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Trial record 1 of 1 for:    NCT00366327
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Study Evaluating Bifeprunox in Patients With Schizophrenia.

This study has been terminated.
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: August 17, 2006
Last updated: February 7, 2013
Last verified: April 2008
An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.

Condition Intervention Phase
Drug: Bifeprunox
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Bifeprunox in the Treatment of Outpatients With Schizophrenia.

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Change in weight from baseline/first dose of bifeprunox at each observation. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1 year ]

Estimated Enrollment: 400
Study Start Date: January 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Bifeprunox
Flex dose (20 or 30 mg)tablet, QD for 1 year


Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00366327

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Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00366327     History of Changes
Other Study ID Numbers: 3168A1-314
B3101010 ( Other Identifier: Pfizer )
Study First Received: August 17, 2006
Last Updated: February 7, 2013

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders processed this record on May 25, 2017