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)

Prevention Of Recurrence Of Atrial Fibrillation

Sponsors

Lead sponsor: GlaxoSmithKline

Source 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).

Overall Status Completed
Start Date November 2001
Completion Date December 2003
Primary Completion Date December 2003
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Time-to-first symptomatic AF (atrial fibrillation) Up to 26 Weeks
Secondary Outcome
Measure Time Frame
Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion Up to 26 Weeks
Enrollment 520
Condition
Intervention

Intervention type: Drug

Intervention name: SB-207266

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

Arm group label: Arm 1

Intervention type: Other

Intervention name: Placebo

Description: Placebo to match SB-207266

Arm group label: Arm 2

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
GSK Clinical Trials Study Director GlaxoSmithKline
Verification Date

August 2014

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Arm 1

Arm group type: Experimental

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

Arm group label: Arm 2

Arm group type: Placebo Comparator

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov