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
  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:


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 ]

Enrollment: 702
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) 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Amarin Investigational Site
Muscle Shoals, Alabama, United States, 35662
Amarin Investigational Site
Scottsboro, Alabama, United States, 35768
United States, Arizona
Amarin Investigational Site
Phoenix, Arizona, United States, 85050
Amarin Investigational Site
Tucson, Arizona, United States, 85705
United States, California
Amarin Investigational Site
Anaheim, California, United States, 92801
Amarin Investigational Site
Burbank, California, United States, 91505
Amarin Investigational Site
Chino, California, United States, 91710
Amarin Investigational Site
Encinitas, California, United States, 92024
Amarin Investigational Site
Irvine, California, United States, 92618
Amarin Investigational Site
Los Angeles, California, United States, 90025
Amarin Investigational Site
Los Angeles, California, United States, 90057
Amarin Investigational Site
Spring Valley, California, United States, 91978
Amarin Investigational Site
Westlake Village, California, United States, 91361
United States, Colorado
Amarin Investigational Site
Golden, Colorado, United States, 80401
Amarin Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Amarin Investigational Site
Aventura, Florida, United States, 33180
Amarin Investigational Site
Clearwater, Florida, United States, 33756
Amarin Investigational Site
Coral Gables, Florida, United States, 33134
Amarin Investigational Site
Hialeah, Florida, United States, 33012
Amarin Investigational Site
Jacksonville, Florida, United States, 32223
Amarin Investigational Site
Jacksonville, Florida, United States, 32205
Amarin Investigational Site
Miami, Florida, United States, 33169
Amarin Investigational Site
New Port Richey, Florida, United States, 34652
Amarin Investigational Site
New Port Richey, Florida, United States, 34653
Amarin Investigational Site
Orlando, Florida, United States, 32833
Amarin Investigational Site
Port Orange, Florida, United States, 32127
Amarin Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
Amarin Investigational Site
Augusta, Georgia, United States, 30904
Amarin Investigational Site
Augusta, Georgia, United States, 30909
United States, Illinois
Amarin Investigational Site
Addison, Illinois, United States, 60101
Amarin Investigational Site
Morton, Illinois, United States, 61550
United States, Indiana
Amarin Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Kansas
Amarin Investigational Site
Kansas City, Kansas, United States, 66160
Amarin Investigational Site
Newton, Kansas, United States, 67114
Amarin Investigational Site
Wichita, Kansas, United States, 67205
United States, Kentucky
Amarin Investigational Site
Louisville, Kentucky, United States, 40213
Amarin Investigational Site
Munfordville, Kentucky, United States, 42765
United States, Maine
Amarin Investigational Site
Auburn, Maine, United States, 04210
United States, Maryland
Amarin Investigational Site
Baltimore, Maryland, United States, 21209
Amarin Investigational Site
Elkridge, Maryland, United States, 21075
United States, Michigan
Amarin Investigational Site
Troy, Michigan, United States, 48098
United States, Mississippi
Amarin Investigational Site
Olive Branch, Mississippi, United States, 38654
United States, Missouri
Amarin Investigational Site
St. Louis, Missouri, United States, 63110
United States, Montana
Amarin Investigational Site
Butte, Montana, United States, 59701
United States, New Hampshire
Amarin Investigational Site
Concord, New Hampshire, United States, 03301
United States, New York
Amarin Investigational Site
Endwell, New York, United States, 13760
Amarin Investigational Site
New Windsor, New York, United States, 12553
Amarin Investigational Site
Syracuse, New York, United States, 13202
United States, North Carolina
Amarin Investigational Site
Charlotte, North Carolina, United States, 28277
Amarin Investigational Site
Durham, North Carolina, United States, 27710
Amarin Investigational Site
Hickory, North Carolina, United States, 28601
Amarin Investigational Site
Raleigh, North Carolina, United States, 27527
Amarin Investigational Site
Statesville, North Carolina, United States, 28677
Amarin Investigational Site
Wilmington, North Carolina, United States, 28401
Amarin Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Amarin Investigational Site
Cincinnati, Ohio, United States, 45219
Amarin Investigational Site
Cincinnati, Ohio, United States, 45212
Amarin Investigational Site
Cleveland, Ohio, United States, 44122
Amarin Investigational Site
Kettering, Ohio, United States, 45429
United States, Oklahoma
Amarin Investigational Site
Norman, Oklahoma, United States, 73069
Amarin Investigational Site
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Amarin Investigational Site
Beaver, Pennsylvania, United States, 15009
Amarin Investigational Site
Harleysville, Pennsylvania, United States, 19438
Amarin Investigational Site
Jersey Shore, Pennsylvania, United States, 17740
Amarin Investigational Site
Lansdale, Pennsylvania, United States, 19446
Amarin Investigational Site
Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
Amarin Investigational Site
Mt. Pleasant, South Carolina, United States, 29464
United States, South Dakota
Amarin Investigational Site
Rapid City, South Dakota, United States, 57702
United States, Texas
Amarin Investigational Site
Dallas, Texas, United States, 75230
Amarin Investigational Site
Houston, Texas, United States, 77030
Amarin Investigational Site
Houston, Texas, United States, 77074
Amarin Investigational Site
Lake Jackson, Texas, United States, 77566
Amarin Investigational Site
San Antonio, Texas, United States, 78224
Amarin Investigational Site
San Antonio, Texas, United States, 78229
Amarin Investigational Site
Temple, Texas, United States, 76502
United States, Virginia
Amarin Investigational Site
Ettrick, Virginia, United States, 23803
Amarin Investigational Site
Norfolk, Virginia, United States, 23502
Amarin Investigational Site
Richmond, Virginia, United States, 23294
Amarin Investigational Site
Richmond, Virginia, United States, 23225
United States, Wisconsin
Amarin Investigational Site
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Amarin Pharma Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: 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: November 5, 2013
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 July 23, 2014