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PD 0332334

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment779

FDA Designations

No designations recorded

Clinical trial landscape

PD 0332334 · 3 trials · 1 indication

Phase 3 1Phase 2 1Phase 1 1
NCT00542685A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety DisorderGeneralized Anxiety Disorder
COMPLETED551 Analytics
PHASE3COMPLETED
A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder
Generalized Anxiety DisorderUnlock trial analytics

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 to 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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Frequently asked questions about PD 0332334

What is PD 0332334 used for?

PD 0332334 is an investigational small molecule being developed for Generalized Anxiety Disorder and studied in patients receiving renal dialysis. It has been evaluated in Phase 1, Phase 2, and Phase 3 clinical trials, all of which are completed. The drug is not approved and remains in clinical development.

Who makes PD 0332334?

PD 0332334 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company has sponsored multiple clinical trials of the drug, including a Phase 3 study in Generalized Anxiety Disorder.

What phase is PD 0332334 in?

PD 0332334 has completed Phase 3 clinical development. A 10-week Phase 3 study evaluated its efficacy and safety in Generalized Anxiety Disorder, and a Phase 2 trial compared it with alprazolam extended release and placebo. The drug is investigational and not FDA approved.

What clinical trials is PD 0332334 in?

PD 0332334 has completed three clinical trials: NCT00537615, a Phase 1 absorption, metabolism, and excretion study in healthy volunteers; NCT00542685, a Phase 3 efficacy and safety study in Generalized Anxiety Disorder; and NCT00730145, a Phase 1 study in hemodialysis patients. All trials are completed.

Is PD 0332334 the same as PD-0332334?

PD 0332334 and PD-0332334 refer to the same investigational drug. Clinical trial records use both spellings, with NCT00730145 titled 'PD-0332334' and other studies using 'PD 0332334'. Both names identify the same Pfizer compound.