Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of Lovaza for the Prevention of Recurrent, Symptomatic Atrial Fibrillation
1 other identifier
interventional
663
1 country
178
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2006
Typical duration for phase_3
178 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 20, 2006
CompletedFirst Posted
Study publicly available on registry
November 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
October 15, 2010
CompletedJanuary 30, 2017
December 1, 2016
3.2 years
November 20, 2006
September 23, 2010
December 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter
A documented episode of symptomatic AF /Flutter was defined as AF/Flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter.
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)
Secondary Outcomes (14)
Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)
Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)
Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)
Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter
From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)
Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter
From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)
- +9 more secondary outcomes
Study Arms (2)
omega-3-acid ethyl esters
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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 information disclosure
You may not qualify if:
- 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 metabolic conditions, or cancer (except non-melanoma skin cancer)
- Poorly controlled diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (178)
GSK Investigational Site
Birmingham, Alabama, 35215, United States
GSK Investigational Site
Huntsville, Alabama, 35801, United States
GSK Investigational Site
Anchorage, Alaska, 99508, United States
GSK Investigational Site
Cottonwood, Arizona, 86326, United States
GSK Investigational Site
Mesa, Arizona, 85206, United States
GSK Investigational Site
Phoenix, Arizona, 85006, United States
GSK Investigational Site
Phoenix, Arizona, 85014, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Tucson, Arizona, 85724, United States
GSK Investigational Site
Fort Smith, Arkansas, 72901, United States
GSK Investigational Site
Hot Springs, Arkansas, 71913, United States
GSK Investigational Site
Alamada, California, 94501, United States
GSK Investigational Site
Bakersfield, California, 93301, United States
GSK Investigational Site
Bakersfield, California, 93308, United States
GSK Investigational Site
Beverly Hills, California, 90210, United States
GSK Investigational Site
Carmichael, California, 95608, United States
GSK Investigational Site
Fair Oaks, California, 95628, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
Loma Linda, California, 92354, United States
GSK Investigational Site
Los Angeles, California, 90033, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Los Angeles, California, 90073, United States
GSK Investigational Site
Los Angeles, California, 90211, United States
GSK Investigational Site
Merced, California, 95348, United States
GSK Investigational Site
Palm Springs, California, 92262, United States
GSK Investigational Site
Poway, California, 92064, United States
GSK Investigational Site
Redondo Beach, California, 90277, United States
GSK Investigational Site
Sacramento, California, 95819, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
San Diego, California, 92161, United States
GSK Investigational Site
Vista, California, 92081, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
Aurora, Colorado, 80012, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
Littleton, Colorado, 80120, United States
GSK Investigational Site
Bridgeport, Connecticut, 06606, United States
GSK Investigational Site
Farmington, Connecticut, 06030, United States
GSK Investigational Site
Guilford, Connecticut, 06437, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20010, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20017, United States
GSK Investigational Site
Aventura, Florida, 33180, United States
GSK Investigational Site
Bay Pines, Florida, 33744, United States
GSK Investigational Site
Daytona Beach, Florida, 32114, United States
GSK Investigational Site
Delray Beach, Florida, 33484, United States
GSK Investigational Site
Fort Meyers, Florida, 33919, United States
GSK Investigational Site
Gainesville, Florida, 32605, United States
GSK Investigational Site
Hudson, Florida, 34667, United States
GSK Investigational Site
Jacksonville, Florida, 32207, United States
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
Jupiter, Florida, 33458, United States
GSK Investigational Site
Kissimmee, Florida, 34741, United States
GSK Investigational Site
Largo, Florida, 33773, United States
GSK Investigational Site
Melbourne, Florida, 32901, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
Miami, Florida, 33137, United States
GSK Investigational Site
Miami, Florida, 33176, United States
GSK Investigational Site
Ocala, Florida, 34471, United States
GSK Investigational Site
Orlando, Florida, 32803, United States
GSK Investigational Site
Ormond Beach, Florida, 32174, United States
GSK Investigational Site
Pensacola, Florida, 32514, United States
GSK Investigational Site
Pinellas Park, Florida, 33781, United States
GSK Investigational Site
Tampa, Florida, 33607, United States
GSK Investigational Site
Atlanta, Georgia, 30322, United States
GSK Investigational Site
Atlanta, Georgia, 30328, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Decatur, Georgia, 30030, United States
GSK Investigational Site
Tucker, Georgia, 30084, United States
GSK Investigational Site
Bannockburn, Illinois, 60015, United States
GSK Investigational Site
Gurnee, Illinois, 60031, United States
GSK Investigational Site
Normal, Illinois, 61761, United States
GSK Investigational Site
Peoria, Illinois, 61603, United States
GSK Investigational Site
Elkhart, Indiana, 46514, United States
GSK Investigational Site
Indianapolis, Indiana, 46260, United States
GSK Investigational Site
La Porte, Indiana, 46350, United States
GSK Investigational Site
South Bend, Indiana, 46601, United States
GSK Investigational Site
Kansas City, Kansas, 66102, United States
GSK Investigational Site
Louisville, Kentucky, 40205, United States
GSK Investigational Site
Mount Sterling, Kentucky, 40353, United States
GSK Investigational Site
Covington, Louisiana, 70433, United States
GSK Investigational Site
Lacombe, Louisiana, 70445, United States
GSK Investigational Site
Auburn, Maine, 04210, United States
GSK Investigational Site
Biddeford, Maine, 04005, United States
GSK Investigational Site
Portland, Maine, 04106, United States
GSK Investigational Site
Scarborough, Maine, 04074, United States
GSK Investigational Site
Annapolis, Maryland, 20401, United States
GSK Investigational Site
Ayer, Massachusetts, 01432, United States
GSK Investigational Site
Brookline, Massachusetts, 02446, United States
GSK Investigational Site
Worcester, Massachusetts, 01655, United States
GSK Investigational Site
Alpena, Michigan, 49707, United States
GSK Investigational Site
Cadillac, Michigan, 49601, United States
GSK Investigational Site
Detroit, Michigan, 48201, United States
GSK Investigational Site
Kalamazoo, Michigan, 49048, United States
GSK Investigational Site
Lansing, Michigan, 48910, United States
GSK Investigational Site
Mineappolis, Minnesota, 55417, United States
GSK Investigational Site
Rochester Hills, Minnesota, 48307, United States
GSK Investigational Site
Saint Paul, Minnesota, 55102, United States
GSK Investigational Site
Gulfport, Mississippi, 39503, United States
GSK Investigational Site
Billings, Montana, 59101, United States
GSK Investigational Site
Kalispell, Montana, 59901, United States
GSK Investigational Site
Missoula, Montana, 59802, United States
GSK Investigational Site
Morristown, New Jersey, 07962, United States
GSK Investigational Site
Summit, New Jersey, 07901, United States
GSK Investigational Site
Wayne, New Jersey, 07470, United States
GSK Investigational Site
Babylon, New York, 11702, United States
GSK Investigational Site
Buffalo, New York, 14209, United States
GSK Investigational Site
Buffalo, New York, 14215, United States
GSK Investigational Site
Mineola, New York, 11501, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
New York, New York, 10025, United States
GSK Investigational Site
New York, New York, 10029, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
Troy, New York, 12180, United States
GSK Investigational Site
West Islip, New York, 11794, United States
GSK Investigational Site
Charlotte, North Carolina, 28080, United States
GSK Investigational Site
Charlotte, North Carolina, 28203, United States
GSK Investigational Site
Hickory, North Carolina, 28601, United States
GSK Investigational Site
Statesville, North Carolina, 28625, United States
GSK Investigational Site
Grand Forks, North Dakota, 58201, United States
GSK Investigational Site
Akron, Ohio, 44304, United States
GSK Investigational Site
Bryan, Ohio, 43506, United States
GSK Investigational Site
Cincinnati, Ohio, 45219, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Fairview Park, Ohio, 44126, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73109, United States
GSK Investigational Site
Corvalis, Oregon, 97330, United States
GSK Investigational Site
Hillsboro, Oregon, 97123-4117, United States
GSK Investigational Site
Portland, Oregon, 97220, United States
GSK Investigational Site
Portland, Oregon, 97223, United States
GSK Investigational Site
Beaver, Pennsylvania, 15009, United States
GSK Investigational Site
Greensburg, Pennsylvania, 15601, United States
GSK Investigational Site
Hershey, Pennsylvania, 17033, United States
GSK Investigational Site
Langhorne, Pennsylvania, 19047, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19102, United States
GSK Investigational Site
Ridley Park, Pennsylvania, 19078, United States
GSK Investigational Site
West Chester, Pennsylvania, 19380, United States
GSK Investigational Site
Wynnewood, Pennsylvania, 19096, United States
GSK Investigational Site
Wyomissing, Pennsylvania, 19610, United States
GSK Investigational Site
Cranston, Rhode Island, 02920, United States
GSK Investigational Site
Pawtucket, Rhode Island, 02860, United States
GSK Investigational Site
Westerly, Rhode Island, 02891, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Spartanburg, South Carolina, 29302, United States
GSK Investigational Site
Sioux Falls, South Dakota, 57105, United States
GSK Investigational Site
Jackson, Tennessee, 38301, United States
GSK Investigational Site
Memphis, Tennessee, 38120, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Beaumont, Texas, 77702, United States
GSK Investigational Site
Corpus Christi, Texas, 78404, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Houston, Texas, 77074, United States
GSK Investigational Site
Houston, Texas, 77090, United States
GSK Investigational Site
Humble, Texas, 77338, United States
GSK Investigational Site
Lubbock, Texas, 79410, United States
GSK Investigational Site
McKinney, Texas, 75069, United States
GSK Investigational Site
Odessa, Texas, 79761, United States
GSK Investigational Site
Odessa, Texas, 79764, United States
GSK Investigational Site
Orange, Texas, 77630, United States
GSK Investigational Site
Tyler, Texas, 75701, United States
GSK Investigational Site
Waco, Texas, 76712, United States
GSK Investigational Site
Salt Lake City, Utah, 84124, United States
GSK Investigational Site
Arlington, Virginia, 22204, United States
GSK Investigational Site
Chesapeake, Virginia, 23510, United States
GSK Investigational Site
Galax, Virginia, 24333, United States
GSK Investigational Site
Richlands, Virginia, 24641, United States
GSK Investigational Site
Richmond, Virginia, 23249, United States
GSK Investigational Site
Richmond, Virginia, 23294, United States
GSK Investigational Site
Springfield, Virginia, 22151, United States
GSK Investigational Site
Burien, Washington, 98166, United States
GSK Investigational Site
Huntington, West Virginia, 25701, United States
GSK Investigational Site
Beloit, Wisconsin, 53511, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
GSK Investigational Site
Marshfield, Wisconsin, 54449, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53215, United States
GSK Investigational Site
Wausau, Wisconsin, 54401, United States
Related Publications (2)
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.
PMID: 21078810RESULTPratt 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.
PMID: 19619690DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2006
First Posted
November 22, 2006
Study Start
November 1, 2006
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
January 30, 2017
Results First Posted
October 15, 2010
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.