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This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD 0332334 300 mg BID | Experimental |
| |
| Placebo BID | Placebo Comparator |
| |
| PD 0332334 225 mg BID | Experimental |
| |
| PD 0332334 175 mg BID | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD 0332334 | Drug | Capsules, oral, 300 mg BID, 8 weeks with 2 week taper. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment. | 8 weeks | |
| The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate on the clinician-rated CGI-I at Week 1 and Week 8. | 8 weeks | |
| Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales. | 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Beverly Hills | California | 90210 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo | Drug | Capsules, oral, placebo BID, 8 weeks with 2 week taper. |
|
| PD 0332334 | Drug | Capsules, oral, 225 mg BID, 8 weeks with 2 week taper. |
|
| PD 0332334 | Drug | Capsules, oral, 175 mg BID, 8 weeks with 2 week taper. |
|
| Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score. |
| 8 weeks |
| Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score). | 8 weeks |
| Response rate on the HAM-A at Week 1 and Week 8. | 8 weeks |
| Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8. | 8 weeks |
| Remission rate based on the HAM-A at Week 1 and Week 8. | 8 weeks |
| Response rate on the patient-rated PGI-C at Week 8. | 8 weeks |
| The "Week 1 Sustained Responder" rate based on the HAM-A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM-A total score at Week 1 that is sustained until the Week 8 visit). | 1 week |
| Change from Baseline in HAM-A total score at Weeks 1, 2, 4, and 6. | 6 weeks |
| Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8. | 8 weeks |
| Change from Baseline to Week 8 on the Sheehan Disability Scale subscales. | 8 weeks |
| Change from Baseline in CGI-S at Week 8. | 8 weeks |
| Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8. | 8 weeks |
| Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score. | 8 weeks |
| Change from Baseline to Week 8 in the Q-Les-Q General Activities Score. | 8 weeks |
| Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score. | 1 week |
| Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary). | 8 weeks |
| Encino |
| California |
| 91316 |
| United States |
| Pfizer Investigational Site | National City | California | 91950 | United States |
| Pfizer Investigational Site | Newport Beach | California | 92660-2452 | United States |
| Pfizer Investigational Site | San Diego | California | 92103 | United States |
| Pfizer Investigational Site | Sherman Oaks | California | 91403 | United States |
| Pfizer Investigational Site | Farmington | Connecticut | 06030-6415 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32216 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32256-2006 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32806 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33613 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33407 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30308 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30328 | United States |
| Pfizer Investigational Site | Marietta | Georgia | 30060 | United States |
| Pfizer Investigational Site | Libertyville | Illinois | 60048 | United States |
| Pfizer Investigational Site | Schaumburg | Illinois | 60194 | United States |
| Pfizer Investigational Site | Lafayette | Indiana | 47905 | United States |
| Pfizer Investigational Site | Owensboro | Kentucky | 42301 | United States |
| Pfizer Investigational Site | Lake Charles | Louisiana | 70601 | United States |
| Pfizer Investigational Site | Glen Burnie | Maryland | 21061 | United States |
| Pfizer Investigational Site | Rockville | Maryland | 20852 | United States |
| Pfizer Investigational Site | Belmont | Massachusetts | 02478 | United States |
| Pfizer Investigational Site | Fall River | Massachusetts | 02721 | United States |
| Pfizer Investigational Site | Farmington Hills | Michigan | 48336 | United States |
| Pfizer Investigational Site | Nashua | New Hampshire | 03060 | United States |
| Pfizer Investigational Site | Cherry Hill | New Jersey | 08002 | United States |
| Pfizer Investigational Site | Piscataway | New Jersey | 08854-5635 | United States |
| Pfizer Investigational Site | Brooklyn | New York | 11201 | United States |
| Pfizer Investigational Site | New York | New York | 10024 | United States |
| Pfizer Investigational Site | Staten Island | New York | 10312 | United States |
| Pfizer Investigational Site | Chapel Hill | North Carolina | 27514 | United States |
| Pfizer Investigational Site | Durham | North Carolina | 27710 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43210 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97210 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19139 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19149 | United States |
| Pfizer Investigational Site | Lincoln | Rhode Island | 02865 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29407 | United States |
| Pfizer Investigational Site | Houston | Texas | 77057 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23230 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98104 | United States |
| Pfizer Investigational Site | Middleton | Wisconsin | 53562 | United States |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C583768 | imagabalin |
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