Prevention Of Recurrence Of Atrial Fibrillation

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Fibrillation, Atrial

Treatments: Drug: SB-207266; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00041496

207266082

Details and patient eligibility

About

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).

Enrollment: 520 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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520 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Description:

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

Treatment:

Drug: SB-207266

Arm 2

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo