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VFENDÂ I.V.,

Phase 3

Candidiasis | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 26, 2011

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment412
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00163111A Clinical Study Intended To Compare Treatment With Voriconazole To Treatment With Amphotericin Followed By Fluconazole In Patients With Candidemia, A Serious Fungus Infection Of The Blood.PHASE3 COMPLETED 412Sep 1, 1998May 1, 2003Apr 26, 2011 -
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Study Endpoints
Primary Endpoints
Sustained clinical response for 12 weeks from end of treatment
Secondary Endpoints
Time to negative blood cultures
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
VFEND® I.V., OralDRUG -
Conventional amphotericin BDRUG -
Diflucan IV, oralDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients with candidemia Exclusion Criteria: * Neutropenia

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