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

1. prosince 2016 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

663

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Placebo
Lék: Placebo
Experimentální: omega-3-acid ethyl esters
Lék: omega-3-acid ethyl esters

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

GlaxoSmithKline

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. listopadu 2006

Primární dokončení (Aktuální)

1. ledna 2010

Dokončení studie (Aktuální)

1. ledna 2010

Termíny zápisu do studia

První předloženo

20. listopadu 2006

První předloženo, které splnilo kritéria kontroly kvality

20. listopadu 2006

První zveřejněno (Odhad)

22. listopadu 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

30. ledna 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. prosince 2016

Naposledy ověřeno

1. prosince 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • OM8 Afib

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ano

Popis plánu IPD

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

Studijní data/dokumenty

  1. Formulář informovaného souhlasu
    Identifikátor informace: OM8 Afib
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  2. Soubor dat jednotlivých účastníků
    Identifikátor informace: OM8 Afib
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formulář komentované zprávy o případu
    Identifikátor informace: OM8 Afib
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  4. Specifikace datové sady
    Identifikátor informace: OM8 Afib
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protokol studie
    Identifikátor informace: OM8 Afib
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  6. Plán statistické analýzy
    Identifikátor informace: OM8 Afib
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  7. Zpráva o klinické studii
    Identifikátor informace: OM8 Afib
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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