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)
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).
Investigators
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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