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Study Evaluating Bifeprunox in Patients With Schizophrenia.

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Little Rock, Arkansas, 72201 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-66 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00366327
Pfizer
Terminated
Study Evaluating Bifeprunox in Patients With Schizophrenia.

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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.
An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Schizophrenia
Drug: Bifeprunox
Flex dose (20 or 30 mg)tablet, QD for 1 year
Experimental: A
Intervention: Drug: Bifeprunox
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
400
March 2008
March 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 66 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00366327
3168A1-314
B3101010 ( Other Identifier: Pfizer )
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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