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

Pfizer

Status and phase

Withdrawn

Phase 3

Conditions

Generalized Anxiety Disorder

Treatments

Drug: PD-0332334

Study type

Interventional

Funder types

Industry

Identifiers

NCT00738738

A5361036

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.