Prevention Of Recurrence Of Atrial Fibrillation

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2007 by GlaxoSmithKline. Recruitment status was Active, not recruiting

First Received on July 9, 2002. Last Updated on July 31, 2007 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00041496

Purpose

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).

Condition	Intervention	Phase
Atrial Fibrillation	Drug: SB-207266	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
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)

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Time-to-first symptomatic AF (atrial fibrillation)

Secondary Outcome Measures:

Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion

Enrollment:	520
Study Start Date:	November 2001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041496

Show 144 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trial, MD

GlaxoSmithKline

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00041496 History of Changes
Other Study ID Numbers:	207266082
Study First Received:	July 9, 2002
Last Updated:	July 31, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

persistent atrial fibrillation
symptomatic atrial fibrillation

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012