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PF-03654764

Phase 2

Allergic Rhinitis | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 17, 2010

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 Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01033396The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic RhinitisPHASE2 COMPLETED 64Jan 1, 2010May 1, 2010Aug 17, 20101 Canada
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Study Endpoints
Primary Endpoints
Congestion scores
6 hours
Other allergic rhinitis symptoms
6 hours
Secondary Endpoints
Pharmacokinetics
6 hours
Blood pressure/pulse rate
6 hours
Adverse event reporting
2 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-03654764 + AllegraEXPERIMENTAL -
PF-03654764EXPERIMENTAL -
Allegra-DACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-03654764DRUGPF-03654764 single dose 5 mg
AllegraDRUGFexofenadine single dose 60 mg
Allegra-DDRUGFexofenadine 60 mg combined with pseudoephedrine 120 mg single dose
PlaceboDRUGPlacebo single dose
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female subjects 18-60 years allergic to ragweed pollen. * Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit. Exclusion Criteria: * Subjects with significant diseases other than allergic rhinitis that may interfe...

Countries:Canada
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Competitive Landscape -Allergic Rhinitis 4 trials