Study Evaluating Bifeprunox in Patients With Schizophrenia.
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Bifeprunox in the Treatment of Outpatients With Schizophrenia.
2 other identifiers
interventional
400
1 country
82
Brief Summary
An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Jan 2007
Shorter than P25 for phase_3 schizophrenia
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2006
CompletedFirst Posted
Study publicly available on registry
August 21, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFebruary 11, 2013
April 1, 2008
1.2 years
August 17, 2006
February 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in weight from baseline/first dose of bifeprunox at each observation.
1 year
Secondary Outcomes (1)
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.
1 year
Study Arms (1)
A
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Outpatients who have successfully completed Wyeth study 3168A1-313.
- A signed and dated informed consent form for this study.
- No major protocol violations in the previous study.
You may not qualify if:
- Clinically important abnormalities in the preceding short-term study that have not resolved.
- Use of prohibited treatments in the preceding short-term study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
Unknown Facility
Little Rock, Arkansas, 72201, United States
Unknown Facility
Little Rock, Arkansas, 72211, United States
Unknown Facility
Anaheim, California, 92802, United States
Unknown Facility
Anaheim, California, 92804, United States
Unknown Facility
Anaheim, California, 92805, United States
Unknown Facility
Boynton Beach, California, 33426, United States
Unknown Facility
Buena Park, California, 90620, United States
Unknown Facility
Cerritos, California, 90703, United States
Unknown Facility
Costa Mesa, California, 92363, United States
Unknown Facility
Costa Mesa, California, 92627, United States
Unknown Facility
Escondido, California, 92025, United States
Unknown Facility
Garden Grove, California, 92845, United States
Unknown Facility
Glendale, California, 91206, United States
Unknown Facility
Huntington Beach, California, 92648, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
National City, California, 91950, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
Paramount, California, 90723, United States
Unknown Facility
Rosemead, California, 91770, United States
Unknown Facility
Sacramento, California, 95823, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
San Diego, California, 92126, United States
Unknown Facility
Santa Ana, California, 92701, United States
Unknown Facility
Santa Ana, California, 92705, United States
Unknown Facility
Torrance, California, 90505, United States
Unknown Facility
Farmington, Connecticut, 06030, United States
Unknown Facility
Hartford, Connecticut, 06106, United States
Unknown Facility
New London, Connecticut, 06320, United States
Unknown Facility
Fort Lauderdale, Florida, 33319, United States
Unknown Facility
Hialeah, Florida, 33016, United States
Unknown Facility
Jacksonville, Florida, 32207, United States
Unknown Facility
Jacksonville, Florida, 32256, United States
Unknown Facility
North Miami, Florida, 33161, United States
Unknown Facility
Orange City, Florida, 32763, United States
Unknown Facility
St. Petersburg, Florida, 33711, United States
Unknown Facility
Tampa, Florida, 33613, United States
Unknown Facility
Atlanta, Georgia, 30307, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Unknown Facility
Coevr d'Alene, Idaho, 83814, United States
Unknown Facility
Chicago, Illinois, 60631, United States
Unknown Facility
Hoffman Estates, Illinois, 60194, United States
Unknown Facility
Joliet, Illinois, 60077, United States
Unknown Facility
Naperville, Illinois, 60540, United States
Unknown Facility
Indiannapolis, Indiana, 46202, United States
Unknown Facility
Lake Charles, Louisiana, 70601, United States
Unknown Facility
Gaithersburg, Maryland, 20877, United States
Unknown Facility
Towson, Maryland, 21286, United States
Unknown Facility
Pittsfield, Massachusetts, 01201, United States
Unknown Facility
Worcester, Massachusetts, 01605, United States
Unknown Facility
Flowood, Mississippi, 39232, United States
Unknown Facility
St Louis, Missouri, 63104, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
St Louis, Missouri, 63118, United States
Unknown Facility
St Louis, Missouri, 63128, United States
Unknown Facility
North Platte, Nebraska, 69101, United States
Unknown Facility
Cherry Hill, New Jersey, 08002, United States
Unknown Facility
Clementon, New Jersey, 08021, United States
Unknown Facility
Brooklyn, New York, 11203, United States
Unknown Facility
Buffalo, New York, 14215, United States
Unknown Facility
Rochester, New York, 14624, United States
Unknown Facility
Staten Island, New York, 10312, United States
Unknown Facility
Butner, North Carolina, 27509, United States
Unknown Facility
Morehead City, North Carolina, 28557, United States
Unknown Facility
Beachwood, Ohio, 44122, United States
Unknown Facility
Cleveland, Ohio, 44109, United States
Unknown Facility
Oklahoma City, Oklahoma, 73139, United States
Unknown Facility
East Stroudsburg, Pennsylvania, 18301, United States
Unknown Facility
Jenkintown, Pennsylvania, 19046, United States
Unknown Facility
Norristown, Pennsylvania, 19401, United States
Unknown Facility
Philadelphia, Pennsylvania, 19149, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15108, United States
Unknown Facility
Cordova, Tennessee, 38018, United States
Unknown Facility
Memphis, Tennessee, 38105, United States
Unknown Facility
Memphis, Tennessee, 38157, United States
Unknown Facility
Austin, Texas, 78756, United States
Unknown Facility
DeSoto, Texas, 75115, United States
Unknown Facility
Houston, Texas, 77007, United States
Unknown Facility
Irving, Texas, 75062, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Kirkland, Washington, 98033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2006
First Posted
August 21, 2006
Study Start
January 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
February 11, 2013
Record last verified: 2008-04