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Prevention Of Recurrence Of Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT00041496
Recruitment Status : Completed
First Posted : July 12, 2002
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
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).

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

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

U.S. FDA Resources

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 ]


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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.

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00041496     History of Changes
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:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes