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Open Label Extension Study of Bifeprunox
This study has been completed.
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00366171
  Purpose

A one year extension study using flexible doses, 20 or 30 mg daily, of open-label bifeprunox.


Condition Intervention Phase
Schizophrenia
 Drug: Bifeprunox
 Phase III

MedlinePlus related topics: Schizophrenia
Drug Information available for: Bifeprunox Bifeprunox mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Bifeprunox in the Treatment of Outpatients With Schizophrenia.

Further study details as provided by Wyeth:

Primary Outcome Measures:
  • Change in body weight from baseline/first dose of bifeprunox at each observation.

Secondary Outcome Measures:
  • Change from baseline/first dose of bifeprunox for triglyceride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impression (CGI)-Score, and waist circumference at each observation.

Estimated Enrollment: 120
Study Start Date: November 2006
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatients who have successfully completed Wyeth study 3168A1-311-US.
  2. A signed and dated informed consent form for this study.
  3. No major protocol violations in previous study.

Exclusion Criteria:

  1. Clinically important abnormalities noted in preceding short-term study that have not resolved.
  2. Use of prohibited treatments in the preceding short-term study.
  3. Meeting any exclusion criteria for the preceding short-term study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366171

  Show 85 Study Locations
Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
  More Information

Study ID Numbers: 3168A1-312
Study First Received: August 17, 2006
Last Updated: December 18, 2007
ClinicalTrials.gov Identifier: NCT00366171  
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth:
Schizophrenia

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009



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