Last updated: 11/03/2018 23:55:56

Prevention Of Recurrence Of Atrial Fibrillation

GSK study ID
207266082
Clinicaltrials.gov ID
NCT00041496
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Safety and Efficacy of SB 207266 in Patients with Symptomatic Persistent Atrial Fibrillation (AF)
Trial description: The purpose of this study is to determine whether the study drug is effective in preventing the recurrence of atrial fibrillation (an abnormal heart rhythm).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Time-to-first symptomatic AF (atrial fibrillation)

Timeframe: Up to 26 Weeks

Secondary outcomes:

Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion

Timeframe: Up to 26 Weeks

Interventions:
  • Drug: SB-207266
  • Other: Placebo
    • Enrollment:
    520
    Primary completion date:
    2003-31-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Fibrillation, Atrial
    Product
    piboserod
    Collaborators
    Not applicable
    Study date(s)
    November 2001 to December 2003
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Symptomatic persistent atrial fibrillation requiring DC cardioversion.
    • Duration of AF >48 hrs. <6 months
    • Concomitant Class I and/or III anti-arrhythmic drugs.
    • Amiodarone treatment within 3 months of the study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Symptomatic persistent atrial fibrillation requiring DC cardioversion.
    • Duration of AF >48 hrs. <6 months
    Exclusion criteria:
    • Concomitant Class I and/or III anti-arrhythmic drugs.
    • Amiodarone treatment within 3 months of the study.
    • Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    2003-31-12
    Actual study completion date
    2003-31-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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