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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00735267

Purpose

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.

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: PD 0332334	Phase III

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder

Further study details as provided by Pfizer:

Primary Outcome Measures:

The nature, incidence, and duration of adverse events monitored throughout the study by physical exam [ Time Frame: Screening, Wk 25 & Wk 52/EOT ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events [ Time Frame: As needed ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	October 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Dosage Form: 25 or 100 mg oral capsules Dosage and frequency: 350-600 mg twice a day Duration: 1 year

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735267

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 76 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5361022
Study First Received:	August 12, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00735267
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Generalized Anxiety Disorder

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009