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SB-207266

Phase 2

Fibrillation, Atrial | Small molecule | Other |GSK plc|Last Updated: Aug 11, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment520
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00041496Prevention Of Recurrence Of Atrial FibrillationPHASE2 COMPLETED 520Nov 1, 2001Dec 1, 2003Aug 11, 2014 -
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Study Endpoints
Primary Endpoints
Time-to-first symptomatic AF (atrial fibrillation)
Up to 26 Weeks
Secondary Endpoints
Time to first symptomatic or detected asymptomatic AF; spontaneous reversion to sinus rhythm prior to cardioversion
Up to 26 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTALPatients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or placebo
Arm 2PLACEBO_COMPARATORPatients with Symptomatic Persistent Atrial Fibrillation (AF) will be randomized with either SB207266 or Placebo
Interventions
NameTypeDescription
SB-207266DRUGWhite, oval, biconvex tablets containing either 10mg, 25mg or 40mg
PlaceboOTHERPlacebo to match SB-207266
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

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 criter...

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