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Please see Detailed Description for termination reason.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD 0332334 175 mg BID | Experimental |
| |
| PD 0332334 225 mg BID | Experimental |
| |
| PD 0332334 75 mg BID | Experimental |
| |
| Paroxetine 20 mg QD | Active Comparator |
| |
| Placebo BID | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD 0332334 | Drug | Capsules, oral, 175 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 |
|---|---|---|
| Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ) | 8 weeks | |
| Response rate on the patient-rated PGI-C at week 8 | 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 | Litchfield Park | Arizona | 85340 | 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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| PD 0332334 | Drug | Capsules, oral, 225 mg BID, 8 weeks with 2 week taper |
|
| PD 0332334 | Drug | Capsules, oral, 75 mg BID, 8 weeks with 2 week taper |
|
| Paroxetine | Drug | Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper |
|
| Placebo | Drug | Capsules, oral, placebo bid, 8 weeks with 2 week taper |
|
| Change from baseline to week 8 on the Sheehan Disability Scale subscales |
| 8 weeks |
| Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13) | 8 weeks |
| Response rate on the HAM-A at week 1 and week 8 | 8 weeks |
| Response rate on the clinician-rated CGI-I ate week 1 and 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 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II | 1 week |
| Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II | 8 weeks |
| Change from baseline in the 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 Medical Outcomes Study Sleep Scale subscales | 8 weeks |
| Remission rate based on the HAM A at Week 8 | 8 weeks |
| Change from baseline in CGI-S at week 8 | 8 weeks |
| Change from baseline to week 8 in the QLesQ General Activity Score | 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 to Days 2 8 and Weeks 2, 4, 6, 8 on the DAS A (total score) | 8 weeks |
| 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 and 8 on the GA-VAS (diary) | 8 weeks |
| Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score | 8 weeks |
| Costa Mesa |
| California |
| 92626 |
| United States |
| Pfizer Investigational Site | Pasadena | California | 91106 | United States |
| Pfizer Investigational Site | Redlands | California | 92374 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80239 | United States |
| Pfizer Investigational Site | Norwich | Connecticut | 06360 | United States |
| Pfizer Investigational Site | Altamonte Springs | Florida | 32701 | 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 | South Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Terre Haute | Indiana | 47802 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | Topeka | Kansas | 66606 | United States |
| Pfizer Investigational Site | Shreveport | Louisiana | 71104 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21208 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02135 | United States |
| Pfizer Investigational Site | Saint Charles | Missouri | 63301 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89146 | United States |
| Pfizer Investigational Site | Clementon | New Jersey | 08021 | United States |
| Pfizer Investigational Site | Willingboro | New Jersey | 08046 | 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 | The Bronx | New York | 10454 | United States |
| Pfizer Investigational Site | The Bronx | New York | 10467 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27607 | 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 | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Pfizer Investigational Site | Media | Pennsylvania | 19063 | United States |
| Pfizer Investigational Site | Norristown | Pennsylvania | 19401 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19136 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29201 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38117 | United States |
| Pfizer Investigational Site | Austin | Texas | 78756 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75231 | United States |
| Pfizer Investigational Site | Lake Jackson | Texas | 77566 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Burlington | Vermont | 05401 | United States |
| Pfizer Investigational Site | Charlottesville | Virginia | 22903 | United States |
| Pfizer Investigational Site | Charlottesville | Virginia | 22911 | United States |
| Pfizer Investigational Site | Waukesha | Wisconsin | 53188-1660 | United States |
| Pfizer Investigational Site | Budapest | 1095 | Hungary |
| Pfizer Investigational Site | Budapest | 1137 | Hungary |
| Pfizer Investigational Site | Catania | 95123 | Italy |
| Pfizer Investigational Site | Torino | 10126 | Italy |
| Pfizer Investigational Site | Khotkovo, Moscow Region | 142601 | Russia |
| Pfizer Investigational Site | Seoul | 135-710 | South Korea |
| Pfizer Investigational Site | Seoul | 138-736 | South Korea |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C583768 | imagabalin |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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