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6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD)

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Orlando, Florida, 32806 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Generalized Anxiety Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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 cognitive or amnestic disorder, including, but not limited to mild cognitive
impairment.

NCT00738738
Pfizer
Withdrawn
6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD)

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[email protected]

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