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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amarin Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01047501
First received: January 11, 2010
Last updated: November 5, 2013
Last verified: November 2013

January 11, 2010
November 5, 2013
December 2009
February 2011   (final data collection date for primary outcome measure)
Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01047501 on ClinicalTrials.gov Archive Site
Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in other lipid and biomarker levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertriglyceridemia
  • Drug: AMR101 (ethyl icosapentate)
    AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
  • Drug: AMR101 (ethyl icosapentate)
    AMR101 (ethyl icosapentate) 2 capsules/day for 12 weeks
  • Drug: Placebo
    Placebo 4 capsules/day for 12 weeks
  • Drug: Placebo
    Placebo 2 capsules/day for 12 weeks
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: AMR101 (ethyl icosapentate) - 2 g/day
    Interventions:
    • Drug: AMR101 (ethyl icosapentate)
    • Drug: Placebo
  • Experimental: AMR101 (ethyl icosapentate) - 4 g/day
    Intervention: Drug: AMR101 (ethyl icosapentate)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
702
Not Provided
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01047501
AMR-01-01-0017, The ANCHOR Study
No
Amarin Pharma Inc.
Amarin Pharma Inc.
Not Provided
Not Provided
Amarin Pharma Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP