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Bifeprunox in the Treatment of Schizophrenia

This study has been completed.
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: September 11, 2005
Last updated: March 20, 2008
Last verified: March 2008
Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia. Extension to study S154.3.001.

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, Flexible-Dose, Long-Term Safety and Efficacy Study of Bifeprunox in the Treatment of Schizpohrenia (Extension of S154.3.001)

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

Enrollment: 986
Study Start Date: September 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00193687

Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information Identifier: NCT00193687     History of Changes
Other Study ID Numbers: S154.3.002
Study First Received: September 11, 2005
Last Updated: March 20, 2008

Keywords provided by Solvay Pharmaceuticals:
open-label study in the treatment of schizophrenia

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders processed this record on August 22, 2017