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

NCT ID: NCT00735267

Last Updated: 2012-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Generalized Anxiety Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Generalized Anxiety Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PD 0332334

Dosage Form: 25 or 100 mg oral capsules Dosage and frequency: 350-600 mg twice a day Duration: 1 year

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

imagabalin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Litchfield Park, Arizona, United States

Site Status

Pfizer Investigational Site

Arcadia, California, United States

Site Status

Pfizer Investigational Site

Beverly Hills, California, United States

Site Status

Pfizer Investigational Site

Costa Mesa, California, United States

Site Status

Pfizer Investigational Site

Costa Mesa, California, United States

Site Status

Pfizer Investigational Site

Encino, California, United States

Site Status

Pfizer Investigational Site

Escondido, California, United States

Site Status

Pfizer Investigational Site

Murrieta, California, United States

Site Status

Pfizer Investigational Site

National City, California, United States

Site Status

Pfizer Investigational Site

Newport Beach, California, United States

Site Status

Pfizer Investigational Site

Orange, California, United States

Site Status

Pfizer Investigational Site

Pasadena, California, United States

Site Status

Pfizer Investigational Site

Redlands, California, United States

Site Status

Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

Sherman Oaks, California, United States

Site Status

Pfizer Investigational Site

Temecula, California, United States

Site Status

Pfizer Investigational Site

Upland, California, United States

Site Status

Pfizer Investigational Site

Wildomar, California, United States

Site Status

Pfizer Investigational Site

Denver, Colorado, United States

Site Status

Pfizer Investigational Site

Hamden, Connecticut, United States

Site Status

Pfizer Investigational Site

Norwich, Connecticut, United States

Site Status

Pfizer Investigational Site

Altamonte Springs, Florida, United States

Site Status

Pfizer Investigational Site

Fort Myers, Florida, United States

Site Status

Pfizer Investigational Site

Jacksonville, Florida, United States

Site Status

Pfizer Investigational Site

Maitland, Florida, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Orange City, Florida, United States

Site Status

Pfizer Investigational Site

Orlando, Florida, United States

Site Status

Pfizer Investigational Site

South Miami, Florida, United States

Site Status

Pfizer Investigational Site

West Palm Beach, Florida, United States

Site Status

Pfizer Investigational Site

Atlanta, Georgia, United States

Site Status

Pfizer Investigational Site

Atlanta, Georgia, United States

Site Status

Pfizer Investigational Site

Marietta, Georgia, United States

Site Status

Pfizer Investigational Site

Libertyville, Illinois, United States

Site Status

Pfizer Investigational Site

Naperville, Illinois, United States

Site Status

Pfizer Investigational Site

Park Ridge, Illinois, United States

Site Status

Pfizer Investigational Site

Greenwood, Indiana, United States

Site Status

Pfizer Investigational Site

Terre Haute, Indiana, United States

Site Status

Pfizer Investigational Site

Overland Park, Kansas, United States

Site Status

Pfizer Investigational Site

Prairie Village, Kansas, United States

Site Status

Pfizer Investigational Site

Wichita, Kansas, United States

Site Status

Pfizer Investigational Site

Owensboro, Kentucky, United States

Site Status

Pfizer Investigational Site

Lake Charles, Louisiana, United States

Site Status

Pfizer Investigational Site

Baltimore, Maryland, United States

Site Status

Pfizer Investigational Site

Belmont, Massachusetts, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Fall River, Massachusetts, United States

Site Status

Pfizer Investigational Site

Haverhill, Massachusetts, United States

Site Status

Pfizer Investigational Site

Pittsfield, Massachusetts, United States

Site Status

Pfizer Investigational Site

Omaha, Nebraska, United States

Site Status

Pfizer Investigational Site

Las Vegas, Nevada, United States

Site Status

Pfizer Investigational Site

Nashua, New Hampshire, United States

Site Status

Pfizer Investigational Site

Albuquerque, New Mexico, United States

Site Status

Pfizer Investigational Site

Brooklyn, New York, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

Rochester, New York, United States

Site Status

Pfizer Investigational Site

The Bronx, New York, United States

Site Status

Pfizer Investigational Site

Raleigh, North Carolina, United States

Site Status

Pfizer Investigational Site

Columbus, Ohio, United States

Site Status

Pfizer Investigational Site

Dayton, Ohio, United States

Site Status

Pfizer Investigational Site

Toledo, Ohio, United States

Site Status

Pfizer Investigational Site

Toledo, Ohio, United States

Site Status

Pfizer Investigational Site

Bethany, Oklahoma, United States

Site Status

Pfizer Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Pfizer Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Pfizer Investigational Site

Portland, Oregon, United States

Site Status

Pfizer Investigational Site

Salem, Oregon, United States

Site Status

Pfizer Investigational Site

Allentown, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Media, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Norristown, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Lincoln, Rhode Island, United States

Site Status

Pfizer Investigational Site

Columbia, South Carolina, United States

Site Status

Pfizer Investigational Site

Memphis, Tennessee, United States

Site Status

Pfizer Investigational Site

Memphis, Tennessee, United States

Site Status

Pfizer Investigational Site

Austin, Texas, United States

Site Status

Pfizer Investigational Site

Dallas, Texas, United States

Site Status

Pfizer Investigational Site

Dallas, Texas, United States

Site Status

Pfizer Investigational Site

DeSoto, Texas, United States

Site Status

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Pfizer Investigational Site

Lake Jackson, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

Woodstock, Vermont, United States

Site Status

Pfizer Investigational Site

Charlottesville, Virginia, United States

Site Status

Pfizer Investigational Site

Seattle, Washington, United States

Site Status

Pfizer Investigational Site

Middleton, Wisconsin, United States

Site Status

Pfizer Investigational Site

Waukesha, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A5361022

Identifier Type: -

Identifier Source: org_study_id