Last updated: 11/07/2018 18:02:48
Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants with paroxysmal AF with an event of documented symptomatic atrial fibrillation (AF)/Flutter
Timeframe: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)
Secondary outcomes:
Number of participants with persistent AF and in both AF subgroups combined with an event of documented symptomatic AF/flutter
Timeframe: 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)
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: 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 with paroxysmal or persistent AF with an event of documented symptomatic or asymptomatic AF (exclusive of flutter)
Timeframe: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)
Number of participants in both AF subgroups combined with an event of documented symptomatic or asymptomatic AF (exclusive of flutter)
Timeframe: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)
Number of participants with paroxysmal or persistent AF with an event after completion of Day 7 to the occurrence of symptomatic AF/Flutter
Timeframe: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)
Number of participants in the combined AF subgroups with an event after completion of Day 7 to the occurrence of symptomatic AF/Flutter
Timeframe: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)
Number of participants with paroxysmal or persistent AF with an event that occurred after completion of Day 7 to the occurrence of symptomatic AF (exclusive of flutter)
Timeframe: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)
Number of participants in the combined AF subgroups with an event that occurred after completion of Day 7 to the occurrence of symptomatic AF (exclusive of flutter)
Timeframe: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)
Annualized number of AF/Flutter rescue episodes during the treatment period
Timeframe: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
Annualized cumulative frequency of symptomatic AF/Flutter recurrences during the treatment period
Timeframe: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
Annualized cumulative frequency of symptomatic AF recurrences during the treatment period
Timeframe: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
Interventions:
Drug: omega-3-acid ethyl esters
Drug: Placebo
Enrollment:
663
Observational study model:
Not applicable
Primary completion date:
2010-21-01
Time perspective:
Not applicable
Clinical publications:
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;304(21):(doi:10.1001/jama.2010.1735)
Medical condition
Fibrillation, Atrial
Product
GI104000, GSK2295313, omega-3-acid ethyl esters
Collaborators
Not applicable
Study date(s)
November 2006 to January 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Men and women age 18 years or older
- History of symptomatic atrial fibrillation (either paroxysmal or persistent)
- Permanent (chronic) atrial fibrillation
- Antiarrhythmic drug therapy which cannot be stopped
Inclusion and exclusion criteria
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 information disclosure
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 metabolic conditions, or cancer (except non-melanoma skin cancer)
- Poorly controlled diabetes
Trial location(s)
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53215
Status
Study Complete
Location
GSK Investigational Site
Westerly, Rhode Island, United States, 02891
Status
Study Complete
Location
GSK Investigational Site
Cranston, Rhode Island, United States, 02920
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32207
Status
Study Complete
Location
GSK Investigational Site
Kalispell, Montana, United States, 59901
Status
Study Complete
Location
GSK Investigational Site
Mineola, New York, United States, 11501
Status
Study Complete
Location
GSK Investigational Site
Fairview Park, Ohio, United States, 44126
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Kansas, United States, 66102
Status
Study Complete
Location
GSK Investigational Site
Bakersfield, California, United States, 93301
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35215
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10025
Status
Study Complete
Location
GSK Investigational Site
Chesapeake, Virginia, United States, 23510
Status
Study Complete
Location
GSK Investigational Site
Bannockburn, Illinois, United States, 60015
Status
Study Complete
Location
GSK Investigational Site
Billings, Montana, United States, 59101
Status
Study Complete
Location
GSK Investigational Site
Langhorne, Pennsylvania, United States, 19047
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Florida, United States, 32605
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20010
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28203
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97220
Status
Study Complete
Location
GSK Investigational Site
Richlands, Virginia, United States, 24641
Status
Study Complete
Location
GSK Investigational Site
Daytona Beach, Florida, United States, 32114
Status
Study Complete
Location
GSK Investigational Site
La Porte, Indiana, United States, 46350
Status
Study Complete
Location
GSK Investigational Site
Bay Pines, Florida, United States, 33744
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90211
Status
Study Complete
Location
GSK Investigational Site
Missoula, Montana, United States, 59802
Status
Study Complete
Location
GSK Investigational Site
Gurnee, Illinois, United States, 60031
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
Status
Study Complete
Location
GSK Investigational Site
Poway, California, United States, 92064
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73109
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95819
Status
Study Complete
Location
GSK Investigational Site
Morristown, New Jersey, United States, 07962
Status
Study Complete
Location
GSK Investigational Site
Gulfport, Mississippi, United States, 39503
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32803
Status
Study Complete
Location
GSK Investigational Site
Babylon, New York, United States, 11702
Status
Study Complete
Location
GSK Investigational Site
Peoria, Illinois, United States, 61603
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48201
Status
Study Complete
Location
GSK Investigational Site
Bridgeport, Connecticut, United States, 06606
Status
Study Complete
Location
GSK Investigational Site
Guilford, Connecticut, United States, 06437
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29302
Status
Study Complete
Location
GSK Investigational Site
Hillsboro, Oregon, United States, 97123-4117
Status
Study Complete
Location
GSK Investigational Site
South Bend, Indiana, United States, 46601
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Mount Sterling, Kentucky, United States, 40353
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90073
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90033
Status
Study Complete
Location
GSK Investigational Site
Covington, Louisiana, United States, 70433
Status
Study Complete
Location
GSK Investigational Site
Ormond Beach, Florida, United States, 32174
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19102
Status
Study Complete
Location
GSK Investigational Site
Annapolis, Maryland, United States, 20401
Status
Study Complete
Location
GSK Investigational Site
Loma Linda, California, United States, 92354
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85006
Status
Study Complete
Location
GSK Investigational Site
Aurora, Colorado, United States, 80012
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10029
Status
Study Complete
Location
GSK Investigational Site
Wayne, New Jersey, United States, 07470
Status
Study Complete
Location
GSK Investigational Site
West Chester, Pennsylvania, United States, 19380
Status
Study Complete
Location
GSK Investigational Site
Pinellas Park, Florida, United States, 33781
Status
Study Complete
Location
GSK Investigational Site
Carmichael, California, United States, 95608
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40205
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30322
Status
Study Complete
Location
GSK Investigational Site
Cottonwood, Arizona, United States, 86326
Status
Study Complete
Location
GSK Investigational Site
Alamada, California, United States, 94501
Status
Study Complete
Location
GSK Investigational Site
Huntington, West Virginia, United States, 25701
Status
Study Complete
Location
GSK Investigational Site
Pawtucket, Rhode Island, United States, 02860
Status
Study Complete
Location
GSK Investigational Site
Littleton, Colorado, United States, 80120
Status
Study Complete
Location
GSK Investigational Site
Beaver, Pennsylvania, United States, 15009
Status
Study Complete
Location
GSK Investigational Site
Alpena, Michigan, United States, 49707
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10032
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84124
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Arlington, Virginia, United States, 22204
Status
Study Complete
Location
GSK Investigational Site
Statesville, North Carolina, United States, 28625
Status
Study Complete
Location
GSK Investigational Site
Vista, California, United States, 92081
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Springfield, Virginia, United States, 22151
Status
Study Complete
Location
GSK Investigational Site
Mineappolis, Minnesota, United States, 55417
Status
Study Complete
Location
GSK Investigational Site
Bakersfield, California, United States, 93308
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23249
Status
Study Complete
Location
GSK Investigational Site
Greensburg, Pennsylvania, United States, 15601
Status
Study Complete
Location
GSK Investigational Site
Brookline, Massachusetts, United States, 02446
Status
Study Complete
Location
GSK Investigational Site
Merced, California, United States, 95348
Status
Study Complete
Location
GSK Investigational Site
Melbourne, Florida, United States, 32901
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20017
Status
Study Complete
Location
GSK Investigational Site
Wynnewood, Pennsylvania, United States, 19096
Status
Study Complete
Location
GSK Investigational Site
Scarborough, Maine, United States, 04074
Status
Study Complete
Location
GSK Investigational Site
Fair Oaks, California, United States, 95628
Status
Study Complete
Location
GSK Investigational Site
Hershey, Pennsylvania, United States, 17033
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Palm Springs, California, United States, 92262
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90210
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Location
GSK Investigational Site
Lansing, Michigan, United States, 48910
Status
Study Complete
Location
GSK Investigational Site
Beloit, Wisconsin, United States, 53511
Status
Study Complete
Location
GSK Investigational Site
Jupiter, Florida, United States, 33458
Status
Study Complete
Location
GSK Investigational Site
Cadillac, Michigan, United States, 49601
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Burien, Washington, United States, 98166
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92161
Status
Study Complete
Location
GSK Investigational Site
Elkhart, Indiana, United States, 46514
Status
Study Complete
Location
GSK Investigational Site
Fort Meyers, Florida, United States, 33919
Status
Study Complete
Location
GSK Investigational Site
Corvalis, Oregon, United States, 97330
Status
Study Complete
Location
GSK Investigational Site
Pensacola, Florida, United States, 32514
Status
Study Complete
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28601
Status
Study Complete
Location
GSK Investigational Site
Sioux Falls, South Dakota, United States, 57105
Status
Study Complete
Location
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
Status
Study Complete
Location
GSK Investigational Site
Wausau, Wisconsin, United States, 54401
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
Status
Study Complete
Location
GSK Investigational Site
Jackson, Tennessee, United States, 38301
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30328
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14215
Status
Study Complete
Location
GSK Investigational Site
Farmington, Connecticut, United States, 06030
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85014
Status
Study Complete
Location
GSK Investigational Site
Redondo Beach, California, United States, 90277
Status
Study Complete
Location
GSK Investigational Site
Delray Beach, Florida, United States, 33484
Status
Study Complete
Location
GSK Investigational Site
Kissimmee, Florida, United States, 34741
Status
Study Complete
Location
GSK Investigational Site
Huntsville, Alabama, United States, 35801
Status
Study Complete
Location
GSK Investigational Site
Ayer, Massachusetts, United States, 01432
Status
Study Complete
Location
GSK Investigational Site
West Islip, New York, United States, 11794
Status
Study Complete
Location
GSK Investigational Site
Normal, Illinois, United States, 61761
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14209
Status
Study Complete
Location
GSK Investigational Site
Summit, New Jersey, United States, 07901
Status
Study Complete
Location
GSK Investigational Site
Lacombe, Louisiana, United States, 70445
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97223
Status
Study Complete
Location
GSK Investigational Site
St Paul, Minnesota, United States, 55102
Status
Study Complete
Location
GSK Investigational Site
Biddeford, Maine, United States, 04005
Status
Study Complete
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Wyomissing, Pennsylvania, United States, 19610
Status
Study Complete
Location
GSK Investigational Site
Fort Smith, Arkansas, United States, 72901
Status
Study Complete
Location
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Study Complete
Location
GSK Investigational Site
Corpus Christi, Texas, United States, 78404
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38120
Status
Study Complete
Location
GSK Investigational Site
Grand Forks, North Dakota, United States, 58201
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85032
Status
Study Complete
Location
GSK Investigational Site
Anchorage, Alaska, United States, 99508
Status
Study Complete
Location
GSK Investigational Site
Worcester, Massachusetts, United States, 01655
Status
Study Complete
Location
GSK Investigational Site
Decatur, Georgia, United States, 30030
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28080
Status
Study Complete
Location
GSK Investigational Site
Rochester Hills, Minnesota, United States, 48307
Status
Study Complete
Location
GSK Investigational Site
Ridley Park, Pennsylvania, United States, 19078
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-21-01
Actual study completion date
2010-21-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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