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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 18 to 65, with generalized anxiety disorder.
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 225 mg BID | Experimental |
| |
| PD 0332334 300 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, 225 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 |
|---|---|---|
| Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score | 8 weeks | |
| Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6 | 6 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 | Arcadia | California | 91007-3462 | 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, 300 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 Medical Outcomes Study Sleep Scale subscales |
| 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 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 Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score | 8 weeks |
| Response rate on the HAM-A at week 1 and week 8 | 8 weeks |
| Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score | 1 week |
| Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 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 in the somatic subscale score of the HAM-A (items 7 - 13) | 8 weeks |
| Change from baseline to week 8 in the QLesQ General Activity Score | 8 weeks |
| Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ) | 8 weeks |
| Remission rate based on the HAM A at Week 8 | 8 weeks |
| Response rate on the clinician-rated CGI-I ate week 1 and week 8 | 8 weeks |
| Change from baseline in CGI-S at week 8 | 8 weeks |
| Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary) | 8 weeks |
| Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score | 8 weeks |
| Costa Mesa |
| California |
| 92627 |
| United States |
| Pfizer Investigational Site | Escondido | California | 92025 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90048 | United States |
| Pfizer Investigational Site | San Diego | California | 92108 | United States |
| Pfizer Investigational Site | Hamden | Connecticut | 06518 | United States |
| Pfizer Investigational Site | Boca Raton | Florida | 33431 | United States |
| Pfizer Investigational Site | Honolulu | Hawaii | 96813 | United States |
| Pfizer Investigational Site | Naperville | Illinois | 60563 | United States |
| Pfizer Investigational Site | Park Ridge | Illinois | 60068 | United States |
| Pfizer Investigational Site | Prairie Village | Kansas | 66206 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | 70115 | United States |
| Pfizer Investigational Site | Haverhill | Massachusetts | 01830 | United States |
| Pfizer Investigational Site | Pittsfield | Massachusetts | 01201 | United States |
| Pfizer Investigational Site | Flint | Michigan | 48503 | United States |
| Pfizer Investigational Site | Flint | Michigan | 48532 | United States |
| Pfizer Investigational Site | Minneapolis | Minnesota | 55454 | United States |
| Pfizer Investigational Site | Saint Paul | Minnesota | 55101 | United States |
| Pfizer Investigational Site | New York | New York | 10128-1708 | United States |
| Pfizer Investigational Site | Olean | New York | 14760 | United States |
| Pfizer Investigational Site | Rochester | New York | 14618 | United States |
| Pfizer Investigational Site | Dayton | Ohio | 45408 | United States |
| Pfizer Investigational Site | Allentown | Pennsylvania | 18104 | United States |
| Pfizer Investigational Site | Bartlett | Tennessee | 38134 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38119 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | DeSoto | Texas | 75115 | United States |
| Pfizer Investigational Site | Houston | Texas | 77090 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84132 | United States |
| Pfizer Investigational Site | Budapest | 1212 | Hungary |
| Pfizer Investigational Site | Moscow | 125367 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 191180 | Russia |
| Pfizer Investigational Site | Tainan | 704 | Taiwan |
| 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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