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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00542685 |
This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.
Condition | Intervention | Phase |
---|---|---|
Generalized Anxiety Disorder |
Drug: PD 0332334 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group, 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder |
Estimated Enrollment: | 548 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
PD 0332334 300 mg BID: Experimental |
Drug: PD 0332334
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
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Placebo BID: Placebo Comparator |
Drug: Placebo
Capsules, oral, placebo BID, 8 weeks with 2 week taper.
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PD 0332334 225 mg BID: Experimental |
Drug: PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
|
PD 0332334 175 mg BID: Experimental |
Drug: PD 0332334
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A5361017 |
Study First Received: | October 10, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00542685 |
Health Authority: | United States: Food and Drug Administration |
Anxiety Disorders Mental Disorders |
Pathologic Processes Disease |