Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00366327

  Show 82 Study Locations
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

No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00366327     History of Changes
Other Study ID Numbers: 3168A1-314, B3101010
Study First Received: August 17, 2006
Last Updated: February 7, 2013
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Colombia: Institutional Review Board
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features processed this record on November 25, 2014