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PD 0332334

Phase 3

Generalized Anxiety Disorder | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Nov 16, 2012

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_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment779
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00542685A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety DisorderPHASE3 COMPLETED 551 — — Oct 1, 2007Dec 1, 2008Nov 16, 201243 United States
NCT00921063A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety DisorderPHASE2 COMPLETED 222 — — Nov 1, 2005Jul 1, 2006Feb 19, 2010 - —
NCT00537615An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male VolunteersPHASE1 COMPLETED 6 — — Sep 1, 2007Oct 1, 2007Feb 17, 20101 United States
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Study Endpoints
Primary Endpoints
The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment.
8 weeks
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study.
8 weeks
HAM-A Total Score
4 weeks
Radioactivity parameters in plasma and whole blood - Cmax , Tmax , AUCinf, AUClast, t1/2, CL/F and V/F.
Total 14C data in blood, urine and feces
Ratio of radioactivity in red blood cells to plasma (RBC/plasma)
Cumulative recovery of radioactivity in urine and feces
Identification of metabolites in feces, plasma and urine if possible
Plasma, urine and fecal PD 0332334 pharmacokinetic parameters - Cmax, Tmax, AUClast, AUCinf, t1/2, CL/F, V/F, CLR, Ae24 and Ae24(%)
Secondary Endpoints
Response rate on the clinician-rated CGI-I at Week 1 and Week 8.
8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales.
8 weeks
Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score.
8 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PD 0332334 300 mg BIDEXPERIMENTAL -
Placebo BIDPLACEBO_COMPARATOR -
PD 0332334 225 mg BIDEXPERIMENTAL -
PD 0332334 175 mg BIDEXPERIMENTAL -
PD 0332334 250 mgEXPERIMENTAL -
PD 0332334 100 mgEXPERIMENTAL -
placeboPLACEBO_COMPARATOR -
Alprazolam extended releaseACTIVE_COMPARATOR -
Interventions
NameTypeDescription
PD 0332334DRUGCapsules, oral, 300 mg BID, 8 weeks with 2 week taper.
PlaceboDRUGCapsules, oral, placebo BID, 8 weeks with 2 week taper.
Alprazolam extended releaseDRUG1 mg capsule, BID for 4 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites43

Inclusion Criteria: * Diagnosis of GAD (Diagnostic and Statistical Manual-IV \[DSM-IV\], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MI...

Countries:United States
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