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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01047501
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : November 27, 2013
Information provided by (Responsible Party):
Amarin Pharma Inc.

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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: AMR101 (ethyl icosapentate) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 702 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2009
Actual Primary Completion Date : February 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo 4 capsules/day for 12 weeks

Experimental: AMR101 (ethyl icosapentate) - 2 g/day Drug: AMR101 (ethyl icosapentate)
AMR101 (ethyl icosapentate) 2 capsules/day for 12 weeks

Drug: Placebo
Placebo 2 capsules/day for 12 weeks

Experimental: AMR101 (ethyl icosapentate) - 4 g/day Drug: AMR101 (ethyl icosapentate)
AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks

Primary Outcome Measures :
  1. Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in other lipid and biomarker levels [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 <100mg/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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01047501

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Sponsors and Collaborators
Amarin Pharma Inc.

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Amarin Pharma Inc. Identifier: NCT01047501    
Other Study ID Numbers: AMR-01-01-0017
The ANCHOR Study ( Other Identifier: Amarin Pharma Inc. )
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013
Keywords provided by Amarin Pharma Inc.:
omega-3 fatty acids
docosahexaenoic acid
fatty acids
ethyl icosapentate
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors