Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

1. december 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

663

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Eksperimentel: omega-3-acid ethyl esters
Medicin: omega-3-acid ethyl esters

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2006

Primær færdiggørelse (Faktiske)

1. januar 2010

Studieafslutning (Faktiske)

1. januar 2010

Datoer for studieregistrering

Først indsendt

20. november 2006

Først indsendt, der opfyldte QC-kriterier

20. november 2006

Først opslået (Skøn)

22. november 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OM8 Afib

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

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

Studiedata/dokumenter

  1. Formular til informeret samtykke
    Informations-id: OM8 Afib
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individuelt deltagerdatasæt
    Informations-id: OM8 Afib
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annoteret sagsbetænkningsformular
    Informations-id: OM8 Afib
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datasætspecifikation
    Informations-id: OM8 Afib
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Studieprotokol
    Informations-id: OM8 Afib
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistisk analyseplan
    Informations-id: OM8 Afib
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Klinisk undersøgelsesrapport
    Informations-id: OM8 Afib
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner