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TTP889

Phase 2

Venous Thromboembolism | Small molecule | Cardiovascular |vTv Therapeutics Inc.|Last Updated: Jun 3, 2009

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 Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00119457Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)PHASE2 COMPLETED 300 — — Jan 1, 2005Apr 1, 2006Jun 3, 200921 Czechia, Denmark +2
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Study Endpoints
Primary Endpoints
To evaluate the antithrombotic efficacy of TTP889, administered once daily for three weeks, in patients who have completed standard prophylactic treatment for deep vein thrombosis after hip fracture surgery.
Evaluation of safety of once daily oral administration of TTP889 for three weeks
Secondary Endpoints
To assess the correlation between peak and trough plasma concentrations of TTP889 and clinical safety and efficacy outcomes.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
TTP889DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Must have undergone reparative surgery within 72 hours after unilateral hip fracture, defined as fracture of the upper third of either femur * Must have started standard prophylactic treatment for VTE with low molecular weight heparin (LMWH) or heparin before surgery or within...

Countries:CzechiaDenmarkNorwaySweden
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