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Study Evaluating Bifeprunox in Patients With Schizophrenia.

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00366327
First Posted: August 21, 2006
Last Update Posted: February 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.

Condition Intervention Phase
Schizophrenia Drug: Bifeprunox Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366327


  Show 82 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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
ClinicalTrials.gov Identifier: NCT00366327     History of Changes
Other Study ID Numbers: 3168A1-314
B3101010 ( Other Identifier: Pfizer )
First Submitted: August 17, 2006
First Posted: August 21, 2006
Last Update Posted: February 11, 2013
Last Verified: April 2008

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders