Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
NCT ID: NCT00402363
Last Updated: 2017-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
663 participants
INTERVENTIONAL
2006-11-30
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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omega-3-acid ethyl esters
omega-3-acid ethyl esters
Placebo
Placebo
Interventions
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omega-3-acid ethyl esters
Placebo
Eligibility Criteria
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Inclusion Criteria
* History of symptomatic atrial fibrillation (either paroxysmal or persistent)
* Provide written informed consent and authorization for protected health information disclosure
Exclusion Criteria
* 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 metabolic conditions, or cancer (except non-melanoma skin cancer)
* Poorly controlled diabetes
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Anchorage, Alaska, United States
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Cottonwood, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Fort Smith, Arkansas, United States
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Hot Springs, Arkansas, United States
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Alamada, California, United States
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Bakersfield, California, United States
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Bakersfield, California, United States
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Beverly Hills, California, United States
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Carmichael, California, United States
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Fair Oaks, California, United States
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Fountain Valley, California, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Merced, California, United States
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Palm Springs, California, United States
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Poway, California, United States
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Redondo Beach, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Vista, California, United States
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Walnut Creek, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Littleton, Colorado, United States
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Bridgeport, Connecticut, United States
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Farmington, Connecticut, United States
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Guilford, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Aventura, Florida, United States
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Bay Pines, Florida, United States
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Daytona Beach, Florida, United States
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Delray Beach, Florida, United States
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Fort Meyers, Florida, United States
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Gainesville, Florida, United States
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Hudson, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Largo, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Pensacola, Florida, United States
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Pinellas Park, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Tucker, Georgia, United States
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Bannockburn, Illinois, United States
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Gurnee, Illinois, United States
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Normal, Illinois, United States
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Peoria, Illinois, United States
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Elkhart, Indiana, United States
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Indianapolis, Indiana, United States
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La Porte, Indiana, United States
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South Bend, Indiana, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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Mount Sterling, Kentucky, United States
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Covington, Louisiana, United States
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Lacombe, Louisiana, United States
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Auburn, Maine, United States
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Biddeford, Maine, United States
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Portland, Maine, United States
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Scarborough, Maine, United States
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Annapolis, Maryland, United States
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Ayer, Massachusetts, United States
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Brookline, Massachusetts, United States
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Worcester, Massachusetts, United States
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Alpena, Michigan, United States
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Cadillac, Michigan, United States
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Detroit, Michigan, United States
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Kalamazoo, Michigan, United States
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Lansing, Michigan, United States
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Mineappolis, Minnesota, United States
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Rochester Hills, Minnesota, United States
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Saint Paul, Minnesota, United States
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Gulfport, Mississippi, United States
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Billings, Montana, United States
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Kalispell, Montana, United States
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Missoula, Montana, United States
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Morristown, New Jersey, United States
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Summit, New Jersey, United States
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Wayne, New Jersey, United States
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Babylon, New York, United States
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Buffalo, New York, United States
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Buffalo, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Troy, New York, United States
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West Islip, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Hickory, North Carolina, United States
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Statesville, North Carolina, United States
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Grand Forks, North Dakota, United States
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Akron, Ohio, United States
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Bryan, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Fairview Park, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Corvalis, Oregon, United States
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Hillsboro, Oregon, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Beaver, Pennsylvania, United States
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Greensburg, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Ridley Park, Pennsylvania, United States
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West Chester, Pennsylvania, United States
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Wynnewood, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Cranston, Rhode Island, United States
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Pawtucket, Rhode Island, United States
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Westerly, Rhode Island, United States
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Greer, South Carolina, United States
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Spartanburg, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Jackson, Tennessee, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Lubbock, Texas, United States
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McKinney, Texas, United States
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Odessa, Texas, United States
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Odessa, Texas, United States
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Orange, Texas, United States
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Tyler, Texas, United States
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Waco, Texas, United States
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Salt Lake City, Utah, United States
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Arlington, Virginia, United States
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Chesapeake, Virginia, United States
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Galax, Virginia, United States
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Richlands, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Springfield, Virginia, United States
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Burien, Washington, United States
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Huntington, West Virginia, United States
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Beloit, Wisconsin, United States
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Madison, Wisconsin, United States
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Marshfield, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Wausau, Wisconsin, United States
Countries
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References
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Kowey PR, Reiffel JA, Ellenbogen KA, Naccarelli GV, Pratt CM. Efficacy and safety of prescription omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: a randomized controlled trial. JAMA. 2010 Dec 1;304(21):2363-72. doi: 10.1001/jama.2010.1735. Epub 2010 Nov 15.
Pratt CM, Reiffel JA, Ellenbogen KA, Naccarelli GV, Kowey PR. Efficacy and safety of prescription omega-3-acid ethyl esters for the prevention of recurrent symptomatic atrial fibrillation: a prospective study. Am Heart J. 2009 Aug;158(2):163-169.e1-3. doi: 10.1016/j.ahj.2009.05.024.
Study Documents
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Document Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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OM8 Afib
Identifier Type: -
Identifier Source: org_study_id
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