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

NCT00836069 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-08-21

No results posted yet for this study

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).

Conditions

  • Anxiety Disorders

Interventions

DRUG

No drug name provided by Sponsor; drug referenced as PD 0332334

Experimental study drug for generalized anxiety disorder, oral tablet, at a total daily dose of 450mg or 600mg, twice daily for 8 weeks and then 2 weeks of dose tapering.

DRUG

Paroxetine

FDA Approved medication for generalized anxiety disorder, oral tablet, at 20mg, once daily for 8 weeks and then 2 weeks of dose tapering.

DRUG

Placebo

inactive substance, oral tablet, once per day, for 10 weeks.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Cedars-Sinai Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-02-28
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00836069 on ClinicalTrials.gov