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

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00738738
• Other study ID #: A5361036
• Status: Withdrawn
• Phase: Phase 3
• First received: August 12, 2008
• Last updated: November 30, 2012
• Start date: January 2009
• Est. completion date: February 2009

Study information

• Verified date: November 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• PD-0332334
Dosage from: 50-100 mg oral capsule Dosage and frequency: 50-350 mg once or twice a day Duration: 6 months

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Prairie Village	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication		Weekly	Yes
Primary	The nature, incidence, duration, and severity of adverse events.		Weekly	Yes
Primary	Suicide related adverse events will be further assessed using the Columbia Suicide Severity Rating Scale as needed		As needed	Yes
Primary	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	Yes
Primary	Electrocardiograms will be performed to assess any changes in cardiac functioning related to the compound		Screening, Baseline, Wk 4, Wk 15 & Wk 26/EOT	Yes
Secondary	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)	No
Secondary	Overall Health Care utilization will be assessed with the Health Care Utilization (HCU) questionnaire.		Twice at Wk 13 and Wk 26/EOT	No
Secondary	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	No
Secondary	Plasma concentrations will be collected to evaluate the population pharmacokinetics and the dose/exposure relationships for safety and efficacy .		1 time	No

External Links

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