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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00738738 |
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).
Condition | Intervention | Phase |
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Generalized Anxiety Disorder |
Drug: PD-0332334 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase 3, 6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder |
Estimated Enrollment: | 100 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Not Specified: Experimental
Not Specified
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Drug: PD-0332334
Dosage from: 50-100 mg oral capsule Dosage and frequency: 50-350 mg once or twice a day Duration: 6 months
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Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, Connecticut | |
Pfizer Investigational Site | |
Hamden, Connecticut, United States, 06518 | |
United States, New York | |
Pfizer Investigational Site | |
White Plains, New York, United States, 10605 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A5361036 |
Study First Received: | August 12, 2008 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00738738 |
Health Authority: | United States: Food and Drug Administration |
Generalized Anxiety Disorder
Elderly |
Anxiety Disorders Mental Disorders |
Pathologic Processes Disease |