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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: December 1, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Fibrillation, Atrial
Drug: omega-3-acid ethyl esters
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ]
    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.


Secondary Outcome Measures:
  • 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) ]
    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.

  • 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) ]
    A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.

  • 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) ]
    A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.

  • 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) ]
    A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.

  • 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) ]
    A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.

  • 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) ]
    A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.

  • 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) ]
    A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.

  • 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) ]
    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. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter.

  • 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) ]
    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. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter.

  • 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) ]
    A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.

  • 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) ]
    A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.

  • 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) ]
    Rescue was defined as any pharmacological/electrical/surgical intervention for the termination/prevention of AF/flutter with a maximum of one rescue episode counted per day. Note: all annualized values were calculated by counting the number of rescue episodes, dividing by the number of days on treatment, then multiplying that number by 365.25.

  • 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) ]
    Values were annualized by counting the number of episodes of symptomatic AF/flutter recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.

  • 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) ]
    Values were annualized by counting the number of episodes of symptomatic AF recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.


Enrollment: 663
Study Start Date: November 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: omega-3-acid ethyl esters Drug: omega-3-acid ethyl esters
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402363

  Show 178 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: OM8 Afib
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: OM8 Afib
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: OM8 Afib
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: OM8 Afib
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: OM8 Afib
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: OM8 Afib
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: OM8 Afib
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: December 1, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Lovaza
Omega-3 fatty acids
Omacor
Paroxysmal atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2017