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

Phase 3

Withdrawn

• Conditions: Generalized Anxiety Disorder

• Registration Number: NCT00738738
• Lead Sponsor: Pfizer

Brief Summary

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).

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: 2008-08-18
• Study First Posted: 2008-08-20
• Study Start: 2009-01
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication	Weekly
The nature, incidence, duration, and severity of adverse events.	Weekly
Suicide related adverse events will be further assessed using the Columbia Suicide Severity Rating Scale as needed	As needed
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	Screening, Baseline, Wk 4, Wk 14, Wk 26/EOT, & at FU; Vital signs at every vist
Electrocardiograms will be performed to assess any changes in cardiac functioning related to the compound	Screening, Baseline, Wk 4, Wk 15 & Wk 26/EOT

Secondary Outcome Measures

Name	Time	Method
Symptom severity of generalized Anxiety Disorder (GAD) will be measured by the Hamilton Rating Scale for Anxiety (HAM-A).	Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT & Wk 27 (FU)
Overall Health Care utilization will be assessed with the Health Care Utilization (HCU) questionnaire.	Twice at Wk 13 and Wk 26/EOT
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.	Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT
Plasma concentrations will be collected to evaluate the population pharmacokinetics and the dose/exposure relationships for safety and efficacy .	1 time

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Prairie Village, Kansas, United States