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Prevention Of Recurrence Of Atrial Fibrillation

Primary Purpose

Fibrillation, Atrial

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SB-207266
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fibrillation, Atrial focused on measuring symptomatic atrial fibrillation, persistent atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Arm 1

    Arm 2

    Arm Description

    Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or placebo

    Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or Placebo

    Outcomes

    Primary Outcome Measures

    Time-to-first symptomatic AF (atrial fibrillation)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 9, 2002
    Last Updated
    August 7, 2014
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00041496
    Brief Title
    Prevention Of Recurrence Of Atrial Fibrillation
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2001 (undefined)
    Primary Completion Date
    December 2003 (Actual)
    Study Completion Date
    December 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibrillation, Atrial
    Keywords
    symptomatic atrial fibrillation, persistent atrial fibrillation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    520 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Description
    Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or placebo
    Arm Title
    Arm 2
    Arm Type
    Placebo Comparator
    Arm Description
    Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    SB-207266
    Intervention Description
    White, oval, biconvex tablets containing either 10mg, 25mg or 40mg
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo to match SB-207266
    Primary Outcome Measure Information:
    Title
    Time-to-first symptomatic AF (atrial fibrillation)
    Time Frame
    Up to 26 Weeks
    Secondary Outcome Measure Information:
    Title
    Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion
    Time Frame
    Up to 26 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

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