Bifeprunox in the Treatment of Schizophrenia

This study has been completed.
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: September 11, 2005
Last updated: January 15, 2015
Last verified: January 2007

Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia.

Condition Intervention Phase
Drug: bifeprunox
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: May 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT00193713

Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided Identifier: NCT00193713     History of Changes
Other Study ID Numbers: S154.3.004
Study First Received: September 11, 2005
Last Updated: January 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
double-blind study in the treatment of schizophrenia

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features processed this record on October 09, 2015