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Clinical Trials/NCT00041496
NCT00041496
Completed
Phase 2

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)

GlaxoSmithKline0 sites520 target enrollmentNovember 2001

Overview

Phase
Phase 2
Intervention
SB-207266
Conditions
Fibrillation, Atrial
Sponsor
GlaxoSmithKline
Enrollment
520
Primary Endpoint
Time-to-first symptomatic AF (atrial fibrillation)
Status
Completed
Last Updated
11 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 2001
End Date
December 2003
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

Arm 1

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

Intervention: SB-207266

Arm 2

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

Intervention: Placebo

Outcomes

Primary Outcomes

Time-to-first symptomatic AF (atrial fibrillation)

Time Frame: Up to 26 Weeks

Secondary Outcomes

  • Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion(Up to 26 Weeks)

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