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Bifeprunox in the Treatment of Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00193713
First Posted: September 19, 2005
Last Update Posted: January 16, 2015
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:
Solvay Pharmaceuticals
September 11, 2005
September 19, 2005
January 16, 2015
May 2005
November 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00193713 on ClinicalTrials.gov Archive Site
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Bifeprunox in the Treatment of Schizophrenia
A Randomized, Double-Blind, Olanzapine-Referenced, Parallel-Group Safety and Efficacy Study of Flexible Doses of Bifeprunox in the Long-term Treatment of Schizpohrenia (Extension of S1543003)
Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Schizophrenia
Drug: bifeprunox
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2006
November 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of schizophrenia
  • understand nature of study
  • able to be managed in out-patient setting for long-term bifeprunox treatment

Exclusion Criteria:

  • current primary diagnosis other than schizophrenia
  • suicide risk
  • diagnosis or history of substance abuse
  • uncontrolled hypertension
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00193713
S154.3.004
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Solvay Pharmaceuticals
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
January 2007

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