Study Evaluating Bifeprunox in Patients With Schizophrenia.

NCT00366327

Last updated date
Study Location
Little Rock, Arkansas, 72201, United States
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Bifeprunox in Patients With Schizophrenia.
Official Title  ICMJE An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Bifeprunox in the Treatment of Outpatients With Schizophrenia.
Brief Summary An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: Bifeprunox
Flex dose (20 or 30 mg)tablet, QD for 1 year
Study Arms  ICMJE Experimental: A
Intervention: Drug: Bifeprunox
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: August 18, 2006)
400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 66 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00366327
Other Study ID Numbers  ICMJE 3168A1-314
B3101010 ( Other Identifier: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP