Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation

Last updated: December 1, 2016
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Chest Pain

Cardiac Disease

Dysrhythmia

Treatment

Placebo

omega-3-acid ethyl esters

Clinical Study ID

NCT00402363
OM8 Afib
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women age 18 years or older

  • History of symptomatic atrial fibrillation (either paroxysmal or persistent)

  • Provide written informed consent and authorization for protected health informationdisclosure

Exclusion

Exclusion Criteria:

  • Permanent (chronic) atrial fibrillation

  • Antiarrhythmic drug therapy which cannot be stopped

  • Use of amiodarone with prior 6 months

  • History of unsuccessful cardioversion

  • History of certain cardiovascular conditions or cardiac surgery within prior 6 months

  • History of stroke within prior 6 months

  • Implanted cardio-defibrillator

  • Certain circulatory, thyroid, pulmonary, liver, kidney, musculoskeletal or metabolicconditions, or cancer (except non-melanoma skin cancer)

  • Poorly controlled diabetes

Study Design

Total Participants: 663
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 01, 2006
Estimated Completion Date:
January 31, 2010

Connect with a study center

  • GSK Investigational Site

    Birmingham, Alabama 35215
    United States

    Site Not Available

  • GSK Investigational Site

    Huntsville, Alabama 35801
    United States

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  • GSK Investigational Site

    Anchorage, Alaska 99508
    United States

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  • GSK Investigational Site

    Cottonwood, Arizona 86326
    United States

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  • GSK Investigational Site

    Mesa, Arizona 85206
    United States

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  • GSK Investigational Site

    Phoenix, Arizona 85014
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  • GSK Investigational Site

    Tucson, Arizona 85724
    United States

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  • GSK Investigational Site

    Fort Smith, Arkansas 72901
    United States

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  • GSK Investigational Site

    Hot Springs, Arkansas 71913
    United States

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  • GSK Investigational Site

    Alamada, California 94501
    United States

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  • GSK Investigational Site

    Bakersfield, California 93301
    United States

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  • GSK Investigational Site

    Beverly Hills, California 90210
    United States

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  • GSK Investigational Site

    Carmichael, California 95608
    United States

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    Fair Oaks, California 95628
    United States

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    Fountain Valley, California 92708
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    Loma Linda, California 92354
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    Los Angeles, California 90073
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    Merced, California 95348
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    Palm Springs, California 92262
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    Poway, California 92064
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    Redondo Beach, California 90277
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    Sacramento, California 95819
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    San Diego, California 92161
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    Vista, California 92081
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    Walnut Creek, California 94598
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    Aurora, Colorado 80012
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    Colorado Springs, Colorado 80907
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    Littleton, Colorado 80120
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    Bridgeport, Connecticut 06606
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    Farmington, Connecticut 06030
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    Guilford, Connecticut 06437
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    Washington, District of Columbia 20017
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    Aventura, Florida 33180
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    Bay Pines, Florida 33744
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    Daytona Beach, Florida 32114
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    Delray Beach, Florida 33484
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    Fort Meyers, Florida 33919
    United States

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    Gainesville, Florida 32605
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    Hudson, Florida 34667
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    Jacksonville, Florida 32207
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    Jupiter, Florida 33458
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    Kissimmee, Florida 34741
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    Largo, Florida 33773
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    Melbourne, Florida 32901
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    Miami, Florida 33136
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    Ocala, Florida 34471
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    Orlando, Florida 32803
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    Ormond Beach, Florida 32174
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    Pensacola, Florida 32514
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    Pinellas Park, Florida 33781
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  • GSK Investigational Site

    Tampa, Florida 33607
    United States

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  • GSK Investigational Site

    Atlanta, Georgia 30322
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    Decatur, Georgia 30030
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    Tucker, Georgia 30084
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    Bannockburn, Illinois 60015
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  • GSK Investigational Site

    Gurnee, Illinois 60031
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  • GSK Investigational Site

    Normal, Illinois 61761
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    Peoria, Illinois 61603
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    Elkhart, Indiana 46514
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    Indianapolis, Indiana 46260
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    La Porte, Indiana 46350
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    South Bend, Indiana 46601
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  • GSK Investigational Site

    Kansas City, Kansas 66102
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  • GSK Investigational Site

    Louisville, Kentucky 40205
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  • GSK Investigational Site

    Mount Sterling, Kentucky 40353
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    Covington, Louisiana 70433
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    Lacombe, Louisiana 70445
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  • GSK Investigational Site

    Auburn, Maine 04210
    United States

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    Biddeford, Maine 04005
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    Portland, Maine 04106
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    Scarborough, Maine 04074
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    Annapolis, Maryland 20401
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    Ayer, Massachusetts 01432
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    Brookline, Massachusetts 02446
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    Worcester, Massachusetts 01655
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    Alpena, Michigan 49707
    United States

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    Cadillac, Michigan 49601
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    Detroit, Michigan 48201
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    Kalamazoo, Michigan 49048
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    Lansing, Michigan 48910
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    Mineappolis, Minnesota 55417
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    Rochester Hills, Minnesota 48307
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    St Paul, Minnesota 55102
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    Gulfport, Mississippi 39503
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    Billings, Montana 59101
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    Kalispell, Montana 59901
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    Missoula, Montana 59802
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  • GSK Investigational Site

    Morristown, New Jersey 07962
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  • GSK Investigational Site

    Summit, New Jersey 07901
    United States

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  • GSK Investigational Site

    Wayne, New Jersey 07470
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  • GSK Investigational Site

    Babylon, New York 11702
    United States

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  • GSK Investigational Site

    Buffalo, New York 14209
    United States

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  • GSK Investigational Site

    Mineola, New York 11501
    United States

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  • GSK Investigational Site

    New York, New York 10032
    United States

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  • GSK Investigational Site

    Troy, New York 12180
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    West Islip, New York 11794
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    Charlotte, North Carolina 28203
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  • GSK Investigational Site

    Hickory, North Carolina 28601
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  • GSK Investigational Site

    Statesville, North Carolina 28625
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  • GSK Investigational Site

    Grand Forks, North Dakota 58201
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  • GSK Investigational Site

    Akron, Ohio 44304
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  • GSK Investigational Site

    Bryan, Ohio 43506
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  • GSK Investigational Site

    Cincinnati, Ohio 45219
    United States

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  • GSK Investigational Site

    Cleveland, Ohio 44106
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  • GSK Investigational Site

    Fairview Park, Ohio 44126
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  • GSK Investigational Site

    Oklahoma City, Oklahoma 73109
    United States

    Site Not Available

  • GSK Investigational Site

    Corvalis, Oregon 97330
    United States

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  • GSK Investigational Site

    Hillsboro, Oregon 97123-4117
    United States

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  • GSK Investigational Site

    Beaver, Pennsylvania 15009
    United States

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  • GSK Investigational Site

    Greensburg, Pennsylvania 15601
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  • GSK Investigational Site

    Hershey, Pennsylvania 17033
    United States

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  • GSK Investigational Site

    Langhorne, Pennsylvania 19047
    United States

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  • GSK Investigational Site

    Philadelphia, Pennsylvania 19102
    United States

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  • GSK Investigational Site

    Ridley Park, Pennsylvania 19078
    United States

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  • GSK Investigational Site

    West Chester, Pennsylvania 19380
    United States

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  • GSK Investigational Site

    Wynnewood, Pennsylvania 19096
    United States

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  • GSK Investigational Site

    Wyomissing, Pennsylvania 19610
    United States

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  • GSK Investigational Site

    Cranston, Rhode Island 02920
    United States

    Site Not Available

  • GSK Investigational Site

    Pawtucket, Rhode Island 02860
    United States

    Site Not Available

  • GSK Investigational Site

    Westerly, Rhode Island 02891
    United States

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  • GSK Investigational Site

    Greer, South Carolina 29651
    United States

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  • GSK Investigational Site

    Spartanburg, South Carolina 29302
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  • GSK Investigational Site

    Sioux Falls, South Dakota 57105
    United States

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  • GSK Investigational Site

    Jackson, Tennessee 38301
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  • GSK Investigational Site

    Memphis, Tennessee 38120
    United States

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  • GSK Investigational Site

    Austin, Texas 78705
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  • GSK Investigational Site

    Beaumont, Texas 77702
    United States

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  • GSK Investigational Site

    Corpus Christi, Texas 78404
    United States

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  • GSK Investigational Site

    Dallas, Texas 75231
    United States

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  • GSK Investigational Site

    Houston, Texas 77090
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  • GSK Investigational Site

    Humble, Texas 77338
    United States

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  • GSK Investigational Site

    Lubbock, Texas 79410
    United States

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  • GSK Investigational Site

    McKinney, Texas 75069
    United States

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  • GSK Investigational Site

    Odessa, Texas 79764
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  • GSK Investigational Site

    Orange, Texas 77630
    United States

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  • GSK Investigational Site

    Tyler, Texas 75701
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  • GSK Investigational Site

    Waco, Texas 76712
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  • GSK Investigational Site

    Salt Lake City, Utah 84124
    United States

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  • GSK Investigational Site

    Arlington, Virginia 22204
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  • GSK Investigational Site

    Chesapeake, Virginia 23510
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  • GSK Investigational Site

    Galax, Virginia 24333
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  • GSK Investigational Site

    Richlands, Virginia 24641
    United States

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  • GSK Investigational Site

    Richmond, Virginia 23294
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  • GSK Investigational Site

    Springfield, Virginia 22151
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  • GSK Investigational Site

    Burien, Washington 98166
    United States

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  • GSK Investigational Site

    Huntington, West Virginia 25701
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  • GSK Investigational Site

    Beloit, Wisconsin 53511
    United States

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  • GSK Investigational Site

    Madison, Wisconsin 53792
    United States

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  • GSK Investigational Site

    Marshfield, Wisconsin 54449
    United States

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  • GSK Investigational Site

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

  • GSK Investigational Site

    Wausau, Wisconsin 54401
    United States

    Site Not Available

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