Clinical trial NCT00366327: Study Evaluating Bifeprunox in Patients With Schizophrenia.
Official title: An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Bifeprunox in the Treatment of Outpatients With Schizophrenia.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in weight from baseline/first dose of bifeprunox at each observation.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Anaheim
country: United States
state: California
city: Anaheim
country: United States
state: California
city: Boynton Beach
country: United States
state: California
city: Buena Park
country: United States
state: California
city: Cerritos
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Escondido
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Glendale
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: La Mesa
country: United States
state: California
city: National City
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Paramount
country: United States
state: California
city: Rosemead
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: Hartford
country: United States
state: Connecticut
city: New London
country: United States
state: Connecticut
city: Ft. Lauderdale
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Orange City
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Coevr d'Alene
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Hoffman Estates
country: United States
state: Illinois
city: Joliet
country: United States
state: Illinois
city: Naperville
country: United States
state: Illinois
city: Indiannapolis
country: United States
state: Indiana
city: Lake Charles
country: United States
state: Louisiana
city: Gaithersburg
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Pittsfield
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Flowood
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: North Platte
country: United States
state: Nebraska
city: Cherry Hill
country: United States
state: New Jersey
city: Clementon
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Butner
country: United States
state: North Carolina
city: Morehead City
country: United States
state: North Carolina
city: Beachwood
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: East Stroudsburg
country: United States
state: Pennsylvania
city: Jenkintown
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Cordova
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: DeSoto
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Kirkland
country: United States
state: Washington
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: