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Prevention Of Recurrence Of Atrial Fibrillation

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)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00041496
Enrollment
520
Registered
2002-07-12
Start date
2001-11-30
Completion date
2003-12-31
Last updated
2014-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrillation, Atrial

Keywords

symptomatic atrial fibrillation, persistent atrial fibrillation

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).

Interventions

DRUGSB-207266

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

OTHERPlacebo

Placebo to match SB-207266

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time-to-first symptomatic AF (atrial fibrillation)Up to 26 Weeks

Secondary

MeasureTime frame
Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversionUp to 26 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026