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OpenTrials
Completed

NCT Number: NCT00402363

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

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.

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Key information

Conditions

Fibrillation, Atrial Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3-Acid Ethyl Esters

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Nov 22, 2006
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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