AzTrials
AzTrials

Cardiovascular DiseasesPhase 3REDUCE-ITNCT01492361

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

A Phase 3 study testing AMR101 and Statin therapy in people with Cardiovascular Diseases, run by Amarin Pharma Inc. at 410 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Cardiovascular Diseases
What is being tested?
AMR101 and Statin therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,179 participants
Where
410 sitesin 11 countries
Study dates
Nov 2011to May 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

410 sites in 11 countries.

410 sites in 11 countries

United States176 sites

  • Amarin Investigational Site

    Addison, Illinois, 60101

  • Amarin Investigational Site

    Albany, New York, 12206

  • Amarin Investigational Site

    Albuquerque, New Mexico, 87102

  • Amarin Investigational Site

    Alexandria, Louisiana, 71301

  • Amarin Investigational Site

    Auburn, Maine, 04210

  • Amarin Investigational Site

    Aurora, Colorado, 80012

  • Amarin Investigational Site

    Austin, Texas, 78756

  • Amarin Investigational Site

    Baltimore, Maryland, 21236

  • Amarin Investigational Site

    Beaumont, Texas, 77702

  • Amarin Investigational Site

    Beaver, Pennsylvania, 15009

  • Amarin Investigational Site

    Bend, Oregon, 97702

  • Amarin Investigational Site

    Beverly Hills, California, 90211

  • Amarin Investigational Site

    Biloxi, Mississippi, 39531

  • Amarin Investigational Site

    Birmingham, Alabama, 35205

  • Amarin Investigational Site

    Birmingham, Alabama, 35235

  • Amarin Investigational Site

    Boston, Massachusetts, 02118

  • Amarin Investigational Site

    Boston, Massachusetts, 02215

  • Amarin Investigational Site

    Boynton Beach, Florida, 33437

  • Amarin Investigational Site

    Bradenton, Florida, 34209

  • Amarin Investigational Site

    Bristol, Tennessee, 37620

  • Amarin Investigational Site

    Brooklyn, New York, 11206

  • Amarin Investigational Site

    Burien, Washington, 98166

  • Amarin Investigational Site

    Carrollton, Texas, 75007

  • Amarin Investigational Site

    Charlotte, North Carolina, 28204

  • Amarin Investigational Site

    Chesterfield, Missouri, 63141

  • Amarin Investigational Site

    Chicago, Illinois, 60611

  • Amarin Investigational Site

    Chino, California, 91710

  • Amarin Investigational Site

    Cincinnati, Ohio, 45219

  • Amarin Investigational Site

    City of Saint Peters, Missouri, 63303

  • Amarin Investigational Site

    Clearwater, Florida, 33756

  • Amarin Investigational Site

    Colorado Springs, Colorado, 80909

  • Amarin Investigational Site

    Columbia, Tennessee, 38401

  • Amarin Investigational Site

    Concord, California, 94520

  • Amarin Investigational Site

    Conyers, Georgia, 30094

  • Amarin Investigational Site

    Covington, Georgia, 30014

  • Amarin Investigational Site

    Cumming, Georgia, 30041

  • Amarin Investigational Site

    Dallas, Texas, 75231

  • Amarin Investigational Site

    Dayton, Ohio, 45419

  • Amarin Investigational Site

    Doylestown, Pennsylvania, 18901

  • Amarin Investigational Site

    Durham, North Carolina, 27710

  • Amarin Investigational Site

    Edgewater, Florida, 32132

  • Amarin Investigational Site

    El Cajon, California, 92020

  • Amarin Investigational Site

    Encino, California, 91436

  • Amarin Investigational Site

    Eunice, Louisiana, 70535

  • Amarin Investigational Site

    Evansville, Indiana, 47713

  • Amarin Investigational Site

    Fair Oaks, California, 95628

  • Amarin Investigational Site

    Fall River, Massachusetts, 02721

  • Amarin Investigational Site

    Falls Church, Virginia, 22044

  • Amarin Investigational Site

    Fargo, North Dakota, 58103

  • Amarin Investigational Site

    Fleming Island, Florida, 32003

  • Amarin Investigational Site

    Florissant, Missouri, 63031

  • Amarin Investigational Site

    Fort Lauderdale, Florida, 33308

  • Amarin Investigational Site

    Fort Lauderdale, Florida, 33312

  • Amarin Investigational Site

    Gastonia, North Carolina, 28054

  • Amarin Investigational Site

    Germantown, Tennessee, 38138

  • Amarin Investigational Site

    Golden, Colorado, 80401

  • Amarin Investigational Site

    Great Neck, New York, 11023

  • Amarin Investigational Site

    Guilford, Connecticut, 06437

  • Amarin Investigational Site

    Hartford, Connecticut, 06102

  • Amarin Investigational Site

    Hastings, Nebraska, 68901

  • Amarin Investigational Site

    Hawaiian Gardens, California, 90716

  • Amarin Investigational Site

    Henderson, Nevada, 89052

  • Amarin Investigational Site

    Honolulu, Hawaii, 96818

  • Amarin Investigational Site

    Houston, Texas, 77024

  • Amarin Investigational Site

    Houston, Texas, 77025

  • Amarin Investigational Site

    Houston, Texas, 77030

  • Amarin Investigational Site

    Houston, Texas, 77053

  • Amarin Investigational Site

    Houston, Texas, 77070

  • Amarin Investigational Site

    Houston, Texas, 77077

  • Amarin Investigational Site

    Houston, Texas, 77079

  • Amarin Investigational Site

    Huntington, West Virginia, 25701

  • Amarin Investigational Site

    Huntsville, Alabama, 35801

  • Amarin Investigational Site

    Hurst, Texas, 76054

  • Amarin Investigational Site

    Inverness, Florida, 34429

  • Amarin Investigational Site

    Iowa City, Iowa, 52242

  • Amarin Investigational Site

    Jackson, Tennessee, 38301

  • Amarin Investigational Site

    Jacksonville, Florida, 32204

  • Amarin Investigational Site

    Jacksonville, Florida, 32205

  • Amarin Investigational Site

    Jacksonville, Florida, 32207

  • Amarin Investigational Site

    Jacksonville, Florida, 32216

  • Amarin Investigational Site

    Jefferson City, Missouri, 65109

  • Amarin Investigational Site

    Jersey Shore, Pennsylvania, 17740

  • Amarin Investigational Site

    Kansas City, Missouri, 64114

  • Amarin Investigational Site

    Kernersville, North Carolina, 27284

  • Amarin Investigational Site

    Knoxville, Tennessee, 37917

  • Amarin Investigational Site

    Lancaster, California, 93534

  • Amarin Investigational Site

    Lancaster, South Carolina, 29720

  • Amarin Investigational Site

    Lansing, Michigan, 48910

  • Amarin Investigational Site

    Las Vegas, Nevada, 89101

  • Amarin Investigational Site

    Lincoln, California, 95648

  • Amarin Investigational Site

    Little Rock, Arkansas, 72204

  • Amarin Investigational Site

    Liverpool, New York, 13088

  • Amarin Investigational Site

    Lorain, Ohio, 44053

  • Amarin Investigational Site

    Los Angeles, California, 90015

  • Amarin Investigational Site

    Los Angeles, California, 90017

  • Amarin Investigational Site

    Los Angeles, California, 90033

  • Amarin Investigational Site

    Louisville, Kentucky, 40213

  • Amarin Investigational Site

    Lutherville, Maryland, 21093

  • Amarin Investigational Site

    Manassas, Virginia, 20109

  • Amarin Investigational Site

    Marquette, Michigan, 49855

  • Amarin Investigational Site

    Marrero, Louisiana, 70072

  • Amarin Investigational Site

    Mesa, Arizona, 85206

  • Amarin Investigational Site

    Miami, Florida, 33144

  • Amarin Investigational Site

    Miami, Florida, 33175

  • Amarin Investigational Site

    Miami Beach, Florida, 33140

  • Amarin Investigational Site

    Miami Lakes, Florida, 33014

  • Amarin Investigational Site

    Midlothian, Virginia, 23114

  • Amarin Investigational Site

    Mobile, Alabama, 36608

  • Amarin Investigational Site

    Muscle Shoals, Alabama, 35662

  • Amarin Investigational Site

    National City, California, 91950

  • Amarin Investigational Site

    New Braunfels, Texas, 78130

  • Amarin Investigational Site

    New York, New York, 10001

  • Amarin Investigational Site

    New York, New York, 10016

  • Amarin Investigational Site

    Newark, Delaware, 19718

  • Amarin Investigational Site

    Newport, Pennsylvania, 17074

  • Amarin Investigational Site

    Newport News, Virginia, 23606

  • Amarin Investigational Site

    Norman, Illinois, 61761

  • Amarin Investigational Site

    North Chicago, Illinois, 60064

  • Amarin Investigational Site

    North Massapequa, New York, 11758

  • Amarin Investigational Site

    Ocala, Florida, 34471

  • Amarin Investigational Site

    Ocean City, New Jersey, 07712

  • Amarin Investigational Site

    Omaha, Nebraska, 68114

  • Amarin Investigational Site

    Omaha, Nebraska, 68154

  • Amarin Investigational Site

    Orange, California, 92868

  • Amarin Investigational Site

    Orlando, Florida, 32803

  • Amarin Investigational Site

    Paramount, California, 90723

  • Amarin Investigational Site

    Pembroke Pines, Florida, 33026

  • Amarin Investigational Site

    Peoria, Illinois, 61636

  • Amarin Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Amarin Investigational Site

    Phoenix, Arizona, 85251

  • Amarin Investigational Site

    Phoenixville, Pennsylvania, 19460

  • Amarin Investigational Site

    Plano, Texas, 75075

  • Amarin Investigational Site

    Plantation, Florida, 33324

  • Amarin Investigational Site

    Portland, Oregon, 97239

  • Amarin Investigational Site

    Raleigh, North Carolina, 27609

  • Amarin Investigational Site

    Rapid City, South Dakota, 57701

  • Amarin Investigational Site

    Roseville, California, 95661

  • Amarin Investigational Site

    Roswell, Georgia, 30076

  • Amarin Investigational Site

    Safety Harbor, Florida, 34695

  • Amarin Investigational Site

    Saint Cloud, Minnesota, 56303

  • Amarin Investigational Site

    San Antonio, Texas, 78228

  • Amarin Investigational Site

    San Antonio, Texas, 78238

  • Amarin Investigational Site

    San Diego, California, 92123

  • Amarin Investigational Site

    Sandusky, Ohio, 44870

  • Amarin Investigational Site

    Sarasota, Florida, 34233

  • Amarin Investigational Site

    Sellersville, Pennsylvania, 18960

  • Amarin Investigational Site

    Simpsonville, South Carolina, 29681

  • Amarin Investigational Site

    Smithtown, New York, 11787

  • Amarin Investigational Site

    Smyrna, Tennessee, 37167

  • Amarin Investigational Site

    Splendora, Texas, 77372

  • Amarin Investigational Site

    St Louis, Missouri, 63110

  • Amarin Investigational Site

    St. Petersburg, Florida, 33713

  • Amarin Investigational Site

    Tacoma, Washington, 98405

  • Amarin Investigational Site

    Takoma Park, Maryland, 20912

  • Amarin Investigational Site

    Tipton, Pennsylvania, 16684

  • Amarin Investigational Site

    Tomball, Texas, 77375

  • Amarin Investigational Site

    Torrance, California, 90502

  • Amarin Investigational Site

    Troy, Michigan, 48098

  • Amarin Investigational Site

    Tucson, Arizona, 85745

  • Amarin Investigational Site

    Tulsa, Oklahoma, 74104

  • Amarin Investigational Site

    Tupelo, Mississippi, 38801

  • Amarin Investigational Site

    Ventura, California, 93003

  • Amarin Investigational Site

    Vero Beach, Florida, 32960

  • Amarin Investigational Site

    Vestal, New York, 13850

  • Amarin Investigational Site

    Walnut Creek, California, 94598

  • Amarin Investigational Site

    Washington D.C., District of Columbia, 20037

  • Amarin Investigational Site

    West Jordan, Utah, 84088

  • Amarin Investigational Site

    West Palm Beach, Florida, 33401

  • Amarin Investigational Site

    West Seneca, New York, 14224

  • Amarin Investigational Site

    Wichita, Kansas, 67203

  • Amarin Investigational Site

    Wichita, Kansas, 67207

  • Amarin Investigational Site

    Wilmington, Delaware, 19803

  • Amarin Investigational Site

    Winfield, Illinois, 60190

  • Amarin Investigational Site

    Winston-Salem, North Carolina, 27157

  • Amarin Investigational Site

    Wyomissing, Pennsylvania, 19610

  • Amarin Investigational Site

    Yardley, Pennsylvania, 19067

Other trials in United States

Russia52 sites

  • Amarin Investigational Site

    Arkhangelsk, 163000

  • Amarin Investigational Site

    Arkhangelsk, 163001

  • Amarin Investigational Site

    Arkhangelsk, 163045

  • Amarin Investigational Site

    Kazan', 420012

  • Amarin Investigational Site

    Kazan', 420097

  • Amarin Investigational Site

    Kemerovo, 650000

  • Amarin Investigational Site

    Kemerovo, 650002

  • Amarin Investigational Site

    Kirovsk, Leningradskaya Region, 187342

  • Amarin Investigational Site

    Krasnodar, 350086

  • Amarin Investigational Site

    Moscow, 109240

  • Amarin Investigational Site

    Moscow, 111020

  • Amarin Investigational Site

    Moscow, 111539

  • Amarin Investigational Site

    Moscow, 115093

  • Amarin Investigational Site

    Moscow, 117292

  • Amarin Investigational Site

    Moscow, 117593

  • Amarin Investigational Site

    Moscow, 117630

  • Amarin Investigational Site

    Moscow, 117997

  • Amarin Investigational Site

    Moscow, 121374

  • Amarin Investigational Site

    Moscow, 121552

  • Amarin Investigational Site

    Moscow, 124489

  • Amarin Investigational Site

    Nizhny Novgorod, 603126

  • Amarin Investigational Site

    Novosibirsk, 630008

  • Amarin Investigational Site

    Novosibirsk, 630047

  • Amarin Investigational Site

    Novosibirsk, 630089

  • Amarin Investigational Site

    Petrozavodsk, 185000

  • Amarin Investigational Site

    Saint Petersburg, 190000

  • Amarin Investigational Site

    Saint Petersburg, 190107

  • Amarin Investigational Site

    Saint Petersburg, 192283

  • Amarin Investigational Site

    Saint Petersburg, 194044

  • Amarin Investigational Site

    Saint Petersburg, 194156

  • Amarin Investigational Site

    Saint Petersburg, 194291

  • Amarin Investigational Site

    Saint Petersburg, 194354

  • Amarin Investigational Site

    Saint Petersburg, 196601

  • Amarin Investigational Site

    Saint Petersburg, 197022

  • Amarin Investigational Site

    Saint Petersburg, 197110

  • Amarin Investigational Site

    Saint Petersburg, 197227

  • Amarin Investigational Site

    Saint Petersburg, 197341

  • Amarin Investigational Site

    Saint Petersburg, 197729

  • Amarin Investigational Site

    Saint Petersburg, 198205

  • Amarin Investigational Site

    Saint Petersburg, 199106

  • Amarin Investigational Site

    Saratov, 410002

  • Amarin Investigational Site

    Saratov, 410028

  • Amarin Investigational Site

    Sestroretsk, Saint-Petersburg, 197706

  • Amarin Investigational Site

    Tomsk, 634050

  • Amarin Investigational Site

    Tomsk, 643012

  • Amarin Investigational Site

    Volgograd, 400001

  • Amarin Investigational Site

    Voronezh, 394018

  • Amarin Investigational Site

    Voronezh, 394065

  • Amarin Investigational Site

    Yaroslavl, 150030

  • Amarin Investigational Site

    Yaroslavl, 150062

  • Amarin Investigational Site

    Yekaterinburg, 620102

  • Amarin Investigational Site

    Yekaterinburg, 620109

Other trials in Russia

Ukraine39 sites

  • Amarin Investigational Site

    Cherkasy, 18009

  • Amarin Investigational Site

    Chernivtsi, 58002

  • Amarin Investigational Site

    Dnipropetrovsk, 49006

  • Amarin Investigational Site

    Dnipropetrovsk, 49023

  • Amarin Investigational Site

    Dnipropetrovsk, 49027

  • Amarin Investigational Site

    Donetsk, 83001

  • Amarin Investigational Site

    Donetsk, 83045

  • Amarin Investigational Site

    Ivano-Frankivsk, 76005

  • Amarin Investigational Site

    Ivano-Frankivsk, 76018

  • Amarin Investigational Site

    Kharkiv, 61002

  • Amarin Investigational Site

    Kharkiv, 61018

  • Amarin Investigational Site

    Kharkiv, 61039

  • Amarin Investigational Site

    Kharkiv, 61176

  • Amarin Investigational Site

    Kyiv, 01032

  • Amarin Investigational Site

    Kyiv, 01103

  • Amarin Investigational Site

    Kyiv, 01151

  • Amarin Investigational Site

    Kyiv, 01601

  • Amarin Investigational Site

    Kyiv, 02091

  • Amarin Investigational Site

    Kyiv, 02660

  • Amarin Investigational Site

    Kyiv, 03151

  • Amarin Investigational Site

    Kyiv, 04050

  • Amarin Investigational Site

    Kyiv, 04114

  • Amarin Investigational Site

    Luhansk, 91016

  • Amarin Investigational Site

    Lutsk, Volyn Oblast, 43000

  • Amarin Investigational Site

    Lutsk, 43024

  • Amarin Investigational Site

    Lviv, 79034

  • Amarin Investigational Site

    Odesa, 65009

  • Amarin Investigational Site

    Odesa, 65025

  • Amarin Investigational Site

    Odesa, 65082

  • Amarin Investigational Site

    Poltava, 36011

  • Amarin Investigational Site

    Ternopil, 46003

  • Amarin Investigational Site

    Uzhhorod, 88000

  • Amarin Investigational Site

    Uzhhorod, 88014

  • Amarin Investigational Site

    Vinnytsia, 21018

  • Amarin Investigational Site

    Vinnytsia, 21029

  • Amarin Investigational Site

    Zaporizhzhya, 69035

  • Amarin Investigational Site

    Zaporizhzhya, 69065

  • Amarin Investigational Site

    Zaporizhzhya, 69106

  • Amarin Investigational Site

    Zaporizhzhya, 69600

Other trials in Ukraine

Netherlands35 sites

  • Amarin Investigational Site

    Almelo, 7600 SZ

  • Amarin Investigational Site

    Amersfoort, 3813 TZ

  • Amarin Investigational Site

    Blaricum, 1261 AN

  • Amarin Investigational Site

    Capelle aan den IJssel, 2906 ZC

  • Amarin Investigational Site

    Den Helder, 1782 GZ

  • Amarin Investigational Site

    Deventer, 7416 SE

  • Amarin Investigational Site

    Ede, 6716 RP

  • Amarin Investigational Site

    Eindhoven, 5611 NV

  • Amarin Investigational Site

    Enschede, 7513 ER

  • Amarin Investigational Site

    Goes, 4462 RA

  • Amarin Investigational Site

    Gorinchem, 4204 AA

  • Amarin Investigational Site

    Gouda, 2803 HH

  • Amarin Investigational Site

    Groningen, 9728 NT

  • Amarin Investigational Site

    Haarlem, 2035 RC

  • Amarin Investigational Site

    Harderwijk, 3844 DG

  • Amarin Investigational Site

    Heerenveen, 8441 PW

  • Amarin Investigational Site

    Heerlen, 6419 PC

  • Amarin Investigational Site

    Hoofddorp, 2134 TM

  • Amarin Investigational Site

    Leeuwarden, 8934 AD

  • Amarin Investigational Site

    Leiderdorp, 2353 GA

  • Amarin Investigational Site

    Nijmegen, 6532 SZ

  • Amarin Investigational Site

    Roosendaal, 4708 AE

  • Amarin Investigational Site

    Rotterdam, 3021 HC

  • Amarin Investigational Site

    Rotterdam, 3045 PM

  • Amarin Investigational Site

    Rotterdam, 3083 AN

  • Amarin Investigational Site

    s'Hertogenbosch, 5223 GV

  • Amarin Investigational Site

    Schiedam, 3118 JH

  • Amarin Investigational Site

    Sneek, 8601 ZK

  • Amarin Investigational Site

    The Hague, 2597 AX

  • Amarin Investigational Site

    Tilburg, 5022 GC

  • Amarin Investigational Site

    Tilburg, 5042 AD

  • Amarin Investigational Site

    Uden, 5406 PT

  • Amarin Investigational Site

    Veldhoven, 5504 DB

  • Amarin Investigational Site

    Zoetermeer, 2725 NA

  • Amarin Investigational Site

    Zutphen, 7207 AE

Other trials in Netherlands

South Africa18 sites

  • Amarin Investigational Site

    Bellville, Western Cape, 7530

  • Amarin Investigational Site

    Benoni, Gauteng, 1500

  • Amarin Investigational Site

    Bloemfontein, Freestate, 9301

  • Amarin Investigational Site

    Cape Town, Western Cape, 7925

  • Amarin Investigational Site

    Durban, KwaZulu-Natal, 4001

  • Amarin Investigational Site

    Durbanville, Western Cape, 7550

  • Amarin Investigational Site

    Goodwood, Western Cape, 7460

  • Amarin Investigational Site

    Kraaifontein, Western Cape, 7570

  • Amarin Investigational Site

    Newlands, KwaZulu-Natal, 4037

  • Amarin Investigational Site

    Paarl, Western Cape, 7646

  • Amarin Investigational Site

    Panorama, Western Cape, 7500

  • Amarin Investigational Site

    Parow, Western Cape, 7500

  • Amarin Investigational Site

    Pinelands, Western Cape, 7405

  • Amarin Investigational Site

    Pretoria, Gauteng, 0157

  • Amarin Investigational Site

    Somerset West, Western Cape, 7130

  • Amarin Investigational Site

    Soweto, Gauteng, 2013

  • Amarin Investigational Site

    Witbank, Gauteng, 1035

  • Amarin Investigational Site

    Worcester, Western Cape, 6850

Other trials in South Africa

Canada17 sites

  • Amarin Investigational Site

    Brampton, Ontario, L6Z 4N5

  • Amarin Investigational Site

    Collingwood, Ontario, L9Y 1W3

  • Amarin Investigational Site

    Coquitlam, British Columbia, V3K 3V9

  • Amarin Investigational Site

    Corunna, Ontario, N0N 1G0

  • Amarin Investigational Site

    Edmonton, Alberta, T5A 4L8

  • Amarin Investigational Site

    Laval, Quebec, H7T 2P5

  • Amarin Investigational Site

    Montreal, Quebec, H1T 1C8

  • Amarin Investigational Site

    Montreal, Quebec, H3H 1A1

  • Amarin Investigational Site

    Newmarket, Ontario, L3Y 5G8

  • Amarin Investigational Site

    Québec, G1V 4G5

  • Amarin Investigational Site

    Québec, G1V 4M6

  • Amarin Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • Amarin Investigational Site

    Sarnia, Ontario, N7T 4X3

  • Amarin Investigational Site

    Sherbrooke, Quebec, J1J 2E3

  • Amarin Investigational Site

    Strathroy, Ontario, N7G 1Y7

  • Amarin Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • Amarin Investigational Site

    Vancouver, British Columbia, V6Z1Y6

Other trials in Canada

India17 sites

  • Amarin Investigational Site

    Bangalore, Karnataka, 560034

  • Amarin Investigational Site

    Bangalore, Karnataka, 560038

  • Amarin Investigational Site

    Bangalore, Karnataka, 560052

  • Amarin Investigational Site

    Chennai, Tamil Nadu, 600086

  • Amarin Investigational Site

    Coimbatore, Tamil Nadu, 641037

  • Amarin Investigational Site

    Hyderabad, Andhra Pradesh, 500001

  • Amarin Investigational Site

    Hyderabad, Andhra Pradesh, 500004

  • Amarin Investigational Site

    Kottayam, Kerala, 686016

  • Amarin Investigational Site

    Mumbai, Maharashtra, 422055

  • Amarin Investigational Site

    Mysore, Karnataka, 570015

  • Amarin Investigational Site

    Mysore, Karnataka, 570020

  • Amarin Investigational Site

    Nashik, Maharashtra, 422005

  • Amarin Investigational Site

    New Delhi, National Capital Territory of Delhi, 110025

  • Amarin Investigational Site

    New Delhi, National Capital Territory of Delhi, 110060

  • Amarin Investigational Site

    Pune, Maharashtra, 411004

  • Amarin Investigational Site

    Secunderabad, Andhra Pradesh, 500003

  • Amarin Investigational Site

    Visakhapatnam, Andhra Pradesh, 530013

Other trials in India

Romania17 sites

  • Amarin Investigational Site

    Argeş, 110084

  • Amarin Investigational Site

    Brăila, 810249

  • Amarin Investigational Site

    Bucharest, 010628

  • Amarin Investigational Site

    Bucharest, 011234

  • Amarin Investigational Site

    Bucharest, 0200054

  • Amarin Investigational Site

    Bucharest, 050098

  • Amarin Investigational Site

    Bucharest, 050524

  • Amarin Investigational Site

    Bucharest, 061098

  • Amarin Investigational Site

    Cluj-Napoca, 400006

  • Amarin Investigational Site

    Constanța, 900203

  • Amarin Investigational Site

    Craiova, Dolj, 200030

  • Amarin Investigational Site

    Iași, 700661

  • Amarin Investigational Site

    Maramureş, 430123

  • Amarin Investigational Site

    Mureş, 540098

  • Amarin Investigational Site

    Sibiu, 550245

  • Amarin Investigational Site

    Târgu Mureş, 540136

  • Amarin Investigational Site

    Timișoara, 300359

Other trials in Romania

Australia15 sites

  • Amarin Investigational Site

    Bedford Park, South Australia, 5042

  • Amarin Investigational Site

    Brisbane, Queensland, 4064

  • Amarin Investigational Site

    Camperdown, New South Wales, 2015

  • Amarin Investigational Site

    Chermside, Queensland, 4032

  • Amarin Investigational Site

    Fitzroy, Victoria, 3065

  • Amarin Investigational Site

    Fremantle, Western Australia, 6160

  • Amarin Investigational Site

    Geelong, Victoria, 3220

  • Amarin Investigational Site

    Heidelberg Heights, Victoria, 3081

  • Amarin Investigational Site

    Joondalup, Western Australia, 6027

  • Amarin Investigational Site

    Launceston, Tasmania, 7250

  • Amarin Investigational Site

    Lismore, New South Wales, 2480

  • Amarin Investigational Site

    Melbourne, Victoria, 3004

  • Amarin Investigational Site

    Murdoch, Western Australia, 6150

  • Amarin Investigational Site

    Nedlands, Western Australia, 6009

  • Amarin Investigational Site

    Perth, Western Australia, 6000

Other trials in Australia

Poland14 sites

  • Amarin Investigational Site

    Bialystok, 15-351

  • Amarin Investigational Site

    Bialystok, 15-875

  • Amarin Investigational Site

    Katowice, 40-748

  • Amarin Investigational Site

    Katowice, 40-772

  • Amarin Investigational Site

    Krakow, 31-011

  • Amarin Investigational Site

    Mikolów, 43-190

  • Amarin Investigational Site

    Skierniewice, 96-100

  • Amarin Investigational Site

    Tarnów, 33-100

  • Amarin Investigational Site

    Warsaw, 01-231

  • Amarin Investigational Site

    Warsaw, 04-628

  • Amarin Investigational Site

    Warszawska, 01-192

  • Amarin Investigational Site

    Wroclaw, 50-088

  • Amarin Investigational Site

    Wroclaw, 50-315

  • Amarin Investigational Site

    Zgierz, 95-100

Other trials in Poland

New Zealand10 sites

  • Amarin Investigational Site

    Christchurch, 8011

  • Amarin Investigational Site

    Dunedin, 9016

  • Amarin Investigational Site

    Hamilton, 3240

  • Amarin Investigational Site

    Hastings, 4120

  • Amarin Investigational Site

    Nelson, 7010

  • Amarin Investigational Site

    New Plymouth, 4342

  • Amarin Investigational Site

    Takapuna, Auckland, 0622

  • Amarin Investigational Site

    Takapuna Auckland, 0622

  • Amarin Investigational Site

    Tauranga, 3112

  • Amarin Investigational Site

    Whangarei, 0110

Other trials in New Zealand

About this study

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)

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.

Being tested
AMR101, Placebo, Statin therapy
Keywords
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
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Acute Coronary Syndrome, Arteriosclerosis, Arterial Occlusive Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMR101Drug

    Also called VASCEPA® (icosapent ethyl)

    Parallel Assignment

  • PlaceboDrug

    Also called matching placebo

    Parallel Assignment

  • Statin therapyDrug

    Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C >40 mg/dL and ≤100 mg/dL)

Study groups in NCT01492361
Study groupRoleWhat they receive
AMR101ExperimentalAMR101 (icosapent ethyl) + statin therapy, daily
Receives: Drug: AMR101; Drug: Statin therapy
PlaceboPlacebo comparatorPlacebo + statin therapy, daily
Receives: Drug: Placebo; Drug: Statin therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: Total follow-up time of up to approximately 6 years.

Secondary outcomes (9)

  1. Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.

    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.

    Measured: Total follow-up time of up to approximately 6 years.

  2. Composite of CV Death or Nonfatal MI (Including Silent MI).

    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.

    Measured: Total follow-up time of up to approximately 6 years.

  3. Fatal or Nonfatal MI (Including Silent MI).

    Number of patients with a first occurrence of fatal or nonfatal MI (including silent MI) during the follow-up period.

    Measured: Total follow-up time of up to approximately 6 years.

  4. Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.

    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.

    Measured: Total follow-up time of up to approximately 6 years.

  5. CV Death.

    Number of patients with an occurrence of CV death during the follow-up period.

    Measured: Total follow-up time of up to approximately 6 years.

  6. Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.

    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.

    Measured: Total follow-up time of up to approximately 6 years.

  7. Fatal or Nonfatal Stroke.

    Number of patients with a first occurrence of fatal or nonfatal stroke during the follow-up period.

    Measured: Total follow-up time of up to approximately 6 years.

  8. Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.

    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.

    Measured: Total follow-up time of up to approximately 6 years.

  9. Total Mortality.

    Number of patients with an occurrence of death from any cause during the follow-up period.

    Measured: Total follow-up time of up to approximately 6 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMay 2018
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
8,179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01492361
Sponsor's protocol ID
AMR-01-01-0019
Acronym
REDUCE-IT
Status last verified
Mar 2022
First submitted
13 Dec 2011
Last updated
14 Apr 2022
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Bhatt DL, Steg PG, Brinton EA, Jacobson TA, Miller M, Tardif JC, Ketchum SB, Doyle RT Jr, Murphy SA, Soni PN, Braeckman RA, Juliano RA, Ballantyne CM; REDUCE-IT Investigators. Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial. Clin Cardiol. 2017 Mar;40(3):138-148. doi: 10.1002/clc.22692. Epub 2017 Mar 15.

    PubMed 28294373

  • Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. doi: 10.1056/NEJMoa1812792. Epub 2018 Nov 10.

    PubMed 30415628

  • Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Gregson J, Pocock SJ, Ballantyne CM; REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019 Jun 11;73(22):2791-2802. doi: 10.1016/j.jacc.2019.02.032. Epub 2019 Mar 18.

    PubMed 30898607

  • Bhatt DL, Miller M, Brinton EA, Jacobson TA, Steg PG, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Olshansky B, Chung MK, Gibson CM, Giugliano RP, Budoff MJ, Ballantyne CM; REDUCE-IT Investigators. REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States. Circulation. 2020 Feb 4;141(5):367-375. doi: 10.1161/CIRCULATIONAHA.119.044440. Epub 2019 Nov 11.

    PubMed 31707829

  • Olshansky B, Bhatt DL, Miller M, Steg PG, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Mehta C, Mukherjee R, Ballantyne CM, Chung MK; REDUCE-IT Investigators. REDUCE-IT INTERIM: accumulation of data across prespecified interim analyses to final results. Eur Heart J Cardiovasc Pharmacother. 2021 May 23;7(3):e61-e63. doi: 10.1093/ehjcvp/pvaa118. No abstract available.

    PubMed 33010162

  • Peterson BE, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Tardif JC, Verma S, Ballantyne CM; REDUCE-IT Investigators. Reduction in Revascularization With Icosapent Ethyl: Insights From REDUCE-IT Revascularization Analyses. Circulation. 2021 Jan 5;143(1):33-44. doi: 10.1161/CIRCULATIONAHA.120.050276. Epub 2020 Nov 5.

    PubMed 33148016

  • Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Jiao L, Tardif JC, Gregson J, Pocock SJ, Ballantyne CM; REDUCE-IT Investigators. Reduction in First and Total Ischemic Events With Icosapent Ethyl Across Baseline Triglyceride Tertiles. J Am Coll Cardiol. 2019 Aug 27;74(8):1159-1161. doi: 10.1016/j.jacc.2019.06.043. No abstract available.

    PubMed 31439224

  • Gaba P, Bhatt DL, Giugliano RP, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Tardif JC, Ballantyne CM, Pinto DS, Budoff MJ, Gibson CM. Comparative Reductions in Investigator-Reported and Adjudicated Ischemic Events in REDUCE-IT. J Am Coll Cardiol. 2021 Oct 12;78(15):1525-1537. doi: 10.1016/j.jacc.2021.08.009.

    PubMed 34620410

  • Majithia A, Bhatt DL, Friedman AN, Miller M, Steg PG, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Budoff M, Preston Mason R, Tardif JC, Boden WE, Ballantyne CM. Benefits of Icosapent Ethyl Across the Range of Kidney Function in Patients With Established Cardiovascular Disease or Diabetes: REDUCE-IT RENAL. Circulation. 2021 Nov 30;144(22):1750-1759. doi: 10.1161/CIRCULATIONAHA.121.055560. Epub 2021 Oct 28.

    PubMed 34706555

  • Verma S, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Dhingra NK, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Mason RP, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Icosapent Ethyl Reduces Ischemic Events in Patients With a History of Previous Coronary Artery Bypass Grafting: REDUCE-IT CABG. Circulation. 2021 Dec 7;144(23):1845-1855. doi: 10.1161/CIRCULATIONAHA.121.056290. Epub 2021 Oct 28.

    PubMed 34710343

  • Singh N, Bhatt DL, Miller M, Steg PG, Brinton EA, Jacobson TA, Jiao L, Tardif JC, Mason RP, Ballantyne CM; REDUCE-IT Investigators. Consistency of Benefit of Icosapent Ethyl by Background Statin Type in REDUCE-IT. J Am Coll Cardiol. 2022 Jan 18;79(2):220-222. doi: 10.1016/j.jacc.2021.11.005. No abstract available.

    PubMed 35027114

  • Gurevitz C, Bhatt DL, Giugliano RP, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Lira Pineda A, Doyle RT Jr, Giugliano G, Mason RP, Tardif JC, Martens FMAC, Ballantyne CM, Budoff MJ, Gibson CM. Benefit of Icosapent Ethyl Across Types and Sizes of Myocardial Infarction in REDUCE-IT. Eur J Prev Cardiol. 2025 Sep 22:zwaf602. doi: 10.1093/eurjpc/zwaf602. Online ahead of print.

    PubMed 40982548

  • Aggarwal R, Bhatt DL, Steg PG, Miller M, Brinton EA, Dunbar RL, Ketchum SB, Tardif JC, Martens FMAC, Ballantyne CM, Szarek M, Mason RP; REDUCE-IT Investigators. Cardiovascular Outcomes With Icosapent Ethyl by Baseline Low-Density Lipoprotein Cholesterol: A Secondary Analysis of the REDUCE-IT Randomized Trial. J Am Heart Assoc. 2025 Mar 4;14(5):e038656. doi: 10.1161/JAHA.124.038656. Epub 2025 Feb 19.

    PubMed 39968782

  • Weintraub WS, Bhatt DL, Zhang Z, Dolman S, Boden WE, Bress AP, Bellows BK, Derington CG, Philip S, Steg G, Miller M, Brinton EA, Jacobson TA, Tardif JC, Ballantyne CM, Kolm P. Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT USA: Results From Patients Randomized in the United States. J Am Heart Assoc. 2024 Jan 2;13(1):e032413. doi: 10.1161/JAHA.123.032413. Epub 2023 Dec 29.

    PubMed 38156550

  • Miller M, Bhatt DL, Brinton EA, Jacobson TA, Steg PG, Pineda AL, Ketchum SB, Doyle RT Jr, Tardif JC, Ballantyne CM. Effectiveness of icosapent ethyl on first and total cardiovascular events in patients with metabolic syndrome, but without diabetes: REDUCE-IT MetSyn. Eur Heart J Open. 2023 Nov 12;3(6):oead114. doi: 10.1093/ehjopen/oead114. eCollection 2023 Nov.

    PubMed 38035037

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AMR101 and Statin therapy in people with Cardiovascular Diseases, run by Amarin Pharma Inc. at 410 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 410 sites in United States, Russia, Ukraine, Netherlands, South Africa and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01492361, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.

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