Clinical trial NCT00402363: Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibrillation, Atrial
Keywords: Lovaza
Omega-3 fatty acids
Omacor
Paroxysmal atrial fibrillation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 663
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Anchorage
country: United States
facility: GSK Investigational Site
state: Alaska
city: Cottonwood
country: United States
facility: GSK Investigational Site
state: Arizona
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Fort Smith
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Hot Springs
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Alamada
country: United States
facility: GSK Investigational Site
state: California
city: Bakersfield
country: United States
facility: GSK Investigational Site
state: California
city: Bakersfield
country: United States
facility: GSK Investigational Site
state: California
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: Carmichael
country: United States
facility: GSK Investigational Site
state: California
city: Fair Oaks
country: United States
facility: GSK Investigational Site
state: California
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Loma Linda
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Merced
country: United States
facility: GSK Investigational Site
state: California
city: Palm Springs
country: United States
facility: GSK Investigational Site
state: California
city: Poway
country: United States
facility: GSK Investigational Site
state: California
city: Redondo Beach
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
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state: California
city: San Diego
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state: California
city: Vista
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state: California
city: Walnut Creek
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state: California
city: Aurora
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facility: GSK Investigational Site
state: Colorado
city: Colorado Springs
country: United States
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state: Colorado
city: Littleton
country: United States
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state: Colorado
city: Bridgeport
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Farmington
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Guilford
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Aventura
country: United States
facility: GSK Investigational Site
state: Florida
city: Bay Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Daytona Beach
country: United States
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state: Florida
city: Delray Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Meyers
country: United States
facility: GSK Investigational Site
state: Florida
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Hudson
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Jupiter
country: United States
facility: GSK Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: GSK Investigational Site
state: Florida
city: Largo
country: United States
facility: GSK Investigational Site
state: Florida
city: Melbourne
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Ocala
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Ormond Beach
country: United States
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state: Florida
city: Pensacola
country: United States
facility: GSK Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Tucker
country: United States
facility: GSK Investigational Site
state: Georgia
city: Bannockburn
country: United States
facility: GSK Investigational Site
state: Illinois
city: Gurnee
country: United States
facility: GSK Investigational Site
state: Illinois
city: Normal
country: United States
facility: GSK Investigational Site
state: Illinois
city: Peoria
country: United States
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state: Illinois
city: Elkhart
country: United States
facility: GSK Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: La Porte
country: United States
facility: GSK Investigational Site
state: Indiana
city: South Bend
country: United States
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state: Indiana
city: Kansas City
country: United States
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state: Kansas
city: Louisville
country: United States
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state: Kentucky
city: Mount Sterling
country: United States
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state: Kentucky
city: Covington
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Lacombe
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Auburn
country: United States
facility: GSK Investigational Site
state: Maine
city: Biddeford
country: United States
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state: Maine
city: Portland
country: United States
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state: Maine
city: Scarborough
country: United States
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state: Maine
city: Annapolis
country: United States
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state: Maryland
city: Ayer
country: United States
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state: Massachusetts
city: Brookline
country: United States
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state: Massachusetts
city: Worcester
country: United States
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state: Massachusetts
city: Alpena
country: United States
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state: Michigan
city: Cadillac
country: United States
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state: Michigan
city: Detroit
country: United States
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city: Kalamazoo
country: United States
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state: Michigan
city: Lansing
country: United States
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state: Michigan
city: Mineappolis
country: United States
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state: Minnesota
city: Rochester Hills
country: United States
facility: GSK Investigational Site
state: Minnesota
city: St Paul
country: United States
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state: Minnesota
city: Gulfport
country: United States
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state: Mississippi
city: Billings
country: United States
facility: GSK Investigational Site
state: Montana
city: Kalispell
country: United States
facility: GSK Investigational Site
state: Montana
city: Missoula
country: United States
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state: Montana
city: Morristown
country: United States
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state: New Jersey
city: Summit
country: United States
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state: New Jersey
city: Wayne
country: United States
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state: New Jersey
city: Babylon
country: United States
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state: New York
city: Buffalo
country: United States
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state: New York
city: Buffalo
country: United States
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state: New York
city: Mineola
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Troy
country: United States
facility: GSK Investigational Site
state: New York
city: West Islip
country: United States
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state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Grand Forks
country: United States
facility: GSK Investigational Site
state: North Dakota
city: Akron
country: United States
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state: Ohio
city: Bryan
country: United States
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state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Cleveland
country: United States
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state: Ohio
city: Fairview Park
country: United States
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state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Oklahoma City
country: United States
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state: Oklahoma
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Corvalis
country: United States
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city: Hillsboro
country: United States
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state: Oregon
city: Portland
country: United States
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country: United States
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country: United States
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state: Pennsylvania
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country: United States
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country: United States
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state: Pennsylvania
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country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Ridley Park
country: United States
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state: Pennsylvania
city: West Chester
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Wynnewood
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Wyomissing
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Cranston
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Pawtucket
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Westerly
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Sioux Falls
country: United States
facility: GSK Investigational Site
state: South Dakota
city: Jackson
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Beaumont
country: United States
facility: GSK Investigational Site
state: Texas
city: Corpus Christi
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Humble
country: United States
facility: GSK Investigational Site
state: Texas
city: Lubbock
country: United States
facility: GSK Investigational Site
state: Texas
city: McKinney
country: United States
facility: GSK Investigational Site
state: Texas
city: Odessa
country: United States
facility: GSK Investigational Site
state: Texas
city: Odessa
country: United States
facility: GSK Investigational Site
state: Texas
city: Orange
country: United States
facility: GSK Investigational Site
state: Texas
city: Tyler
country: United States
facility: GSK Investigational Site
state: Texas
city: Waco
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Arlington
country: United States
facility: GSK Investigational Site
state: Virginia
city: Chesapeake
country: United States
facility: GSK Investigational Site
state: Virginia
city: Galax
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richlands
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Springfield
country: United States
facility: GSK Investigational Site
state: Virginia
city: Burien
country: United States
facility: GSK Investigational Site
state: Washington
city: Huntington
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Beloit
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Marshfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Wausau
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.