Open Label Extension Study of Bifeprunox

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

A one year extension study using flexible doses, 20 or 30 mg daily, of open-label bifeprunox.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Bifeprunox

• Study Type: Interventional
• Enrollment: 120
• Phase: Phase 3

Contacts and Locations

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
    • Durham, North Carolina, United States, 27707
    • 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, 19406
    • 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

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 3168A1-311-US.
2. A signed and dated informed consent form for this study.
3. No major protocol violations in previous study.

Exclusion Criteria:

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

Study Plan

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
Change in body weight from baseline/first dose of bifeprunox at each observation.

Secondary Outcome Measures

Outcome Measure
Change from baseline/first dose of bifeprunox for triglyceride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impression (CGI)-Score, and waist circumference at each observation.

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion: December 7, 2022
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: August 17, 2006
• First Submitted That Met QC Criteria: August 17, 2006
• First Posted (Estimate): August 21, 2006

Study Record Updates

• Last Update Posted (Estimate): December 27, 2007
• Last Update Submitted That Met QC Criteria: December 18, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 3168A1-312

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No