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SR123781A

Phase 2

Venous Thromboembolism | Small molecule | Cardiovascular |Sanofi|Last Updated: Dec 10, 2008

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment1,090
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00338897Dose Ranging Study in Elective Total Hip Replacement SurgeryPHASE2 COMPLETED 1,090 — — May 1, 2006May 1, 2007Dec 10, 200814 Argentina, Bulgaria +12
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Study Endpoints
Primary Endpoints
The primary efficacy endpoint is a composite of total venous thromboembolic events (VTE) including VTE related deaths during the treatment period.
Secondary Endpoints
Secondary efficacy endpoints will include all deep vein thrombosis events [DVTs] (proximal or distal) and all symptomatic VTEs (pulmonary embolisms [PEs] or DVTs)
The main safety criterion is the incidence of major bleedings occurring from the first study drug administration to 3 calendar days after the last study drug administration.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
SR123781ADRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Patients scheduled to undergo elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed \> 6 months prior to study entry Exclusion Criteria: * Pregnant or nursing women, or women of childbearing potential who are not ...

Countries:ArgentinaBulgariaChileColombiaCzechiaDenmarkFinlandMexicoNorwayPolandRomaniaRussiaSwedenTurkey (Türkiye)
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