We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention Of Recurrence Of Atrial Fibrillation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00041496
First Posted: July 12, 2002
Last Update Posted: August 11, 2014
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Fibrillation, Atrial Drug: SB-207266 Other: Placebo Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

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

Enrollment: 520
Study Start Date: November 2001
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00041496


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00041496     History of Changes
Other Study ID Numbers: 207266082
First Submitted: July 9, 2002
First Posted: July 12, 2002
Last Update Posted: August 11, 2014
Last Verified: August 2014

Keywords provided by GlaxoSmithKline:
symptomatic atrial fibrillation
persistent atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes