Status:
WITHDRAWN
6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD)
Lead Sponsor:
Pfizer
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
This is an open-label, multi-site, 6-month study of an investigational compound in elderly outpatients, age 65 years old or above, to assess the long-term safety and tolerability of the compound in th...
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
- Men or women age \> 65 years.
- A primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual-IV (DSM-IV).
- Subjects must have a HAM-A score of 16 or higher at both screening and baseline visits.
Exclusion
- Women who are pregnant or contemplating pregnancy (eg, via in vitro fertilization) during the study through 30 days after the last dose of study medication.
- Subjects with evidence of a current (within the past 6 months) clinically significant or unstable hematological, autoimmune, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, immunological or retinal disorder; subjects with an active infection within the past 2 months.
- Subjects who have an ongoing, unresolved, clinically significant cardiovascular or cerebrovascular medical problem.
- Mini Mental Status Exam (MMSE) score \<24 or possibility of undiagnosed dementia, cognitive or amnestic disorder, including, but not limited to mild cognitive impairment.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00738738
Start Date
January 1 2009
End Date
February 1 2009
Last Update
December 3 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Orlando, Florida, United States, 32806
2
Pfizer Investigational Site
Prairie Village, Kansas, United States, 66206