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

December 1, 2016 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

663

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • GSK Investigational Site
      • Huntsville, Alabama, United States, 35801
        • GSK Investigational Site
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • GSK Investigational Site
    • Arizona
      • Cottonwood, Arizona, United States, 86326
        • GSK Investigational Site
      • Mesa, Arizona, United States, 85206
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85006
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85032
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85014
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85724
        • GSK Investigational Site
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • GSK Investigational Site
      • Hot Springs, Arkansas, United States, 71913
        • GSK Investigational Site
    • California
      • Alamada, California, United States, 94501
        • GSK Investigational Site
      • Bakersfield, California, United States, 93301
        • GSK Investigational Site
      • Bakersfield, California, United States, 93308
        • GSK Investigational Site
      • Beverly Hills, California, United States, 90210
        • GSK Investigational Site
      • Carmichael, California, United States, 95608
        • GSK Investigational Site
      • Fair Oaks, California, United States, 95628
        • GSK Investigational Site
      • Fountain Valley, California, United States, 92708
        • GSK Investigational Site
      • Loma Linda, California, United States, 92354
        • GSK Investigational Site
      • Los Angeles, California, United States, 90073
        • GSK Investigational Site
      • Los Angeles, California, United States, 90048
        • GSK Investigational Site
      • Los Angeles, California, United States, 90033
        • GSK Investigational Site
      • Los Angeles, California, United States, 90211
        • GSK Investigational Site
      • Merced, California, United States, 95348
        • GSK Investigational Site
      • Palm Springs, California, United States, 92262
        • GSK Investigational Site
      • Poway, California, United States, 92064
        • GSK Investigational Site
      • Redondo Beach, California, United States, 90277
        • GSK Investigational Site
      • Sacramento, California, United States, 95819
        • GSK Investigational Site
      • San Diego, California, United States, 92123
        • GSK Investigational Site
      • San Diego, California, United States, 92120
        • GSK Investigational Site
      • San Diego, California, United States, 92161
        • GSK Investigational Site
      • Vista, California, United States, 92081
        • GSK Investigational Site
      • Walnut Creek, California, United States, 94598
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • GSK Investigational Site
      • Colorado Springs, Colorado, United States, 80907
        • GSK Investigational Site
      • Littleton, Colorado, United States, 80120
        • GSK Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • GSK Investigational Site
      • Farmington, Connecticut, United States, 06030
        • GSK Investigational Site
      • Guilford, Connecticut, United States, 06437
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • GSK Investigational Site
      • Washington, District of Columbia, United States, 20017
        • GSK Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • GSK Investigational Site
      • Bay Pines, Florida, United States, 33744
        • GSK Investigational Site
      • Daytona Beach, Florida, United States, 32114
        • GSK Investigational Site
      • Delray Beach, Florida, United States, 33484
        • GSK Investigational Site
      • Fort Meyers, Florida, United States, 33919
        • GSK Investigational Site
      • Gainesville, Florida, United States, 32605
        • GSK Investigational Site
      • Hudson, Florida, United States, 34667
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32216
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32207
        • GSK Investigational Site
      • Jupiter, Florida, United States, 33458
        • GSK Investigational Site
      • Kissimmee, Florida, United States, 34741
        • GSK Investigational Site
      • Largo, Florida, United States, 33773
        • GSK Investigational Site
      • Melbourne, Florida, United States, 32901
        • GSK Investigational Site
      • Miami, Florida, United States, 33136
        • GSK Investigational Site
      • Miami, Florida, United States, 33137
        • GSK Investigational Site
      • Miami, Florida, United States, 33176
        • GSK Investigational Site
      • Ocala, Florida, United States, 34471
        • GSK Investigational Site
      • Orlando, Florida, United States, 32803
        • GSK Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • GSK Investigational Site
      • Pensacola, Florida, United States, 32514
        • GSK Investigational Site
      • Pinellas Park, Florida, United States, 33781
        • GSK Investigational Site
      • Tampa, Florida, United States, 33607
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30322
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30328
        • GSK Investigational Site
      • Decatur, Georgia, United States, 30030
        • GSK Investigational Site
      • Tucker, Georgia, United States, 30084
        • GSK Investigational Site
    • Illinois
      • Bannockburn, Illinois, United States, 60015
        • GSK Investigational Site
      • Gurnee, Illinois, United States, 60031
        • GSK Investigational Site
      • Normal, Illinois, United States, 61761
        • GSK Investigational Site
      • Peoria, Illinois, United States, 61603
        • GSK Investigational Site
    • Indiana
      • Elkhart, Indiana, United States, 46514
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • GSK Investigational Site
      • La Porte, Indiana, United States, 46350
        • GSK Investigational Site
      • South Bend, Indiana, United States, 46601
        • GSK Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66102
        • GSK Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • GSK Investigational Site
      • Mount Sterling, Kentucky, United States, 40353
        • GSK Investigational Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • GSK Investigational Site
      • Lacombe, Louisiana, United States, 70445
        • GSK Investigational Site
    • Maine
      • Auburn, Maine, United States, 04210
        • GSK Investigational Site
      • Biddeford, Maine, United States, 04005
        • GSK Investigational Site
      • Portland, Maine, United States, 04106
        • GSK Investigational Site
      • Scarborough, Maine, United States, 04074
        • GSK Investigational Site
    • Maryland
      • Annapolis, Maryland, United States, 20401
        • GSK Investigational Site
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
        • GSK Investigational Site
      • Brookline, Massachusetts, United States, 02446
        • GSK Investigational Site
      • Worcester, Massachusetts, United States, 01655
        • GSK Investigational Site
    • Michigan
      • Alpena, Michigan, United States, 49707
        • GSK Investigational Site
      • Cadillac, Michigan, United States, 49601
        • GSK Investigational Site
      • Detroit, Michigan, United States, 48201
        • GSK Investigational Site
      • Kalamazoo, Michigan, United States, 49048
        • GSK Investigational Site
      • Lansing, Michigan, United States, 48910
        • GSK Investigational Site
    • Minnesota
      • Mineappolis, Minnesota, United States, 55417
        • GSK Investigational Site
      • Rochester Hills, Minnesota, United States, 48307
        • GSK Investigational Site
      • St Paul, Minnesota, United States, 55102
        • GSK Investigational Site
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • GSK Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • GSK Investigational Site
      • Kalispell, Montana, United States, 59901
        • GSK Investigational Site
      • Missoula, Montana, United States, 59802
        • GSK Investigational Site
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • GSK Investigational Site
      • Summit, New Jersey, United States, 07901
        • GSK Investigational Site
      • Wayne, New Jersey, United States, 07470
        • GSK Investigational Site
    • New York
      • Babylon, New York, United States, 11702
        • GSK Investigational Site
      • Buffalo, New York, United States, 14215
        • GSK Investigational Site
      • Buffalo, New York, United States, 14209
        • GSK Investigational Site
      • Mineola, New York, United States, 11501
        • GSK Investigational Site
      • New York, New York, United States, 10032
        • GSK Investigational Site
      • New York, New York, United States, 10025
        • GSK Investigational Site
      • New York, New York, United States, 10021
        • GSK Investigational Site
      • New York, New York, United States, 10029
        • GSK Investigational Site
      • Troy, New York, United States, 12180
        • GSK Investigational Site
      • West Islip, New York, United States, 11794
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28080
        • GSK Investigational Site
      • Hickory, North Carolina, United States, 28601
        • GSK Investigational Site
      • Statesville, North Carolina, United States, 28625
        • GSK Investigational Site
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44304
        • GSK Investigational Site
      • Bryan, Ohio, United States, 43506
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44106
        • GSK Investigational Site
      • Fairview Park, Ohio, United States, 44126
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, United States, 73104
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, United States, 73109
        • GSK Investigational Site
    • Oregon
      • Corvalis, Oregon, United States, 97330
        • GSK Investigational Site
      • Hillsboro, Oregon, United States, 97123-4117
        • GSK Investigational Site
      • Portland, Oregon, United States, 97220
        • GSK Investigational Site
      • Portland, Oregon, United States, 97223
        • GSK Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • GSK Investigational Site
      • Greensburg, Pennsylvania, United States, 15601
        • GSK Investigational Site
      • Hershey, Pennsylvania, United States, 17033
        • GSK Investigational Site
      • Langhorne, Pennsylvania, United States, 19047
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19102
        • GSK Investigational Site
      • Ridley Park, Pennsylvania, United States, 19078
        • GSK Investigational Site
      • West Chester, Pennsylvania, United States, 19380
        • GSK Investigational Site
      • Wynnewood, Pennsylvania, United States, 19096
        • GSK Investigational Site
      • Wyomissing, Pennsylvania, United States, 19610
        • GSK Investigational Site
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • GSK Investigational Site
      • Pawtucket, Rhode Island, United States, 02860
        • GSK Investigational Site
      • Westerly, Rhode Island, United States, 02891
        • GSK Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • GSK Investigational Site
      • Spartanburg, South Carolina, United States, 29302
        • GSK Investigational Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • GSK Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38120
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • GSK Investigational Site
      • Beaumont, Texas, United States, 77702
        • GSK Investigational Site
      • Corpus Christi, Texas, United States, 78404
        • GSK Investigational Site
      • Dallas, Texas, United States, 75230
        • GSK Investigational Site
      • Dallas, Texas, United States, 75231
        • GSK Investigational Site
      • Houston, Texas, United States, 77074
        • GSK Investigational Site
      • Houston, Texas, United States, 77090
        • GSK Investigational Site
      • Humble, Texas, United States, 77338
        • GSK Investigational Site
      • Lubbock, Texas, United States, 79410
        • GSK Investigational Site
      • McKinney, Texas, United States, 75069
        • GSK Investigational Site
      • Odessa, Texas, United States, 79761
        • GSK Investigational Site
      • Odessa, Texas, United States, 79764
        • GSK Investigational Site
      • Orange, Texas, United States, 77630
        • GSK Investigational Site
      • Tyler, Texas, United States, 75701
        • GSK Investigational Site
      • Waco, Texas, United States, 76712
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • GSK Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22204
        • GSK Investigational Site
      • Chesapeake, Virginia, United States, 23510
        • GSK Investigational Site
      • Galax, Virginia, United States, 24333
        • GSK Investigational Site
      • Richlands, Virginia, United States, 24641
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23249
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23294
        • GSK Investigational Site
      • Springfield, Virginia, United States, 22151
        • GSK Investigational Site
    • Washington
      • Burien, Washington, United States, 98166
        • GSK Investigational Site
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • GSK Investigational Site
    • Wisconsin
      • Beloit, Wisconsin, United States, 53511
        • GSK Investigational Site
      • Madison, Wisconsin, United States, 53792
        • GSK Investigational Site
      • Marshfield, Wisconsin, United States, 54449
        • GSK Investigational Site
      • Milwaukee, Wisconsin, United States, 53215
        • GSK Investigational Site
      • Wausau, Wisconsin, United States, 54401
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: omega-3-acid ethyl esters
Drug: omega-3-acid ethyl esters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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
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.
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
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.
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)
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.
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)
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.
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
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.
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
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.
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)
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.
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)
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.
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
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.
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
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.
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
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.
From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 20, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OM8 Afib

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Study Data/Documents

  1. Informed Consent Form
    Information identifier: OM8 Afib
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: OM8 Afib
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annotated Case Report Form
    Information identifier: OM8 Afib
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: OM8 Afib
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: OM8 Afib
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: OM8 Afib
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Clinical Study Report
    Information identifier: OM8 Afib
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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