6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD)
Withdrawn before enrolling · Phase 3
Conditions studied: Generalized Anxiety Disorder
In brief
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 the treatment of elderly subjects with Generalized Anxiety Disorder (GAD).
Key facts
- Study ID
- NCT00738738
- Run by
- Pfizer
- People needed
- 0
- Starts
- 2009-01-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2012-12-03
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — Orlando, Florida, United States
- Pfizer Investigational Site — Prairie Village, Kansas, United States
Full record on ClinicalTrials.gov
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