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

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GSK study ID
OM8 Afib
See study documents
Clinicaltrials.gov ID
NCT00402363
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2010-21-01
    Observational study model:
    Not applicable
    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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53215
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Westerly, Rhode Island, United States, 02891
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cranston, Rhode Island, United States, 02920
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32207
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kalispell, Montana, United States, 59901
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44106
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 178 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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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