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PF-3463275

Phase 1

Schizophrenia | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Oct 2, 2008

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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00567203A Study Of Adjunctive Treatment Of Cognitive Deficits In SchizophreniaPHASE1 COMPLETED 36Nov 1, 2007May 1, 2008Oct 2, 20082 United States
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Study Endpoints
Primary Endpoints
Change from baseline in the CNS Vital Signs Cognition Battery composite score
6 days
Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's.
38 days
Pharmacokinetics of PF-3463275
6 days
Secondary Endpoints
Positive and Negative Syndrome Scale (PANSS)
6 days
Change from baseline in the CNS Vital Signs Cognition Battery domain scores
6 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-3463275DRUGPF-3463275 10mg
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Diagnosis of schizophrenia * In stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months * Stable symptoms of schizophrenia for at least 3 months. Exclusion Criteria: * Subjects with a psychiatric disorder ot...

Countries:United States
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