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SB-424323

Phase 2

Arthroplasty | Small molecule | Other |GSK plc|Last Updated: May 30, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment343
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00041509ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)PHASE2 COMPLETED 343Jan 1, 2002May 1, 2003May 30, 2017 -
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Study Endpoints
Primary Endpoints
VTE
28 day treatment period

Incidence of VTE during the 28-day treatment period, including death due to VTE

Secondary Endpoints
types of VTE
28 day treatment period
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
SB424323, 500 mg BIDEXPERIMENTAL -
SB424323, 125 mg BIDEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
SB-424323DRUG500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days
PlaceboDRUGmatching placebo, oral, BID for 28 days
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Eligibility Criteria
Age Range35 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side). * Patients who have given written informed consent to participate in this study. Exclusion Criteria: * Patients with a contraindicatio...

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