A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin (REDUCE-IT)

March 21, 2022 updated by: Amarin Pharma Inc.

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)

AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study was 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8179

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2015
        • Amarin Investigational Site
      • Lismore, New South Wales, Australia, 2480
        • Amarin Investigational Site
    • Queensland
      • Brisbane, Queensland, Australia, 4064
        • Amarin Investigational Site
      • Chermside, Queensland, Australia, 4032
        • Amarin Investigational Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Amarin Investigational Site
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Amarin Investigational Site
    • Victoria
      • 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
        • Amarin Investigational Site
    • Western Australia
      • 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
        • Amarin Investigational Site
  • Canada
      • Québec, Canada, G1V 4G5
        • Amarin Investigational Site
      • Québec, Canada, G1V 4M6
        • Amarin Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T5A 4L8
        • Amarin Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3V9
        • Amarin Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Amarin Investigational Site
      • Vancouver, British Columbia, Canada, V6Z1Y6
        • Amarin Investigational Site
    • Ontario
      • 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
        • Amarin Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Amarin Investigational Site
      • Montreal, Quebec, Canada, H1T 1C8
        • Amarin Investigational Site
      • Montreal, Quebec, Canada, H3H 1A1
        • Amarin Investigational Site
      • Sherbrooke, Quebec, Canada, J1J 2E3
        • Amarin Investigational Site
      • St. Charles-Borromée, Quebec, Canada, J6E 6J2
        • Amarin Investigational Site
  • India
    • Andhra Pradesh
      • 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
    • Delhi
      • New Delhi, Delhi, India, 110025
        • Amarin Investigational Site
      • New Delhi, Delhi, India, 110060
        • Amarin Investigational Site
    • Karnataka
      • 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
    • Kerala
      • Kottayam, Kerala, India, 686016
        • Amarin Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 422055
        • Amarin Investigational Site
      • Nashik, Maharashtra, India, 422005
        • Amarin Investigational Site
      • Pune, Maharashtra, India, 411004
        • Amarin Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Amarin Investigational Site
      • Coimbatore, Tamil Nadu, India, 641037
        • Amarin Investigational Site
  • Netherlands
      • 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
      • 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
        • Amarin Investigational Site
      • s'Hertogenbosch, Netherlands, 5223 GV
        • Amarin Investigational Site
  • New Zealand
      • 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
        • Amarin Investigational Site
    • Auckland
      • Takapuna, Auckland, New Zealand, 0622
        • Amarin Investigational Site
  • Poland
      • 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
        • Amarin Investigational Site
  • Romania
      • 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
        • Amarin Investigational Site
  • Russian Federation
      • 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
        • Amarin Investigational Site
  • South Africa
    • Freestate
      • Bloemfontein, Freestate, South Africa, 9301
        • Amarin Investigational Site
    • Gauteng
      • Benoni, Gauteng, South Africa, 1500
        • Amarin Investigational Site
      • Pretoria, Gauteng, South Africa, 0157
        • Amarin Investigational Site
      • Soweto, Gauteng, South Africa, 2013
        • Amarin Investigational Site
      • Witbank, Gauteng, South Africa, 1035
        • Amarin Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Amarin Investigational Site
      • Newlands, KwaZulu-Natal, South Africa, 4037
        • Amarin Investigational Site
    • Western Cape
      • 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
        • Amarin Investigational Site
  • Ukraine
      • 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
        • Amarin Investigational Site
    • Volyn Region
      • Lutsk, Volyn Region, Ukraine, 43000
        • Amarin Investigational Site
  • United States
    • Alabama
      • 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
        • Amarin Investigational Site
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Amarin Investigational Site
      • Phoenix, Arizona, United States, 85251
        • Amarin Investigational Site
      • Tucson, Arizona, United States, 85745
        • Amarin Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Amarin Investigational Site
    • California
      • 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
        • Amarin Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Amarin Investigational Site
      • Colorado Springs, Colorado, United States, 80909
        • Amarin Investigational Site
      • Golden, Colorado, United States, 80401
        • Amarin Investigational Site
    • Connecticut
      • Guilford, Connecticut, United States, 06437
        • Amarin Investigational Site
      • Hartford, Connecticut, United States, 06102
        • Amarin Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19718
        • Amarin Investigational Site
      • Wilmington, Delaware, United States, 19803
        • Amarin Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Amarin Investigational Site
    • Florida
      • 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, 32205
        • Amarin Investigational Site
      • Jacksonville, Florida, United States, 32204
        • Amarin Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Amarin Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Amarin Investigational Site
      • Miami, Florida, United States, 33144
        • Amarin Investigational Site
      • Miami, Florida, United States, 33175
        • Amarin Investigational Site
      • Miami Beach, Florida, United States, 33140
        • Amarin Investigational Site
      • Miami Lakes, Florida, United States, 33014
        • 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
      • Saint Petersburg, Florida, United States, 33713
        • Amarin Investigational Site
      • Sarasota, Florida, United States, 34233
        • Amarin Investigational Site
      • Vero Beach, Florida, United States, 32960
        • Amarin Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Amarin Investigational Site
    • Georgia
      • 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
        • Amarin Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96818
        • Amarin Investigational Site
    • Illinois
      • 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
        • Amarin Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Amarin Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Amarin Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67203
        • Amarin Investigational Site
      • Wichita, Kansas, United States, 67207
        • Amarin Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Amarin Investigational Site
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Amarin Investigational Site
      • Eunice, Louisiana, United States, 70535
        • Amarin Investigational Site
      • Marrero, Louisiana, United States, 70072
        • Amarin Investigational Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Amarin Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Amarin Investigational Site
      • Lutherville, Maryland, United States, 21093
        • Amarin Investigational Site
      • Takoma Park, Maryland, United States, 20912
        • Amarin Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Amarin Investigational Site
      • Boston, Massachusetts, United States, 02215
        • Amarin Investigational Site
      • Fall River, Massachusetts, United States, 02721
        • Amarin Investigational Site
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Amarin Investigational Site
      • Marquette, Michigan, United States, 49855
        • Amarin Investigational Site
      • Troy, Michigan, United States, 48098
        • Amarin Investigational Site
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56303
        • Amarin Investigational Site
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
        • Amarin Investigational Site
      • Tupelo, Mississippi, United States, 38801
        • Amarin Investigational Site
    • Missouri
      • 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
      • Saint Louis, Missouri, United States, 63110
        • Amarin Investigational Site
      • Saint Peters, Missouri, United States, 63303
        • Amarin Investigational Site
    • Nebraska
      • Hastings, Nebraska, United States, 68901
        • Amarin Investigational Site
      • Omaha, Nebraska, United States, 68114
        • Amarin Investigational Site
      • Omaha, Nebraska, United States, 68154
        • Amarin Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Amarin Investigational Site
      • Las Vegas, Nevada, United States, 89101
        • Amarin Investigational Site
    • New Jersey
      • Ocean City, New Jersey, United States, 07712
        • Amarin Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Amarin Investigational Site
    • New York
      • 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
        • Amarin Investigational Site
    • North Carolina
      • 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
        • Amarin Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Amarin Investigational Site
    • Ohio
      • 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
        • Amarin Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Amarin Investigational Site
    • Oregon
      • Bend, Oregon, United States, 97702
        • Amarin Investigational Site
      • Portland, Oregon, United States, 97239
        • Amarin Investigational Site
    • Pennsylvania
      • 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
        • Amarin Investigational Site
    • South Carolina
      • Lancaster, South Carolina, United States, 29720
        • Amarin Investigational Site
      • Simpsonville, South Carolina, United States, 29681
        • Amarin Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Amarin Investigational Site
    • Tennessee
      • 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
        • Amarin Investigational Site
    • Texas
      • 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, 77030
        • Amarin Investigational Site
      • Houston, Texas, United States, 77024
        • Amarin Investigational Site
      • Houston, Texas, United States, 77025
        • 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
        • Amarin Investigational Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • Amarin Investigational Site
    • Virginia
      • 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
        • Amarin Investigational Site
    • Washington
      • Burien, Washington, United States, 98166
        • Amarin Investigational Site
      • Tacoma, Washington, United States, 98405
        • Amarin Investigational Site
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Amarin Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

    • PCSK9 inhibitors
    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AMR101
AMR101 (icosapent ethyl) + statin therapy, daily
Drug: AMR101
Parallel Assignment
Other Names:
  • VASCEPA® (icosapent ethyl)
Drug: Statin therapy
Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C >40 mg/dL and ≤100 mg/dL)
PLACEBO_COMPARATOR: Placebo
Placebo + statin therapy, daily
Drug: Placebo
Parallel Assignment
Other Names:
  • matching placebo
Drug: Statin therapy
Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C >40 mg/dL and ≤100 mg/dL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.
Time Frame: Total follow-up time of up to approximately 6 years.
The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.
Total follow-up time of up to approximately 6 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
Time Frame: Total follow-up time of up to approximately 6 years.
The key secondary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.
Total follow-up time of up to approximately 6 years.
Composite of CV Death or Nonfatal MI (Including Silent MI).
Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with a first occurrence of any component of the composite of CV death or nonfatal MI (including silent MI) during the follow-up period.
Total follow-up time of up to approximately 6 years.
Fatal or Nonfatal MI (Including Silent MI).
Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with a first occurrence of fatal or nonfatal MI (including silent MI) during the follow-up period.
Total follow-up time of up to approximately 6 years.
Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.
Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with a first occurrence of non-elective coronary revascularization represented as the composite of emergent or urgent classifications during the follow-up period.
Total follow-up time of up to approximately 6 years.
CV Death.
Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with an occurrence of CV death during the follow-up period.
Total follow-up time of up to approximately 6 years.
Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.
Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with a first occurrence of unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.
Total follow-up time of up to approximately 6 years.
Fatal or Nonfatal Stroke.
Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with a first occurrence of fatal or nonfatal stroke during the follow-up period.
Total follow-up time of up to approximately 6 years.
Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with a first occurrence of any component of the composite of total mortality, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.
Total follow-up time of up to approximately 6 years.
Total Mortality.
Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with an occurrence of death from any cause during the follow-up period.
Total follow-up time of up to approximately 6 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amarin Pharma Inc.

Investigators

  • Principal Investigator: Deepak L. Bhatt, MD, MPH, Brigham and Women's Hospital, 75 Francis Street, Boston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2011

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 13, 2011

First Posted (ESTIMATE)

December 15, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMR-01-01-0019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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