Last updated: 11/03/2018 23:55:56
Prevention Of Recurrence Of Atrial Fibrillation
GSK study ID
207266082
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Time-to-first symptomatic AF (atrial fibrillation)
Timeframe: Up to 26 Weeks
Secondary outcomes:
Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion
Timeframe: Up to 26 Weeks
Interventions:
Drug: SB-207266
Other: Placebo
Enrollment:
520
Observational study model:
Not applicable
Primary completion date:
2003-31-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Fibrillation, Atrial
Product
piboserod
Collaborators
Not applicable
Study date(s)
November 2001 to December 2003
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Symptomatic persistent atrial fibrillation requiring DC cardioversion.
- Duration of AF >48 hrs. <6 months
- Concomitant Class I and/or III anti-arrhythmic drugs.
- Amiodarone treatment within 3 months of the study.
Inclusion and exclusion 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.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2003-31-12
Actual study completion date
2003-31-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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