Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00402363
First received: November 20, 2006
Last updated: February 7, 2013
Last verified: February 2012
Results First Received: September 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Fibrillation, Atrial
Atrial Fibrillation
Interventions: Drug: omega-3-acid ethyl esters
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Paroxysmal AF, P-OM3 Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
Paroxysmal AF, Placebo Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
Persistent AF, P-OM3 Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
Persistent AF, Placebo Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.

Participant Flow:   Overall Study
    Paroxysmal AF, P-OM3     Paroxysmal AF, Placebo     Persistent AF, P-OM3     Persistent AF, Placebo  
STARTED     266     276     66     55  
COMPLETED     233     246     60     45  
NOT COMPLETED     33     30     6     10  
Adverse Event                 9                 14                 2                 2  
Withdrew Consent                 10                 5                 2                 1  
Protocol Violation                 3                 5                 0                 3  
Lost to Follow-up                 5                 4                 0                 2  
Captured as "Other"                 6                 2                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Paroxysmal AF, P-OM3 Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
Paroxysmal AF, Placebo Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
Persistent AF, P-OM3 Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
Persistent AF, Placebo Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
Total Total of all reporting groups

Baseline Measures
    Paroxysmal AF, P-OM3     Paroxysmal AF, Placebo     Persistent AF, P-OM3     Persistent AF, Placebo     Total  
Number of Participants  
[units: participants]
  266     276     66     55     663  
Age  
[units: Years]
Mean ± Standard Deviation
  60.0  ± 13.56     61.9  ± 11.57     58.7  ± 12.65     57.6  ± 14.85     60.5  ± 12.84  
Gender  
[units: Participants]
         
Female     119     138     14     19     290  
Male     147     138     52     36     373  
Race/Ethnicity, Customized  
[units: participants]
         
White/Caucasian     246     253     63     45     607  
African American     10     10     2     6     28  
Hispanic     9     9     1     3     22  
American Indian     0     1     0     0     1  
Asian     0     1     0     0     1  
Unknown     1     2     0     1     4  



  Outcome Measures
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1.  Primary:   Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter   [ Time Frame: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24) ]

2.  Secondary:   Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter   [ Time Frame: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24) ]

3.  Secondary:   Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)   [ Time Frame: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24) ]

4.  Secondary:   Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)   [ Time Frame: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24) ]

5.  Secondary:   Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter   [ Time Frame: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24) ]

6.  Secondary:   Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter   [ Time Frame: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24) ]

7.  Secondary:   Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)   [ Time Frame: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24) ]

8.  Secondary:   Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)   [ Time Frame: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24) ]

9.  Secondary:   Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter   [ Time Frame: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24) ]

10.  Secondary:   Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter   [ Time Frame: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24) ]

11.  Secondary:   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)   [ Time Frame: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24) ]

12.  Secondary:   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)   [ Time Frame: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24) ]

13.  Secondary:   Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period   [ Time Frame: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) ]

14.  Secondary:   Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period   [ Time Frame: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) ]

15.  Secondary:   Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period   [ Time Frame: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00402363     History of Changes
Other Study ID Numbers: OM8 Afib
Study First Received: November 20, 2006
Results First Received: September 23, 2010
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration