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A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Amarin Pharma Inc.
Sponsor:
Information provided by (Responsible Party):
Amarin Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01492361
First received: December 13, 2011
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) being developed by Amarin Pharma Inc. for the treatment of hypertriglyceridemia. The purpose of this study is to evaluate whether this drug, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.


Condition Intervention Phase
Cardiovascular Diseases
Drug: AMR101
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA - Intervention Trial)

Resource links provided by NLM:


Further study details as provided by Amarin Pharma Inc.:

Primary Outcome Measures:
  • Composite endpoint of CV death, MI, stroke, coronary revascularization, and hospitalization for unstable angina. [ Time Frame: 4-6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of additional cardiovascular events, lipid and lipoprotein levels, subgroup analyses such as: diabetics, etc. [ Time Frame: 4-6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 8000
Study Start Date: November 2011
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMR101 Drug: AMR101
Parallel Assignment
Placebo Comparator: Placebo Drug: Placebo
Parallel Assignment

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and non-pregnant or sterile women ages 45 and older
  • Hypertriglyceridemia
  • On statin therapy for at least four weeks
  • Either having established Cardiovascular Disease or at high risk for Cardiovascular Disease

Exclusion Criteria:

  • Severe heart failure
  • Any life-threatening disease other than Cardiovascular Disease
  • Active severe liver disease
  • Hemoglobin A1c >10.0%
  • Poorly controlled hypertension
  • Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure
  • Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)
  • Known hypersensitivity to fish oil products
  • History of acute or chronic pancreatitis
  • Patients are excluded if using the following medications:

    • niacin >200 mg/day or fibrates;
    • any omega-3 fatty acid medications ;
    • dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
    • bile acid sequestrants
  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: NCT01492361

Contacts
Contact: Halina Matusik 516-352-0595 halina.matusik@inventivhealth.com

  Hide Study Locations
Locations
United States, Alabama
Amarin Investigational Site Recruiting
Birmingham, Alabama, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Huntsville, Alabama, United States
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Amarin Investigational Site Recruiting
Mobile, Alabama, United States
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Amarin Investigational Site Recruiting
Muscle Shoals, Alabama, United States
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United States, Arizona
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Chandler, Arizona, United States
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Glendale, Arizona, United States
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Goodyear, Arizona, United States
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Green Valley, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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United States, Arkansas
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Little Rock, Arkansas, United States
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United States, California
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Azusa, California, United States
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Beverly Hills, California, United States
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Buena Park, California, United States
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Carmichael, California, United States
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Chino, California, United States
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Concord, California, United States
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Covina, California, United States
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Fair Oaks, California, United States
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Hawaiian Gardens, California, United States
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Inglewood, California, United States
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Lincoln, California, United States
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Los Angeles, California, United States
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Merced, California, United States
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National City, California, United States
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Orange, California, United States
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Orangevale, California, United States
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Paramount, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Stockton, California, United States
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Thousand Oaks, California, United States
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Torrance, California, United States
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Ventura, California, United States
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Walnut Creek, California, United States
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West Covina, California, United States
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West Hills, California, United States
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Westlake Village, California, United States
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United States, Colorado
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Golden, Colorado, United States
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Longmont, Colorado, United States
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United States, Connecticut
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Guilford, Connecticut, United States
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Hartford, Connecticut, United States
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United States, Delaware
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Newark, Delaware, United States
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United States, District of Columbia
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Washington, District of Columbia, United States
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United States, Florida
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Boynton Beach, Florida, United States
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Clearwater, Florida, United States
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Edgewater, Florida, United States
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Fleming Island, Florida, United States
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Fort Lauderdale, Florida, United States
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Hollywood, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Key West, Florida, United States
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Lauderdale Lakes, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Amarin Investigational Site Recruiting
Safety Harbor, Florida, United States
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Amarin Investigational Site Recruiting
Sarasota, Florida, United States
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Amarin Investigational Site Recruiting
West Palm Beach, Florida, United States
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United States, Georgia
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Atlanta, Georgia, United States
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Amarin Investigational Site Recruiting
Conyers, Georgia, United States
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Amarin Investigational Site Recruiting
Covington, Georgia, United States
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Amarin Investigational Site Recruiting
Cumming, Georgia, United States
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Amarin Investigational Site Recruiting
Gainesville, Georgia, United States
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Amarin Investigational Site Recruiting
Roswell, Georgia, United States
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Amarin Investigational Site Recruiting
Sandy Springs, Georgia, United States
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United States, Hawaii
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Honolulu, Hawaii, United States
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United States, Illinois
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Addison, Illinois, United States
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Chicago, Illinois, United States
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Downers Grove, Illinois, United States
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Glen Ellyn, Illinois, United States
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Amarin Investigational Site Recruiting
Hines, Illinois, United States
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Amarin Investigational Site Recruiting
Norman, Illinois, United States
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Amarin Investigational Site Recruiting
North Chicago, Illinois, United States
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Amarin Investigational Site Recruiting
Peoria, Illinois, United States
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United States, Indiana
Amarin Investigational Site Recruiting
Evansville, Indiana, United States
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United States, Iowa
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Iowa City, Iowa, United States
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United States, Kansas
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Wichita, Kansas, United States
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United States, Kentucky
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Louisville, Kentucky, United States
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United States, Louisiana
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Alexandria, Louisiana, United States
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Covington, Louisiana, United States
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Eunice, Louisiana, United States
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Marrero, Louisiana, United States
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United States, Maine
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Auburn, Maine, United States
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United States, Maryland
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Baltimore, Maryland, United States
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Lutherville, Maryland, United States
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Amarin Investigational Site Recruiting
Olney, Maryland, United States
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Amarin Investigational Site Recruiting
Phoenix, Maryland, United States
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Amarin Investigational Site Recruiting
Takoma Park, Maryland, United States
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United States, Massachusetts
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Boston, Massachusetts, United States
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Amarin Investigational Site Recruiting
Fall River, Massachusetts, United States
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United States, Michigan
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Lansing, Michigan, United States
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Marquette, Michigan, United States
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Troy, Michigan, United States
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United States, Minnesota
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Minneapolis, Minnesota, United States
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Amarin Investigational Site Recruiting
St. Cloud, Minnesota, United States
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United States, Mississippi
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Biloxi, Mississippi, United States
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Columbus, Mississippi, United States
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Tupelo, Mississippi, United States
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United States, Missouri
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Florissant, Missouri, United States
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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St. Louis, Missouri, United States
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United States, Nebraska
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Hastings, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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United States, Nevada
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Sparks, Nevada, United States
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United States, New Jersey
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Monmouth Junction, New Jersey, United States
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Ocean, New Jersey, United States
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United States, New Mexico
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Albuquerque, New Mexico, United States
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United States, New York
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Great Neck, New York, United States
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Johnson City, New York, United States
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New York, New York, United States
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Amarin Investigational Site Recruiting
North Massapequa, New York, United States
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Amarin Investigational Site Recruiting
Syracuse, New York, United States
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Amarin Investigational Site Recruiting
West Seneca, New York, United States
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United States, North Carolina
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Charlotte, North Carolina, United States
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Amarin Investigational Site Recruiting
Durham, North Carolina, United States
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Amarin Investigational Site Recruiting
Gastonia, North Carolina, United States
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Amarin Investigational Site Recruiting
Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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United States, North Dakota
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Fargo, North Dakota, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
United States, Ohio
Amarin Investigational Site Recruiting
Cincinnati, Ohio, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Kettering, Ohio, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Lorain, Ohio, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Sandusky, Ohio, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
United States, Oklahoma
Amarin Investigational Site Recruiting
Oklahoma City, Oklahoma, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Tulsa, Oklahoma, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
United States, Oregon
Amarin Investigational Site Recruiting
Bend, Oregon, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
United States, Pennsylvania
Amarin Investigational Site Recruiting
Beaver, Pennsylvania, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Camp Hill, Pennsylvania, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Doylestown, Pennsylvania, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Jersey Shore, Pennsylvania, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Newport, Pennsylvania, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Philadelphia, Pennsylvania, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Phoenixville, Pennsylvania, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Sellersville, Pennsylvania, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Tipton, Pennsylvania, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Wyomissing, Pennsylvania, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Yardley, Pennsylvania, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
United States, South Carolina
Amarin Investigational Site Recruiting
Simpsonville, South Carolina, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
United States, South Dakota
Amarin Investigational Site Recruiting
Rapid City, South Dakota, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
United States, Tennessee
Amarin Investigational Site Recruiting
Bristol, Tennessee, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Columbia, Tennessee, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Germantown, Tennessee, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Knoxville, Tennessee, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Nashville, Tennessee, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Smyrna, Tennessee, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
United States, Texas
Amarin Investigational Site Recruiting
Arlington, Texas, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Austin, Texas, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Beaumont, Texas, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Carrollton, Texas, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Dallas, Texas, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Fort Worth, Texas, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Grapevine, Texas, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Houston, Texas, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Katy, Texas, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Plano, Texas, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
San Antonio, Texas, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Tomball, Texas, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
United States, Utah
Amarin Investigational Site Recruiting
Sandy, Utah, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
West Jordan, Utah, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
United States, Virginia
Amarin Investigational Site Recruiting
Danville, Virginia, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Falls Church, Virginia, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Manassas, Virginia, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Midlothian, Virginia, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Newport News, Virginia, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Norfolk, Virginia, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
United States, Washington
Amarin Investigational Site Recruiting
Burien, Washington, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Tacoma, Washington, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
United States, West Virginia
Amarin Investigational Site Recruiting
Huntington, West Virginia, United States
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Australia, New South Wales
Amarin Investigational Site Recruiting
Camperdown, New South Wales, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
East Gosford, New South Wales, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Lismore, New South Wales, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Australia, Queensland
Amarin Investigational Site Recruiting
Auchenflower, Queensland, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Brisbane, Queensland, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Chermside, Queensland, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Australia, South Australia
Amarin Investigational Site Recruiting
Bedford Park, South Australia, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Australia, Tasmania
Amarin Investigational Site Recruiting
Launceston, Tasmania, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Australia, Victoria
Amarin Investigational Site Recruiting
Fitzroy, Victoria, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Geelong, Victoria, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Heidelberg Heights, Victoria, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Melbourne, Victoria, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Australia, Western Australia
Amarin Investigational Site Recruiting
Bateman, Western Australia, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Fremantle, Western Australia, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Nedlands, Western Australia, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Perth, Western Australia, Australia
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Canada, Alberta
Amarin Investigational Site Recruiting
Edmonton, Alberta, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Canada, British Columbia
Amarin Investigational Site Recruiting
Burnaby, British Columbia, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Coquitlam, British Columbia, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Vancouver, British Columbia, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Canada, Ontario
Amarin Investigational Site Recruiting
Brampton, Ontario, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Collingwood, Ontario, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Corunna, Ontario, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Newmarket, Ontario, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Sarnia, Ontario, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Strathroy, Ontario, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Canada, Quebec
Amarin Investigational Site Recruiting
Laval, Quebec, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Montreal, Quebec, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Québec, Quebec, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Sherbrooke, Quebec, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
St. Charles-Borromée, Quebec, Canada
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
India
Amarin Investigational Site Recruiting
Andhra, Andhra Pradesh, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Hyderabad, Andhra Pradesh, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Visakhapatnam, Andhra Pradesh, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Bangalore, Karnataka, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Belgaum, Karnataka, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Bengaluru, Karnataka, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Mysore, Karnataka, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Kottayam, Kerala, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Thrissur, Kerala, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Mumbai, Maharashtra, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Nashik, Maharashtra, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Pune, Maharashtra, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Jaipur, Rajasthan, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Chennai, Tamil Nadu, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Coimbatore, Tamil Nadu, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
New Delhi, India
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Netherlands
Amarin Investigational Site Recruiting
Almelo, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Amersfoort, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Blaricum, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Breda, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Den Haag, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Den Helder, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Deventer, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Eindhoven, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Enschede, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Goes, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Gorinchem, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Gouda, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Groningen, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Haarlem, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Harderwijk, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Heerenveen, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Heerlen, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Hilversum, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Hoofddorp, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Leeuwarden, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Leiderdorp, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Nijmegen, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Oss, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Roosendaal, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Rotterdam, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
s'Hertogenbosch, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Schiedam, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Sneek, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Tilburg, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Veldhoven, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Velp, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Zoetermeer, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Zutphen, Netherlands
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
New Zealand
Amarin Investigational Site Recruiting
Christchurch, New Zealand
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Dunedin, New Zealand
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Hamilton, New Zealand
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Hastings, New Zealand
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Nelson, New Zealand
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
New Plymouth, New Zealand
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Takapuna, Auckland, New Zealand
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Tauranga, New Zealand
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Whangarei, New Zealand
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Poland
Amarin Investigational Site Recruiting
Bialystok, Poland
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Katowice, Poland
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Kraków, Poland
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Mikolów, Poland
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Skierniewice, Poland
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Tarnów, Poland
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Warszawa, Poland
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Warszawska, Poland
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Wroclaw, Poland
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Zgierz, Poland
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Romania
Amarin Investigational Site Recruiting
Argeş, Romania
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Brăila, Romania
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Bucharest, Romania
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Bucuresti, Romania
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Cluj-Napoca, Romania
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Constanţa, Romania
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Craiova, Dolj, Romania
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Iaşi, Romania
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Maramureş, Romania
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Mureş, Romania
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Amarin Investigational Site Recruiting
Sibiu, Romania
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Amarin Investigational Site Recruiting
Timişoara, Romania
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Amarin Investigational Site Recruiting
Târgu Mureş, Romania
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Russian Federation
Amarin Investigational Site Recruiting
Arkhangelsk, Russian Federation
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Amarin Investigational Site Recruiting
Ekaterinburg, Russian Federation
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Amarin Investigational Site Recruiting
Kazan, Russian Federation
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Amarin Investigational Site Recruiting
Kemerovo, Russian Federation
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Amarin Investigational Site Recruiting
Kirovsk, Russian Federation
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Krasnodar, Russian Federation
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Amarin Investigational Site Recruiting
Moscow, Russian Federation
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Amarin Investigational Site Recruiting
Nizhny Novgorod, Russian Federation
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Novosibirsk, Russian Federation
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Amarin Investigational Site Recruiting
Petrozavodsk, Russian Federation
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Amarin Investigational Site Recruiting
Saint-Petersburg, Russian Federation
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Amarin Investigational Site Recruiting
Saratov, Russian Federation
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Amarin Investigational Site Recruiting
Sestroretsk, Saint-Petersburg, Russian Federation
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Amarin Investigational Site Recruiting
Tomsk, Russian Federation
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Amarin Investigational Site Recruiting
Volgograd, Russian Federation
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Amarin Investigational Site Recruiting
Voronezh, Russian Federation
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Amarin Investigational Site Recruiting
Yaroslavl, Russian Federation
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South Africa
Amarin Investigational Site Recruiting
Newlands, Durban, South Africa
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Bloemfontein, Freestate, South Africa
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Amarin Investigational Site Recruiting
Benoni, Gauteng, South Africa
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Amarin Investigational Site Recruiting
Pretoria, Gauteng, South Africa
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Amarin Investigational Site Recruiting
Soweto, Gauteng, South Africa
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Amarin Investigational Site Recruiting
Witbank, Gauteng, South Africa
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Durban, Kwa Zulu Natal, South Africa
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Amarin Investigational Site Recruiting
Bellville, Western Cape, South Africa
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Amarin Investigational Site Recruiting
Cape Town, Western Cape, South Africa
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Amarin Investigational Site Recruiting
Durbanville, Western Cape, South Africa
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Goodwood, Western Cape, South Africa
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Paarl, Western Cape, South Africa
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Panorama, Western Cape, South Africa
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Amarin Investigational Site Recruiting
Parow, Western Cape, South Africa
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Amarin Investigational Site Recruiting
Pinelands, Western Cape, South Africa
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Amarin Investigational Site Recruiting
Somerset West, Western Cape, South Africa
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Amarin Investigational Site Recruiting
Worcester, Western Cape, South Africa
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Amarin Investigational Site Recruiting
Western Cape, South Africa
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Ukraine
Amarin Investigational Site Recruiting
Lutsk, Volyn Region, Ukraine
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Amarin Investigational Site Recruiting
Cherkasy, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Chernivtsi, Ukraine
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Amarin Investigational Site Recruiting
Dnipropetrovsk, Ukraine
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Amarin Investigational Site Recruiting
Donetsk, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Ivano-Frankivsk, Ukraine
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Amarin Investigational Site Recruiting
Kharkiv, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Kiev, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Kyiv, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Luhansk, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Lutsk, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Lviv, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Odesa, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Poltava, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Simferopol, AR Crimea, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Ternopil, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Uzhgorod, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Vinnytsya, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Zaporizhzhia, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Amarin Investigational Site Recruiting
Zaporozh'ye, Ukraine
Contact: Halina Matusik    516-352-0595    halina.matusik@inventivhealth.com   
Sponsors and Collaborators
Amarin Pharma Inc.
  More Information

No publications provided

Responsible Party: Amarin Pharma Inc.
ClinicalTrials.gov Identifier: NCT01492361     History of Changes
Other Study ID Numbers: AMR-01-01-0019
Study First Received: December 13, 2011
Last Updated: October 11, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
India: Drugs Controller General of India
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Medsafe
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Ukraine: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Amarin Pharma Inc.:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Acute Coronary Syndrome
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
hypertriglyceridemia
omega-3 fatty acids
statin
triglycerides
EPA
docosahexaenoic acid
fish
fatty acids
fibrates
niacin
lipids
lipoprotein
atorvastatin
Lovaza
simvastatin
lovastatin

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014