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

Hypertriglyceridemia Clinical Trial

— ANCHOR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047501
• Other study ID #: AMR-01-01-0017
• Secondary ID: The ANCHOR Study
• Status: Completed
• Phase: Phase 3
• Start date: December 2009
• Est. completion date: February 2011

Study information

• Verified date: March 2022
• Source: Amarin Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 702
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• AMR101 (ethyl icosapentate) - 4 g/day
AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
• AMR101 (ethyl icosapentate) - 2 g/day
AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
• Placebo
Placebo 4 capsules/day for 12 weeks

Locations

Country	Name	City	State
United States	Amarin Investigational Site	Addison	Illinois
United States	Amarin Investigational Site	Anaheim	California
United States	Amarin Investigational Site	Auburn	Maine
United States	Amarin Investigational Site	Augusta	Georgia
United States	Amarin Investigational Site	Augusta	Georgia
United States	Amarin Investigational Site	Aventura	Florida
United States	Amarin Investigational Site	Baltimore	Maryland
United States	Amarin Investigational Site	Beaver	Pennsylvania
United States	Amarin Investigational Site	Burbank	California
United States	Amarin Investigational Site	Butte	Montana
United States	Amarin Investigational Site	Charlotte	North Carolina
United States	Amarin Investigational Site	Chino	California
United States	Amarin Investigational Site	Cincinnati	Ohio
United States	Amarin Investigational Site	Cincinnati	Ohio
United States	Amarin Investigational Site	Clearwater	Florida
United States	Amarin Investigational Site	Cleveland	Ohio
United States	Amarin Investigational Site	Concord	New Hampshire
United States	Amarin Investigational Site	Coral Gables	Florida
United States	Amarin Investigational Site	Dallas	Texas
United States	Amarin Investigational Site	Durham	North Carolina
United States	Amarin Investigational Site	Elkridge	Maryland
United States	Amarin Investigational Site	Encinitas	California
United States	Amarin Investigational Site	Endwell	New York
United States	Amarin Investigational Site	Ettrick	Virginia
United States	Amarin Investigational Site	Golden	Colorado
United States	Amarin Investigational Site	Harleysville	Pennsylvania
United States	Amarin Investigational Site	Hialeah	Florida
United States	Amarin Investigational Site	Hickory	North Carolina
United States	Amarin Investigational Site	Houston	Texas
United States	Amarin Investigational Site	Houston	Texas
United States	Amarin Investigational Site	Indianapolis	Indiana
United States	Amarin Investigational Site	Irvine	California
United States	Amarin Investigational Site	Jacksonville	Florida
United States	Amarin Investigational Site	Jacksonville	Florida
United States	Amarin Investigational Site	Jersey Shore	Pennsylvania
United States	Amarin Investigational Site	Kansas City	Kansas
United States	Amarin Investigational Site	Kettering	Ohio
United States	Amarin Investigational Site	Lake Jackson	Texas
United States	Amarin Investigational Site	Lansdale	Pennsylvania
United States	Amarin Investigational Site	Los Angeles	California
United States	Amarin Investigational Site	Los Angeles	California
United States	Amarin Investigational Site	Louisville	Kentucky
United States	Amarin Investigational Site	Miami	Florida
United States	Amarin Investigational Site	Morton	Illinois
United States	Amarin Investigational Site	Mount Pleasant	South Carolina
United States	Amarin Investigational Site	Munfordville	Kentucky
United States	Amarin Investigational Site	Muscle Shoals	Alabama
United States	Amarin Investigational Site	New Port Richey	Florida
United States	Amarin Investigational Site	New Port Richey	Florida
United States	Amarin Investigational Site	New Windsor	New York
United States	Amarin Investigational Site	Newton	Kansas
United States	Amarin Investigational Site	Norfolk	Virginia
United States	Amarin Investigational Site	Norman	Oklahoma
United States	Amarin Investigational Site	Olive Branch	Mississippi
United States	Amarin Investigational Site	Orlando	Florida
United States	Amarin Investigational Site	Philadelphia	Pennsylvania
United States	Amarin Investigational Site	Phoenix	Arizona
United States	Amarin Investigational Site	Port Orange	Florida
United States	Amarin Investigational Site	Raleigh	North Carolina
United States	Amarin Investigational Site	Rapid City	South Dakota
United States	Amarin Investigational Site	Richmond	Virginia
United States	Amarin Investigational Site	Richmond	Virginia
United States	Amarin Investigational Site	Saint Louis	Missouri
United States	Amarin Investigational Site	San Antonio	Texas
United States	Amarin Investigational Site	San Antonio	Texas
United States	Amarin Investigational Site	Scottsboro	Alabama
United States	Amarin Investigational Site	Spring Valley	California
United States	Amarin Investigational Site	Statesville	North Carolina
United States	Amarin Investigational Site	Syracuse	New York
United States	Amarin Investigational Site	Temple	Texas
United States	Amarin Investigational Site	Troy	Michigan
United States	Amarin Investigational Site	Tucson	Arizona
United States	Amarin Investigational Site	Tulsa	Oklahoma
United States	Amarin Investigational Site	Wauwatosa	Wisconsin
United States	Amarin Investigational Site	West Palm Beach	Florida
United States	Amarin Investigational Site	Westlake Village	California
United States	Amarin Investigational Site	Wheat Ridge	Colorado
United States	Amarin Investigational Site	Wichita	Kansas
United States	Amarin Investigational Site	Wilmington	North Carolina
United States	Amarin Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amarin Pharma Inc.

Country where clinical trial is conducted

United States, 

References & Publications (13)

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 — View 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 Cardi — View 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;2 — View 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 — View 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( — View 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. M — View 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: 1 — View 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 — View 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 — View 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). — View 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-S — View 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;11 — View 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 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels	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	baseline and 12 weeks
Secondary	Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels	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	baseline and 12 weeks
Secondary	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	baseline and 12 weeks
Secondary	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	baseline and 12 weeks
Secondary	Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels	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	baseline and 12 weeks