|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00658008 |
Purpose
This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages from 18 to 65, with generalized anxiety disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Generalized Anxiety Disorder |
Drug: PD 0332334 Drug: Paroxetine Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, 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 |
| Enrollment: | 501 |
| Study Start Date: | April 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| PD 0332334 175 mg BID: Experimental |
Drug: PD 0332334
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper
|
| PD 0332334 225 mg BID: Experimental |
Drug: PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
|
| PD 0332334 75 mg BID: Experimental |
Drug: PD 0332334
Capsules, oral, 75 mg BID, 8 weeks with 2 week taper
|
| Paroxetine 20 mg QD: Active Comparator |
Drug: Paroxetine
Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper
|
| Placebo BID: Placebo Comparator |
Drug: Placebo
Capsules, oral, placebo bid, 8 weeks with 2 week taper
|
Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study.
The decision to terminate this study was not based on any safety concerns.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 52 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A5361019 |
| Study First Received: | April 8, 2008 |
| Last Updated: | June 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00658008 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
PD 0332334 phase 3 pivotal trial |
|
Neurotransmitter Agents Anxiety Disorders Mental Disorders Psychotropic Drugs Antidepressive Agents, Second-Generation |
Serotonin Uptake Inhibitors Paroxetine Antidepressive Agents Serotonin |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Paroxetine Serotonin Uptake Inhibitors Pharmacologic Actions |
Pathologic Processes Serotonin Agents Anxiety Disorders Mental Disorders Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |