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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:
Amarin Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01047501
First received: January 11, 2010
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Hypertriglyceridemia
 Drug: AMR101 (ethyl icosapentate)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amarin Pharma Inc.:

Primary Outcome Measures:
  • Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in other lipid and biomarker levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 648
Study Start Date: December 2009
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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) 4 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047501

  Show 81 Study Locations
Sponsors and Collaborators
Amarin Pharma Inc.
Investigators
Principal Investigator: listed below see below
  More Information

No publications provided

Responsible Party: Peggy Berry Vice President and Head of Regulatory Affairs, Amarin Pharma Inc.
ClinicalTrials.gov Identifier: NCT01047501     History of Changes
Other Study ID Numbers: AMR-01-01-0017, The ANCHOR Study
Study First Received: January 11, 2010
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Amarin Pharma Inc.:
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

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
 Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013