A Phase 3 interventional study of PD 0332334 in Generalized Anxiety Disorder, sponsored by Pfizer. Terminated at 93 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-11-16.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 468 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dosage Form: 25 or 100 mg oral capsules Dosage and frequency: 350-600 mg twice a day Duration: 1 year
Also known as: imagabalin
The nature, incidence, and duration of adverse events monitored throughout the study by physical exam
Time frame: 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
Time frame: Screening, Wk 4, Wk 25, Wk 52/EOT
The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events
Time frame: 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
Time frame: 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
Time frame: Weekly
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Wk 12, Wk 25, Wk 38 & Wk 51
This study is terminated, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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