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Please see Detailed Description for termination reason.
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This study will assess the long-term safety and tolerability of 350 to 600 mg/day of PD 0332334 administered in split dose (twice daily) in subjects with Generalized Anxiety Disorder.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD 0332334 | Drug | Dosage Form: 25 or 100 mg oral capsules Dosage and frequency: 350-600 mg twice a day Duration: 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| The nature, incidence, and duration of adverse events monitored throughout the study by physical exam | Screening, Wk 25 & Wk 52/EOT | |
| Electrocardiogram will be performed at screening and during follow up visits to assess the safety and tolerability of the compound in terms of clinically significant cardiovascular changes | Screening, Wk 4, Wk 25, Wk 52/EOT | |
| The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events | As needed | |
| The nature, incidence, and duration of adverse events monitored throughout the study by vital signs evaluation at each visit, weight measurements and clinical laboratory monitoring periodically | Screening, Baseline, Wk 4, Wk 12, Wk 25, Wk 38, & Wk 52/EOT | |
| All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound | Weekly |
| Measure | Description | Time Frame |
|---|---|---|
| The Hamilton Rating Scale for Anxiety (HAM-A) will be used to assess symptoms of Generalized Anxiety Disorder (GAD) over a one year time period. | Baseline, Wk 12, Wk 25, Wk 38, Wk 51 & Wk 52/EOT | |
| The Clinical Global Impression of Severity (CGI-S), and the Daily Diary (DD) will also be used to assess symptoms of GAD over a one year time period. |
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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 | Birmingham | Alabama | 35226 | 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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| Baseline, Wk 51 & Wk 52/EOT |
| The Health Care Utilization Questionnaire will be utilized to assess overall Health Care over a one year time period. | Baseline, Wk 12, Wk 25, Wk 38 & Wk 51 |
| Litchfield Park |
| Arizona |
| 85340 |
| United States |
| Pfizer Investigational Site | Arcadia | California | 91007-3462 | United States |
| Pfizer Investigational Site | Beverly Hills | California | 90210 | United States |
| Pfizer Investigational Site | Costa Mesa | California | 92626 | United States |
| Pfizer Investigational Site | Costa Mesa | California | 92627 | United States |
| Pfizer Investigational Site | Encino | California | 91316 | United States |
| Pfizer Investigational Site | Escondido | California | 92025 | United States |
| Pfizer Investigational Site | Murrieta | California | 92562 | United States |
| Pfizer Investigational Site | National City | California | 91950 | United States |
| Pfizer Investigational Site | Newport Beach | California | 92660-2452 | United States |
| Pfizer Investigational Site | Orange | California | 92868 | United States |
| Pfizer Investigational Site | Pasadena | California | 91106 | United States |
| Pfizer Investigational Site | Redlands | California | 92374 | United States |
| Pfizer Investigational Site | San Diego | California | 92103 | United States |
| Pfizer Investigational Site | San Diego | California | 92108 | United States |
| Pfizer Investigational Site | Sherman Oaks | California | 91403 | United States |
| Pfizer Investigational Site | Temecula | California | 92591 | United States |
| Pfizer Investigational Site | Upland | California | 91786 | United States |
| Pfizer Investigational Site | Wildomar | California | 92595 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80239 | United States |
| Pfizer Investigational Site | Hamden | Connecticut | 06518 | United States |
| Pfizer Investigational Site | Norwich | Connecticut | 06360 | United States |
| Pfizer Investigational Site | Altamonte Springs | Florida | 32701 | United States |
| Pfizer Investigational Site | Fort Myers | Florida | 33912 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32216 | United States |
| Pfizer Investigational Site | Maitland | Florida | 32751 | United States |
| Pfizer Investigational Site | Miami | Florida | 33126 | United States |
| Pfizer Investigational Site | Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Orange City | Florida | 32763 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32806 | United States |
| Pfizer Investigational Site | South Miami | Florida | 33143 | 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 | Naperville | Illinois | 60563 | United States |
| Pfizer Investigational Site | Park Ridge | Illinois | 60068 | United States |
| Pfizer Investigational Site | Greenwood | Indiana | 46143 | United States |
| Pfizer Investigational Site | Terre Haute | Indiana | 47802 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | Prairie Village | Kansas | 66206 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67207 | United States |
| Pfizer Investigational Site | Owensboro | Kentucky | 42301 | United States |
| Pfizer Investigational Site | Lake Charles | Louisiana | 70601 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21208 | United States |
| Pfizer Investigational Site | Belmont | Massachusetts | 02478 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02135 | United States |
| Pfizer Investigational Site | Fall River | Massachusetts | 02721 | United States |
| Pfizer Investigational Site | Haverhill | Massachusetts | 01830 | United States |
| Pfizer Investigational Site | Pittsfield | Massachusetts | 01201 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68131 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89146 | United States |
| Pfizer Investigational Site | Nashua | New Hampshire | 03060 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| Pfizer Investigational Site | Brooklyn | New York | 11235 | United States |
| Pfizer Investigational Site | New York | New York | 10023 | United States |
| Pfizer Investigational Site | New York | New York | 10024 | United States |
| Pfizer Investigational Site | New York | New York | 10128-1708 | United States |
| Pfizer Investigational Site | Rochester | New York | 14618 | United States |
| Pfizer Investigational Site | The Bronx | New York | 10467 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27607 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43210 | United States |
| Pfizer Investigational Site | Dayton | Ohio | 45408 | United States |
| Pfizer Investigational Site | Toledo | Ohio | 43609 | United States |
| Pfizer Investigational Site | Toledo | Ohio | 43623 | United States |
| Pfizer Investigational Site | Bethany | Oklahoma | 73008 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73116 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97210 | United States |
| Pfizer Investigational Site | Salem | Oregon | 97301 | United States |
| Pfizer Investigational Site | Allentown | Pennsylvania | 18104 | United States |
| Pfizer Investigational Site | Media | Pennsylvania | 19063 | United States |
| Pfizer Investigational Site | Norristown | Pennsylvania | 19401 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19139 | United States |
| Pfizer Investigational Site | Lincoln | Rhode Island | 02865 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29201 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38119 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38134 | United States |
| Pfizer Investigational Site | Austin | Texas | 78756 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75231 | United States |
| Pfizer Investigational Site | DeSoto | Texas | 75115 | United States |
| Pfizer Investigational Site | Houston | Texas | 77008 | United States |
| Pfizer Investigational Site | Houston | Texas | 77074 | United States |
| Pfizer Investigational Site | Lake Jackson | Texas | 77566 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Woodstock | Vermont | 05091 | United States |
| Pfizer Investigational Site | Charlottesville | Virginia | 22903 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98104 | United States |
| Pfizer Investigational Site | Middleton | Wisconsin | 53562 | United States |
| Pfizer Investigational Site | Waukesha | Wisconsin | 53188-1660 | 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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