Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amarin Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01492361
First received: December 13, 2011
Last updated: July 25, 2016
Last verified: July 2016
  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
Endpoint Classification: Safety/Efficacy Study
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: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMR101 Drug: AMR101
Parallel Assignment
Other Name: VASCEPA® (icosapent ethyl)
Placebo Comparator: Placebo Drug: Placebo
Parallel Assignment

  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
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 the study product, fish and/or shellfish, or placebo
  • 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

  Hide Study Locations
Locations
United States, Alabama
Amarin Investigational Site
Birmingham, Alabama, United States, 35205
Amarin Investigational Site
Birmingham, Alabama, United States, 35235
Amarin Investigational Site
Huntsville, Alabama, United States, 35801
Amarin Investigational Site
Mobile, Alabama, United States, 36608
Amarin Investigational Site
Muscle Shoals, Alabama, United States, 35662
United States, Arizona
Amarin Investigational Site
Mesa, Arizona, United States, 85206
Amarin Investigational Site
Phoenix, Arizona, United States, 85251
Amarin Investigational Site
Tucson, Arizona, United States, 85745
United States, Arkansas
Amarin Investigational Site
Little Rock, Arkansas, United States, 72204
United States, California
Amarin Investigational Site
Beverly Hills, California, United States, 90211
Amarin Investigational Site
Chino, California, United States, 91710
Amarin Investigational Site
Concord, California, United States, 94520
Amarin Investigational Site
El Cajon, California, United States, 92020
Amarin Investigational Site
Encino, California, United States, 91436
Amarin Investigational Site
Fair Oaks, California, United States, 95628
Amarin Investigational Site
Hawaiian Gardens, California, United States, 90716
Amarin Investigational Site
Lancaster, California, United States, 93534
Amarin Investigational Site
Lincoln, California, United States, 95648
Amarin Investigational Site
Los Angeles, California, United States, 90015
Amarin Investigational Site
Los Angeles, California, United States, 90017
Amarin Investigational Site
Los Angeles, California, United States, 90033
Amarin Investigational Site
National City, California, United States, 91950
Amarin Investigational Site
Orange, California, United States, 92868
Amarin Investigational Site
Paramount, California, United States, 90723
Amarin Investigational Site
Roseville, California, United States, 95661
Amarin Investigational Site
San Diego, California, United States, 92123
Amarin Investigational Site
Torrance, California, United States, 90502
Amarin Investigational Site
Ventura, California, United States, 93003
Amarin Investigational Site
Walnut Creek, California, United States, 94598
United States, Colorado
Amarin Investigational Site
Aurora, Colorado, United States, 80012
Amarin Investigational Site
Colorado Springs, Colorado, United States, 80909
Amarin Investigational Site
Golden, Colorado, United States, 80401
United States, Connecticut
Amarin Investigational Site
Guilford, Connecticut, United States, 06437
Amarin Investigational Site
Hartford, Connecticut, United States, 06102
United States, Delaware
Amarin Investigational Site
Newark, Delaware, United States, 19718
Amarin Investigational Site
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Amarin Investigational Site
Washington, District of Columbia, United States, 20037
United States, Florida
Amarin Investigational Site
Boynton Beach, Florida, United States, 33437
Amarin Investigational Site
Bradenton, Florida, United States, 34209
Amarin Investigational Site
Clearwater, Florida, United States, 33756
Amarin Investigational Site
Edgewater, Florida, United States, 32132
Amarin Investigational Site
Fleming Island, Florida, United States, 32003
Amarin Investigational Site
Fort Lauderdale, Florida, United States, 33308
Amarin Investigational Site
Fort Lauderdale, Florida, United States, 33312
Amarin Investigational Site
Inverness, Florida, United States, 34429
Amarin Investigational Site
Jacksonville, Florida, United States, 32204
Amarin Investigational Site
Jacksonville, Florida, United States, 32205
Amarin Investigational Site
Jacksonville, Florida, United States, 32207
Amarin Investigational Site
Jacksonville, Florida, United States, 32216
Amarin Investigational Site
Miami Beach, Florida, United States, 33140
Amarin Investigational Site
Miami Lakes, Florida, United States, 33014
Amarin Investigational Site
Miami, Florida, United States, 33144
Amarin Investigational Site
Miami, Florida, United States, 33175
Amarin Investigational Site
Ocala, Florida, United States, 34471
Amarin Investigational Site
Orlando, Florida, United States, 32803
Amarin Investigational Site
Pembroke Pines, Florida, United States, 33026
Amarin Investigational Site
Plantation, Florida, United States, 33324
Amarin Investigational Site
Safety Harbor, Florida, United States, 34695
Amarin Investigational Site
Sarasota, Florida, United States, 34233
Amarin Investigational Site
St. Petersburg, Florida, United States, 33713
Amarin Investigational Site
Vero Beach, Florida, United States, 32960
Amarin Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
Amarin Investigational Site
Conyers, Georgia, United States, 30094
Amarin Investigational Site
Covington, Georgia, United States, 30014
Amarin Investigational Site
Cumming, Georgia, United States, 30041
Amarin Investigational Site
Roswell, Georgia, United States, 30076
United States, Hawaii
Amarin Investigational Site
Honolulu, Hawaii, United States, 96818
United States, Illinois
Amarin Investigational Site
Addison, Illinois, United States, 60101
Amarin Investigational Site
Chicago, Illinois, United States, 60611
Amarin Investigational Site
Norman, Illinois, United States, 61761
Amarin Investigational Site
North Chicago, Illinois, United States, 60064
Amarin Investigational Site
Peoria, Illinois, United States, 61636
Amarin Investigational Site
Winfield, Illinois, United States, 60190
United States, Indiana
Amarin Investigational Site
Evansville, Indiana, United States, 47713
United States, Iowa
Amarin Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kansas
Amarin Investigational Site
Wichita, Kansas, United States, 67203
Amarin Investigational Site
Wichita, Kansas, United States, 67207
United States, Kentucky
Amarin Investigational Site
Louisville, Kentucky, United States, 40213
United States, Louisiana
Amarin Investigational Site
Alexandria, Louisiana, United States, 71301
Amarin Investigational Site
Eunice, Louisiana, United States, 70535
Amarin Investigational Site
Marrero, Louisiana, United States, 70072
United States, Maine
Amarin Investigational Site
Auburn, Maine, United States, 04210
United States, Maryland
Amarin Investigational Site
Baltimore, Maryland, United States, 21236
Amarin Investigational Site
Lutherville, Maryland, United States, 21093
Amarin Investigational Site
Takoma Park, Maryland, United States, 20912
United States, Massachusetts
Amarin Investigational Site
Boston, Massachusetts, United States, 02118
Amarin Investigational Site
Boston, Massachusetts, United States, 02215
Amarin Investigational Site
Fall River, Massachusetts, United States, 02721
United States, Michigan
Amarin Investigational Site
Lansing, Michigan, United States, 48910
Amarin Investigational Site
Marquette, Michigan, United States, 49855
Amarin Investigational Site
Troy, Michigan, United States, 48098
United States, Minnesota
Amarin Investigational Site
St. Cloud, Minnesota, United States, 56303
United States, Mississippi
Amarin Investigational Site
Biloxi, Mississippi, United States, 39531
Amarin Investigational Site
Tupelo, Mississippi, United States, 38801
United States, Missouri
Amarin Investigational Site
Chesterfield, Missouri, United States, 63141
Amarin Investigational Site
Florissant, Missouri, United States, 63031
Amarin Investigational Site
Jefferson City, Missouri, United States, 65109
Amarin Investigational Site
Kansas City, Missouri, United States, 64114
Amarin Investigational Site
St. Louis, Missouri, United States, 63110
Amarin Investigational Site
St. Peters, Missouri, United States, 63303
United States, Nebraska
Amarin Investigational Site
Hastings, Nebraska, United States, 68901
Amarin Investigational Site
Omaha, Nebraska, United States, 68114
Amarin Investigational Site
Omaha, Nebraska, United States, 68154
United States, Nevada
Amarin Investigational Site
Henderson, Nevada, United States, 89052
Amarin Investigational Site
Las Vegas, Nevada, United States, 89101
United States, New Jersey
Amarin Investigational Site
Ocean, New Jersey, United States, 07712
United States, New Mexico
Amarin Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Amarin Investigational Site
Albany, New York, United States, 12206
Amarin Investigational Site
Brooklyn, New York, United States, 11206
Amarin Investigational Site
Great Neck, New York, United States, 11023
Amarin Investigational Site
Liverpool, New York, United States, 13088
Amarin Investigational Site
New York, New York, United States, 10001
Amarin Investigational Site
New York, New York, United States, 10016
Amarin Investigational Site
North Massapequa, New York, United States, 11758
Amarin Investigational Site
Smithtown, New York, United States, 11787
Amarin Investigational Site
Vestal, New York, United States, 13850
Amarin Investigational Site
West Seneca, New York, United States, 14224
United States, North Carolina
Amarin Investigational Site
Charlotte, North Carolina, United States, 28204
Amarin Investigational Site
Durham, North Carolina, United States, 27710
Amarin Investigational Site
Gastonia, North Carolina, United States, 28054
Amarin Investigational Site
Kernersville, North Carolina, United States, 27284
Amarin Investigational Site
Raleigh, North Carolina, United States, 27609
Amarin Investigational Site
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Amarin Investigational Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Amarin Investigational Site
Cincinnati, Ohio, United States, 45219
Amarin Investigational Site
Dayton, Ohio, United States, 45419
Amarin Investigational Site
Lorain, Ohio, United States, 44053
Amarin Investigational Site
Sandusky, Ohio, United States, 44870
United States, Oklahoma
Amarin Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Amarin Investigational Site
Bend, Oregon, United States, 97702
Amarin Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Amarin Investigational Site
Beaver, Pennsylvania, United States, 15009
Amarin Investigational Site
Doylestown, Pennsylvania, United States, 18901
Amarin Investigational Site
Jersey Shore, Pennsylvania, United States, 17740
Amarin Investigational Site
Newport, Pennsylvania, United States, 17074
Amarin Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Amarin Investigational Site
Phoenixville, Pennsylvania, United States, 19460
Amarin Investigational Site
Sellersville, Pennsylvania, United States, 18960
Amarin Investigational Site
Tipton, Pennsylvania, United States, 16684
Amarin Investigational Site
Wyomissing, Pennsylvania, United States, 19610
Amarin Investigational Site
Yardley, Pennsylvania, United States, 19067
United States, South Carolina
Amarin Investigational Site
Lancaster, South Carolina, United States, 29720
Amarin Investigational Site
Simpsonville, South Carolina, United States, 29681
United States, South Dakota
Amarin Investigational Site
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Amarin Investigational Site
Bristol, Tennessee, United States, 37620
Amarin Investigational Site
Columbia, Tennessee, United States, 38401
Amarin Investigational Site
Germantown, Tennessee, United States, 38138
Amarin Investigational Site
Jackson, Tennessee, United States, 38301
Amarin Investigational Site
Knoxville, Tennessee, United States, 37917
Amarin Investigational Site
Smyrna, Tennessee, United States, 37167
United States, Texas
Amarin Investigational Site
Austin, Texas, United States, 78756
Amarin Investigational Site
Beaumont, Texas, United States, 77702
Amarin Investigational Site
Carrollton, Texas, United States, 75007
Amarin Investigational Site
Dallas, Texas, United States, 75231
Amarin Investigational Site
Houston, Texas, United States, 77024
Amarin Investigational Site
Houston, Texas, United States, 77025
Amarin Investigational Site
Houston, Texas, United States, 77030
Amarin Investigational Site
Houston, Texas, United States, 77053
Amarin Investigational Site
Houston, Texas, United States, 77070
Amarin Investigational Site
Houston, Texas, United States, 77077
Amarin Investigational Site
Houston, Texas, United States, 77079
Amarin Investigational Site
Hurst, Texas, United States, 76054
Amarin Investigational Site
New Braunfels, Texas, United States, 78130
Amarin Investigational Site
Plano, Texas, United States, 75075
Amarin Investigational Site
San Antonio, Texas, United States, 78228
Amarin Investigational Site
San Antonio, Texas, United States, 78238
Amarin Investigational Site
Splendora, Texas, United States, 77372
Amarin Investigational Site
Tomball, Texas, United States, 77375
United States, Utah
Amarin Investigational Site
West Jordan, Utah, United States, 84088
United States, Virginia
Amarin Investigational Site
Falls Church, Virginia, United States, 22044
Amarin Investigational Site
Manassas, Virginia, United States, 20109
Amarin Investigational Site
Midlothian, Virginia, United States, 23114
Amarin Investigational Site
Newport News, Virginia, United States, 23606
United States, Washington
Amarin Investigational Site
Burien, Washington, United States, 98166
Amarin Investigational Site
Tacoma, Washington, United States, 98405
United States, West Virginia
Amarin Investigational Site
Huntington, West Virginia, United States, 25701
Australia, New South Wales
Amarin Investigational Site
Camperdown, New South Wales, Australia, 2015
Amarin Investigational Site
Lismore, New South Wales, Australia, 2480
Australia, Queensland
Amarin Investigational Site
Brisbane, Queensland, Australia, 4064
Amarin Investigational Site
Chermside, Queensland, Australia, 4032
Australia, South Australia
Amarin Investigational Site
Bedford Park, South Australia, Australia, 5042
Australia, Tasmania
Amarin Investigational Site
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Amarin Investigational Site
Fitzroy, Victoria, Australia, 3065
Amarin Investigational Site
Geelong, Victoria, Australia, 3220
Amarin Investigational Site
Heidelberg Heights, Victoria, Australia, 3081
Amarin Investigational Site
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Amarin Investigational Site
Fremantle, Western Australia, Australia, 6160
Amarin Investigational Site
Joondalup, Western Australia, Australia, 6027
Amarin Investigational Site
Murdoch, Western Australia, Australia, 6150
Amarin Investigational Site
Nedlands, Western Australia, Australia, 6009
Amarin Investigational Site
Perth, Western Australia, Australia, 6000
Canada, Alberta
Amarin Investigational Site
Edmonton, Alberta, Canada, T5A 4L8
Canada, British Columbia
Amarin Investigational Site
Coquitlam, British Columbia, Canada, V3K 3V9
Amarin Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Amarin Investigational Site
Vancouver, British Columbia, Canada, V6Z1Y6
Canada, Ontario
Amarin Investigational Site
Brampton, Ontario, Canada, L6Z 4N5
Amarin Investigational Site
Collingwood, Ontario, Canada, L9Y 1W3
Amarin Investigational Site
Corunna, Ontario, Canada, N0N 1G0
Amarin Investigational Site
Newmarket, Ontario, Canada, L3Y 5G8
Amarin Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
Amarin Investigational Site
Strathroy, Ontario, Canada, N7G 1Y7
Canada, Quebec
Amarin Investigational Site
Laval, Quebec, Canada, H7T 2P5
Amarin Investigational Site
Montreal, Quebec, Canada, H1T 1C8
Amarin Investigational Site
Montreal, Quebec, Canada, H3H 1A1
Amarin Investigational Site
Québec, Quebec, Canada, G1V 4G5
Amarin Investigational Site
Québec, Quebec, Canada, G1V 4M6
Amarin Investigational Site
Sherbrooke, Quebec, Canada, J1J 2E3
Amarin Investigational Site
St. Charles-Borromée, Quebec, Canada, J6E 6J2
India
Amarin Investigational Site
Hyderabad, Andhra Pradesh, India, 500001
Amarin Investigational Site
Hyderabad, Andhra Pradesh, India, 500004
Amarin Investigational Site
Secunderabad, Andhra Pradesh, India, 500003
Amarin Investigational Site
Visakhapatnam, Andhra Pradesh, India, 530013
Amarin Investigational Site
New Delhi, Delhi, India, 110025
Amarin Investigational Site
New Delhi, Delhi, India, 110060
Amarin Investigational Site
Bangalore, Karnataka, India, 560034
Amarin Investigational Site
Bangalore, Karnataka, India, 560038
Amarin Investigational Site
Bangalore, Karnataka, India, 560052
Amarin Investigational Site
Mysore, Karnataka, India, 570015
Amarin Investigational Site
Mysore, Karnataka, India, 570020
Amarin Investigational Site
Kottayam, Kerala, India, 686016
Amarin Investigational Site
Mumbai, Maharashtra, India, 422055
Amarin Investigational Site
Nashik, Maharashtra, India, 422005
Amarin Investigational Site
Pune, Maharashtra, India, 411004
Amarin Investigational Site
Chennai, Tamil Nadu, India, 600086
Amarin Investigational Site
Coimbatore, Tamil Nadu, India, 641037
Netherlands
Amarin Investigational Site
Almelo, Netherlands, 7600 SZ
Amarin Investigational Site
Amersfoort, Netherlands, 3813 TZ
Amarin Investigational Site
Blaricum, Netherlands, 1261 AN
Amarin Investigational Site
Capelle aan den Ijssel, Netherlands, 2906 ZC
Amarin Investigational Site
Den Haag, Netherlands, 2597 AX
Amarin Investigational Site
Den Helder, Netherlands, 1782 GZ
Amarin Investigational Site
Deventer, Netherlands, 7416 SE
Amarin Investigational Site
Ede, Netherlands, 6716 RP
Amarin Investigational Site
Eindhoven, Netherlands, 5611 NV
Amarin Investigational Site
Enschede, Netherlands, 7513 ER
Amarin Investigational Site
Goes, Netherlands, 4462 RA
Amarin Investigational Site
Gorinchem, Netherlands, 4204 AA
Amarin Investigational Site
Gouda, Netherlands, 2803 HH
Amarin Investigational Site
Groningen, Netherlands, 9728 NT
Amarin Investigational Site
Haarlem, Netherlands, 2035 RC
Amarin Investigational Site
Harderwijk, Netherlands, 3844 DG
Amarin Investigational Site
Heerenveen, Netherlands, 8441 PW
Amarin Investigational Site
Heerlen, Netherlands, 6419 PC
Amarin Investigational Site
Hoofddorp, Netherlands, 2134 TM
Amarin Investigational Site
Leeuwarden, Netherlands, 8934 AD
Amarin Investigational Site
Leiderdorp, Netherlands, 2353 GA
Amarin Investigational Site
Nijmegen, Netherlands, 6532 SZ
Amarin Investigational Site
Roosendaal, Netherlands, 4708 AE
Amarin Investigational Site
Rotterdam, Netherlands, 3021 HC
Amarin Investigational Site
Rotterdam, Netherlands, 3045 PM
Amarin Investigational Site
Rotterdam, Netherlands, 3083 AN
Amarin Investigational Site
s'Hertogenbosch, Netherlands, 5223 GV
Amarin Investigational Site
Schiedam, Netherlands, 3118 JH
Amarin Investigational Site
Sneek, Netherlands, 8601 ZK
Amarin Investigational Site
Tilburg, Netherlands, 5022 GC
Amarin Investigational Site
Tilburg, Netherlands, 5042 AD
Amarin Investigational Site
Uden, Netherlands, 5406 PT
Amarin Investigational Site
Veldhoven, Netherlands, 5504 DB
Amarin Investigational Site
Zoetermeer, Netherlands, 2725 NA
Amarin Investigational Site
Zutphen, Netherlands, 7207 AE
New Zealand
Amarin Investigational Site
Takapuna, Auckland, New Zealand, 0622
Amarin Investigational Site
Christchurch, New Zealand, 8011
Amarin Investigational Site
Dunedin, New Zealand, 9016
Amarin Investigational Site
Hamilton, New Zealand, 3240
Amarin Investigational Site
Hastings, New Zealand, 4120
Amarin Investigational Site
Nelson, New Zealand, 7010
Amarin Investigational Site
New Plymouth, New Zealand, 4342
Amarin Investigational Site
Takapuna, Auckland, New Zealand, 0622
Amarin Investigational Site
Tauranga, New Zealand, 3112
Amarin Investigational Site
Whangarei, New Zealand, 0110
Poland
Amarin Investigational Site
Bialystok, Poland, 15-351
Amarin Investigational Site
Bialystok, Poland, 15-875
Amarin Investigational Site
Katowice, Poland, 40-748
Amarin Investigational Site
Katowice, Poland, 40-772
Amarin Investigational Site
Kraków, Poland, 31-011
Amarin Investigational Site
Mikolów, Poland, 43-190
Amarin Investigational Site
Skierniewice, Poland, 96-100
Amarin Investigational Site
Tarnów, Poland, 33-100
Amarin Investigational Site
Warszawa, Poland, 01-231
Amarin Investigational Site
Warszawa, Poland, 04-628
Amarin Investigational Site
Warszawska, Poland, 01-192
Amarin Investigational Site
Wroclaw, Poland, 50-088
Amarin Investigational Site
Wroclaw, Poland, 50-315
Amarin Investigational Site
Zgierz, Poland, 95-100
Romania
Amarin Investigational Site
Argeş, Romania, 110084
Amarin Investigational Site
Brăila, Romania, 810249
Amarin Investigational Site
Bucharest, Romania, 010628
Amarin Investigational Site
Bucharest, Romania, 050098
Amarin Investigational Site
Bucharest, Romania, 050524
Amarin Investigational Site
Bucuresti, Romania, 011234
Amarin Investigational Site
Bucuresti, Romania, 0200054
Amarin Investigational Site
Bucuresti, Romania, 061098
Amarin Investigational Site
Cluj-Napoca, Romania, 400006
Amarin Investigational Site
Constanţa, Romania, 900203
Amarin Investigational Site
Craiova, Dolj, Romania, 200030
Amarin Investigational Site
Iaşi, Romania, 700661
Amarin Investigational Site
Maramureş, Romania, 430123
Amarin Investigational Site
Mureş, Romania, 540098
Amarin Investigational Site
Sibiu, Romania, 550245
Amarin Investigational Site
Timişoara, Romania, 300359
Amarin Investigational Site
Târgu Mureş, Romania, 540136
Russian Federation
Amarin Investigational Site
Arkhangelsk, Russian Federation, 163000
Amarin Investigational Site
Arkhangelsk, Russian Federation, 163001
Amarin Investigational Site
Arkhangelsk, Russian Federation, 163045
Amarin Investigational Site
Ekaterinburg, Russian Federation, 620102
Amarin Investigational Site
Ekaterinburg, Russian Federation, 620109
Amarin Investigational Site
Kazan, Russian Federation, 420012
Amarin Investigational Site
Kazan, Russian Federation, 420097
Amarin Investigational Site
Kemerovo, Russian Federation, 650000
Amarin Investigational Site
Kemerovo, Russian Federation, 650002
Amarin Investigational Site
Kirovsk, Leningradskaya region, Russian Federation, 187342
Amarin Investigational Site
Krasnodar, Russian Federation, 350086
Amarin Investigational Site
Moscow, Russian Federation, 109240
Amarin Investigational Site
Moscow, Russian Federation, 111020
Amarin Investigational Site
Moscow, Russian Federation, 111539
Amarin Investigational Site
Moscow, Russian Federation, 115093
Amarin Investigational Site
Moscow, Russian Federation, 117292
Amarin Investigational Site
Moscow, Russian Federation, 117593
Amarin Investigational Site
Moscow, Russian Federation, 117630
Amarin Investigational Site
Moscow, Russian Federation, 117997
Amarin Investigational Site
Moscow, Russian Federation, 121374
Amarin Investigational Site
Moscow, Russian Federation, 121552
Amarin Investigational Site
Moscow, Russian Federation, 124489
Amarin Investigational Site
Nizhny Novgorod, Russian Federation, 603126
Amarin Investigational Site
Novosibirsk, Russian Federation, 630008
Amarin Investigational Site
Novosibirsk, Russian Federation, 630047
Amarin Investigational Site
Novosibirsk, Russian Federation, 630089
Amarin Investigational Site
Petrozavodsk, Russian Federation, 185000
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 190000
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 190107
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 192283
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 194044
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 194156
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 194291
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 194354
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 196601
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 197022
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 197110
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 197227
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 197341
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 197729
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 198205
Amarin Investigational Site
Saint-Petersburg, Russian Federation, 199106
Amarin Investigational Site
Saratov, Russian Federation, 410002
Amarin Investigational Site
Saratov, Russian Federation, 410028
Amarin Investigational Site
Sestroretsk, Saint-Petersburg, Russian Federation, 197706
Amarin Investigational Site
Tomsk, Russian Federation, 634050
Amarin Investigational Site
Tomsk, Russian Federation, 643012
Amarin Investigational Site
Volgograd, Russian Federation, 400001
Amarin Investigational Site
Voronezh, Russian Federation, 394018
Amarin Investigational Site
Voronezh, Russian Federation, 394065
Amarin Investigational Site
Yaroslavl, Russian Federation, 150030
Amarin Investigational Site
Yaroslavl, Russian Federation, 150062
South Africa
Amarin Investigational Site
Bloemfontein, Freestate, South Africa, 9301
Amarin Investigational Site
Benoni, Gauteng, South Africa, 1500
Amarin Investigational Site
Pretorio, Gauteng, South Africa, 0157
Amarin Investigational Site
Soweto, Gauteng, South Africa, 2013
Amarin Investigational Site
Witbank, Gauteng, South Africa, 1035
Amarin Investigational Site
Durban, KwaZulu-Natal, South Africa, 4001
Amarin Investigational Site
Newlands, KwaZulu-Natal, South Africa, 4037
Amarin Investigational Site
Bellville, Western Cape, South Africa, 7530
Amarin Investigational Site
Cape Town, Western Cape, South Africa, 7925
Amarin Investigational Site
Durbanville, Western Cape, South Africa, 7550
Amarin Investigational Site
Goodwood, Western Cape, South Africa, 7460
Amarin Investigational Site
Kraaifontein, Western Cape, South Africa, 7570
Amarin Investigational Site
Paarl, Western Cape, South Africa, 7646
Amarin Investigational Site
Panorama, Western Cape, South Africa, 7500
Amarin Investigational Site
Parow, Western Cape, South Africa, 7500
Amarin Investigational Site
Pinelands, Western Cape, South Africa, 7405
Amarin Investigational Site
Somerset West, Western Cape, South Africa, 7130
Amarin Investigational Site
Worcester, Western Cape, South Africa, 6850
Ukraine
Amarin Investigational Site
Lutsk, Volyn Region, Ukraine, 43000
Amarin Investigational Site
Cherkasy, Ukraine, 18009
Amarin Investigational Site
Chernivtsi, Ukraine, 58002
Amarin Investigational Site
Dnipropetrovsk, Ukraine, 49006
Amarin Investigational Site
Dnipropetrovsk, Ukraine, 49023
Amarin Investigational Site
Dnipropetrovsk, Ukraine, 49027
Amarin Investigational Site
Donetsk, Ukraine, 83001
Amarin Investigational Site
Donetsk, Ukraine, 83045
Amarin Investigational Site
Ivano-Frankivsk, Ukraine, 76005
Amarin Investigational Site
Ivano-Frankivsk, Ukraine, 76018
Amarin Investigational Site
Kharkiv, Ukraine, 61002
Amarin Investigational Site
Kharkiv, Ukraine, 61018
Amarin Investigational Site
Kharkiv, Ukraine, 61039
Amarin Investigational Site
Kharkiv, Ukraine, 61176
Amarin Investigational Site
Kyiv, Ukraine, 01032
Amarin Investigational Site
Kyiv, Ukraine, 01103
Amarin Investigational Site
Kyiv, Ukraine, 01151
Amarin Investigational Site
Kyiv, Ukraine, 01601
Amarin Investigational Site
Kyiv, Ukraine, 02091
Amarin Investigational Site
Kyiv, Ukraine, 02660
Amarin Investigational Site
Kyiv, Ukraine, 03151
Amarin Investigational Site
Kyiv, Ukraine, 04050
Amarin Investigational Site
Kyiv, Ukraine, 04114
Amarin Investigational Site
Luhansk, Ukraine, 91016
Amarin Investigational Site
Lutsk, Ukraine, 43024
Amarin Investigational Site
Lviv, Ukraine, 79034
Amarin Investigational Site
Odesa, Ukraine, 65009
Amarin Investigational Site
Odesa, Ukraine, 65025
Amarin Investigational Site
Odesa, Ukraine, 65082
Amarin Investigational Site
Poltava, Ukraine, 36011
Amarin Investigational Site
Ternopil, Ukraine, 46003
Amarin Investigational Site
Uzhgorod, Ukraine, 88000
Amarin Investigational Site
Uzhgorod, Ukraine, 88014
Amarin Investigational Site
Vinnytsya, Ukraine, 21018
Amarin Investigational Site
Vinnytsya, Ukraine, 21029
Amarin Investigational Site
Zaporizhzhia, Ukraine, 69035
Amarin Investigational Site
Zaporizhzhia, Ukraine, 69065
Amarin Investigational Site
Zaporizhzhia, Ukraine, 69106
Amarin Investigational Site
Zaporizhzhia, Ukraine, 69600
Sponsors and Collaborators
Amarin Pharma Inc.
Investigators
Principal Investigator: Deepak L. Bhatt, MD, MPH Brigham and Women's Hospital, 75 Francis Street, Boston
  More Information

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: July 25, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
India: Drugs Controller General of India
The 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
Individual Participant Data  
Plan to Share IPD: Undecided

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
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on December 02, 2016