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Please see Detailed Description for termination reason.
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This is an open-label, multi-site, 6-month study of an investigational compound in elderly outpatients, age 65 years old or above, to assess the long-term safety and tolerability of the compound in the treatment of elderly subjects with Generalized Anxiety Disorder (GAD).
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 from: 50-100 mg oral capsule Dosage and frequency: 50-350 mg once or twice a day Duration: 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication | Weekly | |
| The nature, incidence, duration, and severity of adverse events. | Weekly | |
| Suicide related adverse events will be further assessed using the Columbia Suicide Severity Rating Scale as needed | As needed | |
| The primary outcome is safety which will be assessed throughout the 6-months by physical exams, monitoring of vital signs, body weight changes, and clinical safety laboratory | Screening, Baseline, Wk 4, Wk 14, Wk 26/EOT, & at FU; Vital signs at every vist | |
| Electrocardiograms will be performed to assess any changes in cardiac functioning related to the compound | Screening, Baseline, Wk 4, Wk 15 & Wk 26/EOT |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom severity of generalized Anxiety Disorder (GAD) will be measured by the Hamilton Rating Scale for Anxiety (HAM-A). | Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT & Wk 27 (FU) | |
| Overall Health Care utilization will be assessed with the Health Care Utilization (HCU) questionnaire. |
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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 | Orlando | Florida | 32806 | 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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| 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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| Twice at Wk 13 and Wk 26/EOT |
| Also, the Daily Diary (including the Daily assessment of Symptoms DAS-A and Global Anxiety - Visual Analog Scale (GA-VAS) and the Clinical Global Impression of Severity (CGI-S) will be used to assess symptoms of GAD. | Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT |
| Plasma concentrations will be collected to evaluate the population pharmacokinetics and the dose/exposure relationships for safety and efficacy . | 1 time |
| Prairie Village |
| Kansas |
| 66206 |
| United States |