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

NCT00738738 | Withdrawn Phase 3

• 1 other identifier: A5361036
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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).

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder Elderly

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

Interventions

PD-0332334 DRUG

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

Also known as: imagabalin

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Orlando, Florida, 32806, United States

Location

Pfizer Investigational Site

Prairie Village, Kansas, 66206, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

imagabalin

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 20, 2008
• Study Start: January 1, 2009
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

US (2)