Study Evaluating Bifeprunox in Patients With Schizophrenia.

February 7, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Bifeprunox in the Treatment of Outpatients With Schizophrenia.

An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

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
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
      • Little Rock, Arkansas, United States, 72211
    • California
      • Anaheim, California, United States, 92802
      • Anaheim, California, United States, 92804
      • Anaheim, California, United States, 92805
      • Boynton Beach, California, United States, 33426
      • Buena Park, California, United States, 90620
      • Cerritos, California, United States, 90703
      • Costa Mesa, California, United States, 92363
      • Costa Mesa, California, United States, 92627
      • Escondido, California, United States, 92025
      • Garden Grove, California, United States, 92845
      • Glendale, California, United States, 91206
      • Huntington Beach, California, United States, 92648
      • La Mesa, California, United States, 91942
      • National City, California, United States, 91950
      • Oceanside, California, United States, 92056
      • Paramount, California, United States, 90723
      • Rosemead, California, United States, 91770
      • Sacramento, California, United States, 95823
      • San Diego, California, United States, 92108
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92126
      • Santa Ana, California, United States, 92701
      • Santa Ana, California, United States, 92705
      • Torrance, California, United States, 90505
    • Connecticut
      • Farmington, Connecticut, United States, 06030
      • Hartford, Connecticut, United States, 06106
      • New London, Connecticut, United States, 06320
    • Florida
      • Ft. Lauderdale, Florida, United States, 33319
      • Hialeah, Florida, United States, 33016
      • Jacksonville, Florida, United States, 32256
      • Jacksonville, Florida, United States, 32207
      • North Miami, Florida, United States, 33161
      • Orange City, Florida, United States, 32763
      • St. Petersburg, Florida, United States, 33711
      • Tampa, Florida, United States, 33613
    • Georgia
      • Atlanta, Georgia, United States, 30307
      • Atlanta, Georgia, United States, 30308
      • Marietta, Georgia, United States, 30060
    • Idaho
      • Coevr d'Alene, Idaho, United States, 83814
    • Illinois
      • Chicago, Illinois, United States, 60631
      • Hoffman Estates, Illinois, United States, 60194
      • Joliet, Illinois, United States, 60077
      • Naperville, Illinois, United States, 60540
    • Indiana
      • Indiannapolis, Indiana, United States, 46202
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
      • Towson, Maryland, United States, 21286
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
      • Worcester, Massachusetts, United States, 01605
    • Mississippi
      • Flowood, Mississippi, United States, 39232
    • Missouri
      • St. Louis, Missouri, United States, 63104
      • St. Louis, Missouri, United States, 63110
      • St. Louis, Missouri, United States, 63118
      • St. Louis, Missouri, United States, 63128
    • Nebraska
      • North Platte, Nebraska, United States, 69101
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
      • Clementon, New Jersey, United States, 08021
    • New York
      • Brooklyn, New York, United States, 11203
      • Buffalo, New York, United States, 14215
      • Rochester, New York, United States, 14624
      • Staten Island, New York, United States, 10312
    • North Carolina
      • Butner, North Carolina, United States, 27509
      • Morehead City, North Carolina, United States, 28557
    • Ohio
      • Beachwood, Ohio, United States, 44122
      • Cleveland, Ohio, United States, 44109
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73139
    • Pennsylvania
      • East Stroudsburg, Pennsylvania, United States, 18301
      • Jenkintown, Pennsylvania, United States, 19046
      • Norristown, Pennsylvania, United States, 19401
      • Philadelphia, Pennsylvania, United States, 19149
      • Pittsburgh, Pennsylvania, United States, 15108
    • Tennessee
      • Cordova, Tennessee, United States, 38018
      • Memphis, Tennessee, United States, 38105
      • Memphis, Tennessee, United States, 38157
    • Texas
      • Austin, Texas, United States, 78756
      • DeSoto, Texas, United States, 75115
      • Houston, Texas, United States, 77007
      • Irving, Texas, United States, 75062
      • San Antonio, Texas, United States, 78229
    • Washington
      • Kirkland, Washington, United States, 98033

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 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Outpatients who have successfully completed Wyeth study 3168A1-313.
  2. A signed and dated informed consent form for this study.
  3. No major protocol violations in the previous study.

Exclusion Criteria:

  1. Clinically important abnormalities in the preceding short-term study that have not resolved.
  2. Use of prohibited treatments in the preceding short-term study.
  3. Meeting any exclusion criteria in the preceding short-term study

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Bifeprunox
Flex dose (20 or 30 mg)tablet, QD for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in weight from baseline/first dose of bifeprunox at each observation.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline/first dose of bifeprunox in trigyleride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impressions (CGI) score, and waist circumference at each observation.
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

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

January 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria

August 18, 2006

First Posted (Estimate)

August 21, 2006

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3168A1-314
  • B3101010 (Other Identifier: Pfizer)

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.

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