Prevention Of Recurrence Of Atrial Fibrillation

Fibrillation, Atrial Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041496
• Other study ID #: 207266082
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2002
• Last updated: August 7, 2014
• Start date: November 2001
• Est. completion date: December 2003

Study information

• Verified date: August 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Fibrillation, Atrial

Intervention

Drug:
• SB-207266
White, oval, biconvex tablets containing either 10mg, 25mg or 40mg

Other:
• Placebo
Placebo to match SB-207266

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-to-first symptomatic AF (atrial fibrillation)		Up to 26 Weeks	No
Secondary	Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion		Up to 26 Weeks	No