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

1 grudnia 2016 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

663

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
Lek: Placebo
Eksperymentalny: omega-3-acid ethyl esters
Lek: omega-3-acid ethyl esters

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

GlaxoSmithKline

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 listopada 2006

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2010

Ukończenie studiów (Rzeczywisty)

1 stycznia 2010

Daty rejestracji na studia

Pierwszy przesłany

20 listopada 2006

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 listopada 2006

Pierwszy wysłany (Oszacować)

22 listopada 2006

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

30 stycznia 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 grudnia 2016

Ostatnia weryfikacja

1 grudnia 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • OM8 Afib

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAk

Opis planu IPD

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

Badanie danych/dokumentów

  1. Formularz świadomej zgody
    Identyfikator informacji: OM8 Afib
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  2. Indywidualny zestaw danych uczestnika
    Identyfikator informacji: OM8 Afib
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formularz zgłoszenia przypadku z adnotacjami
    Identyfikator informacji: OM8 Afib
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  4. Specyfikacja zestawu danych
    Identyfikator informacji: OM8 Afib
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protokół badania
    Identyfikator informacji: OM8 Afib
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  6. Plan analizy statystycznej
    Identyfikator informacji: OM8 Afib
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  7. Raport z badania klinicznego
    Identyfikator informacji: OM8 Afib
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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