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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01492361

Public ClinicalTrials.gov record NCT01492361. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 6:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01492361
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amarin Pharma Inc.
Industry
Enrollment
8,179 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
45 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2011 (Actual)
Primary completion
May 2018 (Actual)
Completion
May 2018 (Actual)
Last update posted
Apr 14, 2022

2011 – 2018

United States locations

U.S. sites
176
U.S. states
43
U.S. cities
157
Facility City State ZIP Site status
Amarin Investigational Site Birmingham Alabama 35205 —
Amarin Investigational Site Birmingham Alabama 35235 —
Amarin Investigational Site Huntsville Alabama 35801 —
Amarin Investigational Site Mobile Alabama 36608 —
Amarin Investigational Site Muscle Shoals Alabama 35662 —
Amarin Investigational Site Mesa Arizona 85206 —
Amarin Investigational Site Phoenix Arizona 85251 —
Amarin Investigational Site Tucson Arizona 85745 —
Amarin Investigational Site Little Rock Arkansas 72204 —
Amarin Investigational Site Beverly Hills California 90211 —
Amarin Investigational Site Chino California 91710 —
Amarin Investigational Site Concord California 94520 —
Amarin Investigational Site El Cajon California 92020 —
Amarin Investigational Site Encino California 91436 —
Amarin Investigational Site Fair Oaks California 95628 —
Amarin Investigational Site Hawaiian Gardens California 90716 —
Amarin Investigational Site Lancaster California 93534 —
Amarin Investigational Site Lincoln California 95648 —
Amarin Investigational Site Los Angeles California 90015 —
Amarin Investigational Site Los Angeles California 90017 —
Amarin Investigational Site Los Angeles California 90033 —
Amarin Investigational Site National City California 91950 —
Amarin Investigational Site Orange California 92868 —
Amarin Investigational Site Paramount California 90723 —
Amarin Investigational Site Roseville California 95661 —
Amarin Investigational Site San Diego California 92123 —
Amarin Investigational Site Torrance California 90502 —
Amarin Investigational Site Ventura California 93003 —
Amarin Investigational Site Walnut Creek California 94598 —
Amarin Investigational Site Aurora Colorado 80012 —
Amarin Investigational Site Colorado Springs Colorado 80909 —
Amarin Investigational Site Golden Colorado 80401 —
Amarin Investigational Site Guilford Connecticut 06437 —
Amarin Investigational Site Hartford Connecticut 06102 —
Amarin Investigational Site Newark Delaware 19718 —
Amarin Investigational Site Wilmington Delaware 19803 —
Amarin Investigational Site Washington D.C. District of Columbia 20037 —
Amarin Investigational Site Boynton Beach Florida 33437 —
Amarin Investigational Site Bradenton Florida 34209 —
Amarin Investigational Site Clearwater Florida 33756 —
Amarin Investigational Site Edgewater Florida 32132 —
Amarin Investigational Site Fleming Island Florida 32003 —
Amarin Investigational Site Fort Lauderdale Florida 33308 —
Amarin Investigational Site Fort Lauderdale Florida 33312 —
Amarin Investigational Site Inverness Florida 34429 —
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 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 Ocala Florida 34471 —
Amarin Investigational Site Orlando Florida 32803 —
Amarin Investigational Site Pembroke Pines Florida 33026 —
Amarin Investigational Site Plantation Florida 33324 —
Amarin Investigational Site Safety Harbor Florida 34695 —
Amarin Investigational Site Sarasota Florida 34233 —
Amarin Investigational Site St. Petersburg Florida 33713 —
Amarin Investigational Site Vero Beach Florida 32960 —
Amarin Investigational Site West Palm Beach Florida 33401 —
Amarin Investigational Site Conyers Georgia 30094 —
Amarin Investigational Site Covington Georgia 30014 —
Amarin Investigational Site Cumming Georgia 30041 —
Amarin Investigational Site Roswell Georgia 30076 —
Amarin Investigational Site Honolulu Hawaii 96818 —
Amarin Investigational Site Addison Illinois 60101 —
Amarin Investigational Site Chicago Illinois 60611 —
Amarin Investigational Site Norman Illinois 61761 —
Amarin Investigational Site North Chicago Illinois 60064 —
Amarin Investigational Site Peoria Illinois 61636 —
Amarin Investigational Site Winfield Illinois 60190 —
Amarin Investigational Site Evansville Indiana 47713 —
Amarin Investigational Site Iowa City Iowa 52242 —
Amarin Investigational Site Wichita Kansas 67203 —
Amarin Investigational Site Wichita Kansas 67207 —
Amarin Investigational Site Louisville Kentucky 40213 —
Amarin Investigational Site Alexandria Louisiana 71301 —
Amarin Investigational Site Eunice Louisiana 70535 —
Amarin Investigational Site Marrero Louisiana 70072 —
Amarin Investigational Site Auburn Maine 04210 —
Amarin Investigational Site Baltimore Maryland 21236 —
Amarin Investigational Site Lutherville Maryland 21093 —
Amarin Investigational Site Takoma Park Maryland 20912 —
Amarin Investigational Site Boston Massachusetts 02118 —
Amarin Investigational Site Boston Massachusetts 02215 —
Amarin Investigational Site Fall River Massachusetts 02721 —
Amarin Investigational Site Lansing Michigan 48910 —
Amarin Investigational Site Marquette Michigan 49855 —
Amarin Investigational Site Troy Michigan 48098 —
Amarin Investigational Site Saint Cloud Minnesota 56303 —
Amarin Investigational Site Biloxi Mississippi 39531 —
Amarin Investigational Site Tupelo Mississippi 38801 —
Amarin Investigational Site Chesterfield Missouri 63141 —
Amarin Investigational Site City of Saint Peters Missouri 63303 —
Amarin Investigational Site Florissant Missouri 63031 —
Amarin Investigational Site Jefferson City Missouri 65109 —
Amarin Investigational Site Kansas City Missouri 64114 —
Amarin Investigational Site St Louis Missouri 63110 —
Amarin Investigational Site Hastings Nebraska 68901 —
Amarin Investigational Site Omaha Nebraska 68114 —
Amarin Investigational Site Omaha Nebraska 68154 —
Amarin Investigational Site Henderson Nevada 89052 —
Amarin Investigational Site Las Vegas Nevada 89101 —
Amarin Investigational Site Ocean City New Jersey 07712 —
Amarin Investigational Site Albuquerque New Mexico 87102 —
Amarin Investigational Site Albany New York 12206 —
Amarin Investigational Site Brooklyn New York 11206 —
Amarin Investigational Site Great Neck New York 11023 —
Amarin Investigational Site Liverpool New York 13088 —
Amarin Investigational Site New York New York 10001 —
Amarin Investigational Site New York New York 10016 —
Amarin Investigational Site North Massapequa New York 11758 —
Amarin Investigational Site Smithtown New York 11787 —
Amarin Investigational Site Vestal New York 13850 —
Amarin Investigational Site West Seneca New York 14224 —
Amarin Investigational Site Charlotte North Carolina 28204 —
Amarin Investigational Site Durham North Carolina 27710 —
Amarin Investigational Site Gastonia North Carolina 28054 —
Amarin Investigational Site Kernersville North Carolina 27284 —
Amarin Investigational Site Raleigh North Carolina 27609 —
Amarin Investigational Site Winston-Salem North Carolina 27157 —
Amarin Investigational Site Fargo North Dakota 58103 —
Amarin Investigational Site Cincinnati Ohio 45219 —
Amarin Investigational Site Dayton Ohio 45419 —
Amarin Investigational Site Lorain Ohio 44053 —
Amarin Investigational Site Sandusky Ohio 44870 —
Amarin Investigational Site Tulsa Oklahoma 74104 —
Amarin Investigational Site Bend Oregon 97702 —
Amarin Investigational Site Portland Oregon 97239 —
Amarin Investigational Site Beaver Pennsylvania 15009 —
Amarin Investigational Site Doylestown Pennsylvania 18901 —
Amarin Investigational Site Jersey Shore Pennsylvania 17740 —
Amarin Investigational Site Newport Pennsylvania 17074 —
Amarin Investigational Site Philadelphia Pennsylvania 19104 —
Amarin Investigational Site Phoenixville Pennsylvania 19460 —
Amarin Investigational Site Sellersville Pennsylvania 18960 —
Amarin Investigational Site Tipton Pennsylvania 16684 —
Amarin Investigational Site Wyomissing Pennsylvania 19610 —
Amarin Investigational Site Yardley Pennsylvania 19067 —
Amarin Investigational Site Lancaster South Carolina 29720 —
Amarin Investigational Site Simpsonville South Carolina 29681 —
Amarin Investigational Site Rapid City South Dakota 57701 —
Amarin Investigational Site Bristol Tennessee 37620 —
Amarin Investigational Site Columbia Tennessee 38401 —
Amarin Investigational Site Germantown Tennessee 38138 —
Amarin Investigational Site Jackson Tennessee 38301 —
Amarin Investigational Site Knoxville Tennessee 37917 —
Amarin Investigational Site Smyrna Tennessee 37167 —
Amarin Investigational Site Austin Texas 78756 —
Amarin Investigational Site Beaumont Texas 77702 —
Amarin Investigational Site Carrollton Texas 75007 —
Amarin Investigational Site Dallas Texas 75231 —
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 Hurst Texas 76054 —
Amarin Investigational Site New Braunfels Texas 78130 —
Amarin Investigational Site Plano Texas 75075 —
Amarin Investigational Site San Antonio Texas 78228 —
Amarin Investigational Site San Antonio Texas 78238 —
Amarin Investigational Site Splendora Texas 77372 —
Amarin Investigational Site Tomball Texas 77375 —
Amarin Investigational Site West Jordan Utah 84088 —
Amarin Investigational Site Falls Church Virginia 22044 —
Amarin Investigational Site Manassas Virginia 20109 —
Amarin Investigational Site Midlothian Virginia 23114 —
Amarin Investigational Site Newport News Virginia 23606 —
Amarin Investigational Site Burien Washington 98166 —
Amarin Investigational Site Tacoma Washington 98405 —
Amarin Investigational Site Huntington West Virginia 25701 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 234 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01492361, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 14, 2022 · Synced Oct 23, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01492361 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →