COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Prevention Of Recurrence Of Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00041496
Recruitment Status : Completed
First Posted : July 12, 2002
Last Update Posted : August 11, 2014
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Fibrillation, Atrial Drug: SB-207266 Other: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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)
Study Start Date : November 2001
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1
Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or placebo
Drug: SB-207266
White, oval, biconvex tablets containing either 10mg, 25mg or 40mg

Placebo Comparator: Arm 2
Patients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or Placebo
Other: Placebo
Placebo to match SB-207266

Primary Outcome Measures :
  1. Time-to-first symptomatic AF (atrial fibrillation) [ Time Frame: Up to 26 Weeks ]

Secondary Outcome Measures :
  1. Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion [ Time Frame: Up to 26 Weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00041496

Sponsors and Collaborators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Layout table for additonal information
Responsible Party: GlaxoSmithKline Identifier: NCT00041496    
Other Study ID Numbers: 207266082
First Posted: July 12, 2002    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014
Keywords provided by GlaxoSmithKline:
symptomatic atrial fibrillation
persistent atrial fibrillation
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes