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SB424323

Phase 2

Fibrillation, Atrial | Small molecule | Cardiovascular |GSK plc|Last Updated: Jan 16, 2017

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment640
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00240643Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For StrokePHASE2 COMPLETED 640Nov 1, 2005Dec 1, 2006Jan 16, 2017116 United States, Argentina +23
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Study Endpoints
Primary Endpoints
Relationship between anti IIa (a biomarker)and the dose of SB424323.
Secondary Endpoints
Blood levels of SB424323 during the study. Number of strokes, transient ischemic attacks or systemic embolism during the study. Changes in laboratory tests during the study.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
SB424323DRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites116

Inclusion Criteria: * Patients with non valvular atrial fibrillation and any of the following: * \</= 60 years old with no heart disease. * 60 years old with heart disease but no risk factors. * \>/=60 years old and \</=75 years old with no risk factors and no heart disease. * Must be able to take ...

Countries:United StatesArgentinaBelgiumBrazilCanadaDenmarkEstoniaFranceGermanyGreeceHungaryIndiaItalyLatviaMexicoNetherlandsNew ZealandNorwayRomaniaSouth KoreaSpainSwedenTaiwanThailandUnited Kingdom
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