6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD) - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00738738

Purpose

This is an open-label, multi-site, 6-month study of an investigational compound in elderly outpatients, age 65 years old or above, to assess the long-term safety and tolerability of the compound in the treatment of elderly subjects with Generalized Anxiety Disorder (GAD).

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 Phase 3, 6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder

Further study details as provided by Pfizer:

Primary Outcome Measures:

Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
The nature, incidence, duration, and severity of adverse events. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
Suicide related adverse events will be further assessed using the Columbia Suicide Severity Rating Scale as needed [ Time Frame: As needed ] [ Designated as safety issue: Yes ]
The primary outcome is safety which will be assessed throughout the 6-months by physical exams, monitoring of vital signs, body weight changes, and clinical safety laboratory [ Time Frame: Screening, Baseline, Wk 4, Wk 14, Wk 26/EOT, & at FU; Vital signs at every vist ] [ Designated as safety issue: Yes ]
Electrocardiograms will be performed to assess any changes in cardiac functioning related to the compound [ Time Frame: Screening, Baseline, Wk 4, Wk 15 & Wk 26/EOT ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Symptom severity of generalized Anxiety Disorder (GAD) will be measured by the Hamilton Rating Scale for Anxiety (HAM-A). [ Time Frame: Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT & Wk 27 (FU) ] [ Designated as safety issue: No ]
Overall Health Care utilization will be assessed with the Health Care Utilization (HCU) questionnaire. [ Time Frame: Twice at Wk 13 and Wk 26/EOT ] [ Designated as safety issue: No ]
Also, the Daily Diary (including the Daily assessment of Symptoms DAS-A and Global Anxiety - Visual Analog Scale (GA-VAS) and the Clinical Global Impression of Severity (CGI-S) will be used to assess symptoms of GAD. [ Time Frame: Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT ] [ Designated as safety issue: No ]
Plasma concentrations will be collected to evaluate the population pharmacokinetics and the dose/exposure relationships for safety and efficacy . [ Time Frame: 1 time ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Not Specified: Experimental Not Specified	Drug: PD-0332334 Dosage from: 50-100 mg oral capsule Dosage and frequency: 50-350 mg once or twice a day Duration: 6 months

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men or women age > 65 years.
A primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual-IV (DSM-IV).
Subjects must have a HAM-A score of 16 or higher at both screening and baseline visits.

Exclusion Criteria:

Women who are pregnant or contemplating pregnancy (eg, via in vitro fertilization) during the study through 30 days after the last dose of study medication.
Subjects with evidence of a current (within the past 6 months) clinically significant or unstable hematological, autoimmune, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, immunological or retinal disorder; subjects with an active infection within the past 2 months.
Subjects who have an ongoing, unresolved, clinically significant cardiovascular or cerebrovascular medical problem.
Mini Mental Status Exam (MMSE) score <24 or possibility of undiagnosed dementia, cognitive or amnestic disorder, including, but not limited to mild cognitive impairment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738738

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United States, Connecticut
Pfizer Investigational Site
Hamden, Connecticut, United States, 06518
United States, New York
Pfizer Investigational Site
White Plains, New York, United States, 10605

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:	A5361036
Study First Received:	August 12, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00738738
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Generalized Anxiety Disorder Elderly

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