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

1. Dezember 2016 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

663

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Arzneimittel: Placebo
Experimental: omega-3-acid ethyl esters
Arzneimittel: omega-3-acid ethyl esters

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2006

Primärer Abschluss (Tatsächlich)

1. Januar 2010

Studienabschluss (Tatsächlich)

1. Januar 2010

Studienanmeldedaten

Zuerst eingereicht

20. November 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. November 2006

Zuerst gepostet (Schätzen)

22. November 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

30. Januar 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Dezember 2016

Zuletzt verifiziert

1. Dezember 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • OM8 Afib

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiendaten/Dokumente

  1. Einwilligungserklärung
    Informationskennung: OM8 Afib
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  2. Einzelner Teilnehmerdatensatz
    Informationskennung: OM8 Afib
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  3. Kommentiertes Fallberichtsformular
    Informationskennung: OM8 Afib
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datensatzspezifikation
    Informationskennung: OM8 Afib
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  5. Studienprotokoll
    Informationskennung: OM8 Afib
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistischer Analyseplan
    Informationskennung: OM8 Afib
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  7. Klinischer Studienbericht
    Informationskennung: OM8 Afib
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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