Prevention Of Recurrence Of Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00041496
First received: July 9, 2002
Last updated: August 7, 2014
Last verified: August 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

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
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, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00041496     History of Changes
Other Study ID Numbers: 207266082
Study First Received: July 9, 2002
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
symptomatic atrial fibrillation
persistent atrial fibrillation

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

ClinicalTrials.gov processed this record on August 18, 2014