NCT00658008

A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1)

A Phase 3, Randomized, Double-Blind, Parallel Group, 10-Week Placebo Controlled Fixed Dose Study Of PD 0332334 And Paroxetine Evaluating The Efficacy And Safety Of PD 0332334 For The Treatment Of Generalized Anxiety Disorder

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages from 18 to 65, with generalized anxiety disorder.

Detailed description

Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	PD 0332334	Capsules, oral, 175 mg BID, 8 weeks with 2 week taper
DRUG	PD 0332334	Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
DRUG	PD 0332334	Capsules, oral, 75 mg BID, 8 weeks with 2 week taper
DRUG	Paroxetine	Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper
DRUG	Placebo	Capsules, oral, placebo bid, 8 weeks with 2 week taper

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-04-14
• Last updated: 2012-11-16

Locations

52 sites across 5 countries: United States, Hungary, Italy, Russia, South Korea