A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)

November 9, 2012 updated by: Pfizer

A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder

This study will assess the long-term safety and tolerability of 350 to 600 mg/day of PD 0332334 administered in split dose (twice daily) in subjects with Generalized Anxiety Disorder.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

468

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35226
        • Pfizer Investigational Site
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Pfizer Investigational Site
    • California
      • Arcadia, California, United States, 91007-3462
        • Pfizer Investigational Site
      • Beverly Hills, California, United States, 90210
        • Pfizer Investigational Site
      • Costa Mesa, California, United States, 92626
        • Pfizer Investigational Site
      • Costa Mesa, California, United States, 92627
        • Pfizer Investigational Site
      • Encino, California, United States, 91316
        • Pfizer Investigational Site
      • Escondido, California, United States, 92025
        • Pfizer Investigational Site
      • Murrieta, California, United States, 92562
        • Pfizer Investigational Site
      • National City, California, United States, 91950
        • Pfizer Investigational Site
      • Newport Beach, California, United States, 92660-2452
        • Pfizer Investigational Site
      • Orange, California, United States, 92868
        • Pfizer Investigational Site
      • Pasadena, California, United States, 91106
        • Pfizer Investigational Site
      • Redlands, California, United States, 92374
        • Pfizer Investigational Site
      • San Diego, California, United States, 92108
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
      • Sherman Oaks, California, United States, 91403
        • Pfizer Investigational Site
      • Temecula, California, United States, 92591
        • Pfizer Investigational Site
      • Upland, California, United States, 91786
        • Pfizer Investigational Site
      • Wildomar, California, United States, 92595
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80239
        • Pfizer Investigational Site
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Pfizer Investigational Site
      • Norwich, Connecticut, United States, 06360
        • Pfizer Investigational Site
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Pfizer Investigational Site
      • Ft. Myers, Florida, United States, 33912
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • Maitland, Florida, United States, 32751
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33126
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33143
        • Pfizer Investigational Site
      • Orange City, Florida, United States, 32763
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32806
        • Pfizer Investigational Site
      • South Miami, Florida, United States, 33143
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30328
        • Pfizer Investigational Site
      • Marietta, Georgia, United States, 30060
        • Pfizer Investigational Site
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Pfizer Investigational Site
      • Naperville, Illinois, United States, 60563
        • Pfizer Investigational Site
      • Park Ridge, Illinois, United States, 60068
        • Pfizer Investigational Site
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Pfizer Investigational Site
      • Terre Haute, Indiana, United States, 47802
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Pfizer Investigational Site
      • Prairie Village, Kansas, United States, 66206
        • Pfizer Investigational Site
      • Wichita, Kansas, United States, 67207
        • Pfizer Investigational Site
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Pfizer Investigational Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Pfizer Investigational Site
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02135
        • Pfizer Investigational Site
      • Fall River, Massachusetts, United States, 02721
        • Pfizer Investigational Site
      • Haverhill, Massachusetts, United States, 01830
        • Pfizer Investigational Site
      • Pittsfield, Massachusetts, United States, 01201
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Pfizer Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, United States, 10467
        • Pfizer Investigational Site
      • Brooklyn, New York, United States, 11235
        • Pfizer Investigational Site
      • New York, New York, United States, 10023
        • Pfizer Investigational Site
      • New York, New York, United States, 10024
        • Pfizer Investigational Site
      • New York, New York, United States, 10128-1708
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14618
        • Pfizer Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Pfizer Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45408
        • Pfizer Investigational Site
      • Toledo, Ohio, United States, 43623
        • Pfizer Investigational Site
      • Toledo, Ohio, United States, 43609
        • Pfizer Investigational Site
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73103
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73116
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Pfizer Investigational Site
      • Salem, Oregon, United States, 97301
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Pfizer Investigational Site
      • Media, Pennsylvania, United States, 19063
        • Pfizer Investigational Site
      • Norristown, Pennsylvania, United States, 19401
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19139
        • Pfizer Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Pfizer Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38134
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • DeSoto, Texas, United States, 75115
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77008
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77074
        • Pfizer Investigational Site
      • Lake Jackson, Texas, United States, 77566
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Pfizer Investigational Site
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Pfizer Investigational Site
      • Waukesha, Wisconsin, United States, 53188-1660
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have completed all phases of one of the four preceding double-blind GAD studies.
  • Female must continue to use adequate birth control methods and have a negative serum pregnancy test within 14 days prior to starting open label treatment.

Exclusion Criteria:

  • Subjects who experienced a serious adverse event during the preceding double-blind efficacy study that was judged to be related to study medication by the investigator or the sponsor's medical monitor.
  • Individuals who have an ongoing, unresolved, clinically significant medical problem that, in the judgment of the investigator or the sponsor's medical monitor, would make it unsafe for the subject to participate in the study.
  • Serious suicidal risk per the clinical investigators's judgement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The nature, incidence, and duration of adverse events monitored throughout the study by physical exam
Time Frame: Screening, Wk 25 & Wk 52/EOT
Screening, Wk 25 & Wk 52/EOT
Electrocardiogram will be performed at screening and during follow up visits to assess the safety and tolerability of the compound in terms of clinically significant cardiovascular changes
Time Frame: Screening, Wk 4, Wk 25, Wk 52/EOT
Screening, Wk 4, Wk 25, Wk 52/EOT
The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events
Time Frame: As needed
As needed
The nature, incidence, and duration of adverse events monitored throughout the study by vital signs evaluation at each visit, weight measurements and clinical laboratory monitoring periodically
Time Frame: Screening, Baseline, Wk 4, Wk 12, Wk 25, Wk 38, & Wk 52/EOT
Screening, Baseline, Wk 4, Wk 12, Wk 25, Wk 38, & Wk 52/EOT
All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound
Time Frame: Weekly
Weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
The Hamilton Rating Scale for Anxiety (HAM-A) will be used to assess symptoms of Generalized Anxiety Disorder (GAD) over a one year time period.
Time Frame: Baseline, Wk 12, Wk 25, Wk 38, Wk 51 & Wk 52/EOT
Baseline, Wk 12, Wk 25, Wk 38, Wk 51 & Wk 52/EOT
The Clinical Global Impression of Severity (CGI-S), and the Daily Diary (DD) will also be used to assess symptoms of GAD over a one year time period.
Time Frame: Baseline, Wk 51 & Wk 52/EOT
Baseline, Wk 51 & Wk 52/EOT
The Health Care Utilization Questionnaire will be utilized to assess overall Health Care over a one year time period.
Time Frame: Baseline, Wk 12, Wk 25, Wk 38 & Wk 51
Baseline, Wk 12, Wk 25, Wk 38 & Wk 51

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

November 16, 2012

Last Update Submitted That Met QC Criteria

November 9, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5361022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Generalized Anxiety Disorder

Clinical Trials on PD 0332334

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe