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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00735267 |
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Date of registration:
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12/08/2008 |
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Primary sponsor: |
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Public title:
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A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)
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Scientific title:
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A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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468 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00735267 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Generalized Anxiety Disorder
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Intervention(s)
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Drug: PD 0332334
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Primary Outcome(s)
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All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound
[Time Frame: Weekly]
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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]
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The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events
[Time Frame: As needed]
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The nature, incidence, and duration of adverse events monitored throughout the study by physical exam
[Time Frame: Screening, Wk 25 & Wk 52/EOT]
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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]
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Secondary Outcome(s)
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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]
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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]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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