other Names:
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Experimental: AMR101 (ethyl icosapentate) - 4 g/day
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AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect
Time Frame: baseline and 12 weeks
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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
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baseline and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels
Time Frame: baseline and 12 weeks
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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
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baseline and 12 weeks
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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels
Time Frame: baseline and 12 weeks
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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
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baseline and 12 weeks
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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels
Time Frame: baseline and 12 weeks
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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
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baseline and 12 weeks
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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels
Time Frame: baseline and 12 weeks
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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
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baseline and 12 weeks
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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels
Time Frame: baseline and 12 weeks
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Median 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
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baseline and 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Erratum In: Cardiovasc Diabetol. 2015 Jul-Aug;9(4):618.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
January 11, 2010
First Submitted That Met QC Criteria
January 12, 2010
First Posted (Estimate)
January 13, 2010
Study Record Updates
Last Update Posted (Actual)
April 25, 2022
Last Update Submitted That Met QC Criteria
March 28, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
- hypertriglyceridemia
- lipids
- triglycerides
- HDL
- cholesterol
- atorvastatin
- rosuvastatin
- Lipitor
- omega-3 fatty acids
- simvastatin
- fibrates
- fish
- dyslipidemia
- lipid
- statin
- LDL
- Lovaza
- EPA
- docosahexaenoic acid
- Crestor
- icosapent ethyl
- fluvastatin
- pravastatin
- ezetimibe
- fatty acids
- ethyl-EPA
- niacin
- Zocor
- Zetia
- lovastatin
- Trilipix
- Vytorin
- Simcor
- Niaspan
- ethyl icosapentate
- VASCEPA
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMR-01-01-0017
- The ANCHOR Study (Other Identifier: Amarin Pharma Inc.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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