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CP-533, 536

Phase 2

Tibial Fractures | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Feb 17, 2012

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 Enrollment276
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00533377ACTiF- Assessment of Closed Tibial FracturesPHASE2 COMPLETED 276 — — Jan 1, 2008May 1, 2010Feb 17, 201256 United States, Australia +9
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Study Endpoints
Primary Endpoints
Time to fracture healing compared with placebo
24 weeks
Secondary Endpoints
Proportion of subjects who require a secondary intervention to promote fracture healing
48 weeks
Impact on the subject's ability to return to normal function, general health status, work productivity, and degree of pain at fracture site compared with placebo and Standard of Care groups
24 weeks
Time to fracture healing compared with Standard of Care
24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CP-533,536 Dose Level 2EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Standard of CareOTHER -
CP-533,536 Dose Level 1EXPERIMENTAL -
CP-533,536 Dose Level 3EXPERIMENTAL -
CP-533.536 Dose Level 4EXPERIMENTAL -
Interventions
NameTypeDescription
CP-533, 536DRUGActive study drug
PlaceboDRUGPlacebo vehicle
Standard of CarePROCEDUREStandard surgical procedure
CP-533,536DRUGActive study drug
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Eligibility Criteria
Age Range17 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites56

Inclusion Criteria: * Males or females 17 years or older with confirmed closure of the tibial epiphyses, with a closed fracture of the tibial diaphysis undergoing treatment with reamed locked IM nailing procedure and the absence of an associated compartment syndrome or vascular injury; * Closed tib...

Countries:United StatesAustraliaBosnia and HerzegovinaCanadaCroatiaIndiaJapanRussiaSouth AfricaSpainTurkey (Türkiye)
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