이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2016년 12월 1일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

663

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
의약품: 위약
실험적: omega-3-acid ethyl esters
의약품: omega-3-acid ethyl esters

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2006년 11월 1일

기본 완료 (실제)

2010년 1월 1일

연구 완료 (실제)

2010년 1월 1일

연구 등록 날짜

최초 제출

2006년 11월 20일

QC 기준을 충족하는 최초 제출

2006년 11월 20일

처음 게시됨 (추정)

2006년 11월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2017년 1월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 12월 1일

마지막으로 확인됨

2016년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • OM8 Afib

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

연구 데이터/문서

  1. 정보에 입각한 동의서
    정보 식별자: OM8 Afib
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  2. 개별 참가자 데이터 세트
    정보 식별자: OM8 Afib
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  3. 주석이 달린 사례 보고서 양식
    정보 식별자: OM8 Afib
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  4. 데이터 세트 사양
    정보 식별자: OM8 Afib
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  5. 연구 프로토콜
    정보 식별자: OM8 Afib
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  6. 통계 분석 계획
    정보 식별자: OM8 Afib
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  7. 임상 연구 보고서
    정보 식별자: OM8 Afib
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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