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

Phase 3

Terminated

• Conditions: Generalized Anxiety Disorder

• Registration Number: NCT00735267
• Lead Sponsor: Pfizer

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-08-12
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Study Start: 2008-10
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Disposition First Submitted: 2010-08-25
• Disposition First Submitted QC: 2010-08-25
• Disposition First Posted: 2010-08-30
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-09
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 468

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Waukesha, Wisconsin, United States