Status:
TERMINATED
A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)
Lead Sponsor:
Pfizer
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study will assess the long-term safety and tolerability of 350 to 600 mg/day of PD 0332334 administered in split dose (twice daily) in subjects 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 base...
Eligibility Criteria
Inclusion
- Subjects must have completed all phases of one of the four preceding double-blind GAD studies.
- Female must continue to use adequate birth control methods and have a negative serum pregnancy test within 14 days prior to starting open label treatment.
Exclusion
- Subjects who experienced a serious adverse event during the preceding double-blind efficacy study that was judged to be related to study medication by the investigator or the sponsor's medical monitor.
- Individuals who have an ongoing, unresolved, clinically significant medical problem that, in the judgment of the investigator or the sponsor's medical monitor, would make it unsafe for the subject to participate in the study.
- Serious suicidal risk per the clinical investigators's judgement.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT00735267
Start Date
October 1 2008
End Date
April 1 2009
Last Update
November 16 2012
Active Locations (93)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35226
2
Pfizer Investigational Site
Litchfield Park, Arizona, United States, 85340
3
Pfizer Investigational Site
Arcadia, California, United States, 91007-3462
4
Pfizer Investigational Site
Beverly Hills, California, United States, 90210