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PD 0348292

Phase 2

Venous Thrombosis | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 10, 2007

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 Enrollment1,225
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00306254Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee SurgeryPHASE2 COMPLETED 1,225 — — Mar 1, 2006Jul 1, 2007Oct 10, 2007134 United States, Australia +14
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Study Endpoints
Primary Endpoints
The primary efficacy endpoint is the incidence of total venous thromboembolism (including all proximal and distal deep vein thrombosis [DVT] and pulmonary embolism [PE])
The primary safety endpoint is the incidence of total bleeding.
Secondary Endpoints
Secondary efficacy endpoints are incidence of proximal DVT, distal DVT, and PE.
Secondary safety endpoints are incidence of major and minor bleeding, all-cause mortality, abnormal liver function test elevation, adverse events and serious adverse events, and changes in clinical laboratory parameters.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
PD 0348292DRUG -
EnoxaparinDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites134

Inclusion Criteria: * Adult men or women scheduled for an elective, unilateral total knee replacement who are otherwise healthy. Exclusion Criteria: * History of deep vein thrombosis or pulmonary embolism, suspected postthrombotic state, bleeding or clotting disorders, or cardiovascular, renal or...

Countries:United StatesAustraliaCanadaChileColombiaCzechiaDenmarkFranceItalyPolandPortugalRussiaSlovakiaSouth AfricaSpainUnited Kingdom
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