Prevention Of Recurrence Of Atrial Fibrillation

Phase 2

Completed

• Conditions: Fibrillation, Atrial
• Interventions: Other: Placebo; Drug: SB-207266

• Registration Number: NCT00041496
• Lead Sponsor: GlaxoSmithKline

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2002-07-09
• Study First Submitted QC: 2002-07-11
• Study First Posted: 2002-07-12
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-07
• Last Update Posted: 2014-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo	Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or Placebo
Arm 1	SB-207266	Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or placebo

Primary Outcome Measures

Name	Time	Method
Time-to-first symptomatic AF (atrial fibrillation)	Up to 26 Weeks

Secondary Outcome Measures

Name	Time	Method
Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion	Up to 26 Weeks