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Sponsored by: |
Pfizer |
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00658762 |
This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects ages 18 and older with generalized anxiety disorder.
Condition | Intervention | Phase |
Generalized Anxiety Disorder |
Drug: PD 0332334 Drug: paroxetine Drug: Placebo |
Phase III |
MedlinePlus related topics: | Anxiety |
ChemIDplus related topics: | Paroxetine Paroxetine hydrochloride Paroxetine Mesylate |
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, Parallel Group, 10-Week Placebo Controlled Fixed Dose Study of PD 0332334 and Paroxetine Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder |
Estimated Enrollment: | 528 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (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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Paroxetine 20 mg q am: Active Comparator |
Drug: paroxetine
Capsules, oral, 20 mg q am, 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
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Placebo BID: Placebo Comparator |
Drug: Placebo
Capsules, oral, 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 |
Show 28 Study Locations |
Pfizer |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
To obtain contact information for a study center near you, click here. 
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Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A5361020 |
First Received: | April 9, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00658762 |
Health Authority: | United States: Food and Drug Administration |
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