Open Label Extension Study of Bifeprunox

NCT ID: NCT00366171

Last Updated: 2007-12-27

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-10-31

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bifeprunox

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Little Rock, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Anaheim, California, United States

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Anaheim, California, United States

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Boynton Beach, California, United States

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Buena Park, California, United States

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Cerritos, California, United States

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Costa Mesa, California, United States

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Costa Mesa, California, United States

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Escondido, California, United States

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Garden Grove, California, United States

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Glendale, California, United States

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Huntington Beach, California, United States

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La Mesa, California, United States

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National City, California, United States

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Oceanside, California, United States

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Paramount, California, United States

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Rosemead, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Santa Ana, California, United States

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Torrance, California, United States

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Farmington, Connecticut, United States

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Hartford, Connecticut, United States

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New London, Connecticut, United States

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Fort Lauderdale, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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North Miami, Florida, United States

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Orange City, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Coevr d'Alene, Idaho, United States

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Chicago, Illinois, United States

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Hoffman Estates, Illinois, United States

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Joliet, Illinois, United States

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Naperville, Illinois, United States

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Indiannapolis, Indiana, United States

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Lake Charles, Louisiana, United States

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Gaithersburg, Maryland, United States

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Towson, Maryland, United States

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Pittsfield, Massachusetts, United States

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Worcester, Massachusetts, United States

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Flowood, Mississippi, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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North Platte, Nebraska, United States

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Cherry Hill, New Jersey, United States

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Clementon, New Jersey, United States

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Brooklyn, New York, United States

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Buffalo, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Butner, North Carolina, United States

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Durham, North Carolina, United States

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Morehead City, North Carolina, United States

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Beachwood, Ohio, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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East Stroudsburg, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Cordova, Tennessee, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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DeSoto, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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San Antonio, Texas, United States

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Kirkland, Washington, United States

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Countries

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United States

Other Identifiers

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3168A1-312

Identifier Type: -

Identifier Source: org_study_id