drugset / Trial / NCT00836069

Fixed Dose Study of PD 0332334 and Paroxetine for the Treatment of Generalized Anxiety Disorder

NCT00836069

Phase 3 Terminated 5 enrolled Cedars-Sinai Medical Center Pfizer · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a randomized, double-blind, parallel-group, multi-site, Phase 3, placebo controlled fixed-dose study of PD 0332334 and paroxetine in 528 outpatients with generalized anxiety disorder. Subjects will be randomized to the following treatments (132 subjects per treatment group): PD 0332334 225 mg twice a day (450 mg/day), PD 0332334 300 mg twice a day (600 mg/day), placebo once a day in the morning or paroxetine 20 mg once a day in the morning (20 mg/day).

Timeline

Start
2008-10
Primary completion
2009-02
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject IMAGABALIN Other / unclassified 225 mg Oral
Subject IMAGABALIN Other / unclassified 300 mg Oral
Comparator Paroxetine Small molecule 20 mg Oral

Indications