NCT00041496

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2002

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

August 11, 2014

Status Verified

August 1, 2014

Enrollment Period

2.1 years

First QC Date

July 9, 2002

Last Update Submit

August 7, 2014

Conditions

Fibrillation, Atrial

Keywords

symptomatic atrial fibrillationpersistent atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • Time-to-first symptomatic AF (atrial fibrillation)

    Up to 26 Weeks

Secondary Outcomes (1)

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

    Up to 26 Weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Drug: SB-207266

Arm 2

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

SB-207266DRUG

White, oval, biconvex tablets containing either 10mg, 25mg or 40mg

Arm 1
PlaceboOTHER

Placebo to match SB-207266

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic persistent atrial fibrillation requiring DC cardioversion.
  • Duration of AF \>48 hrs. \<6 months

You may not qualify if:

  • Concomitant Class I and/or III anti-arrhythmic drugs.
  • Amiodarone treatment within 3 months of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

SB 207266

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2002

First Posted

July 12, 2002

Study Start

November 1, 2001

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

August 11, 2014

Record last verified: 2014-08