A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Drug: PD 0332334


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have completed all phases of one of the four preceding double-blind GAD studies. Female must continue to use adequate birth control methods and have a negative serum pregnancy test within 14 days prior to starting open label treatment. Exclusion Criteria: Subjects who experienced a serious adverse event during the preceding double-blind efficacy study that was judged to be related to study medication by the investigator or the sponsor's medical monitor. Individuals who have an ongoing, unresolved, clinically significant medical problem that, in the judgment of the investigator or the sponsor's medical monitor, would make it unsafe for the subject to participate in the study. Serious suicidal risk per the clinical investigators's judgement.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PD 0332334|Dosage Form: 25 or 100 mg oral capsules Dosage and frequency: 350-600 mg twice a day Duration: 1 year|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Anxiety Disorder