Bifeprunox in the Treatment of Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00193713
First received: September 11, 2005
Last updated: January 18, 2007
Last verified: January 2007
  Purpose

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


Condition Intervention Phase
Schizophrenia
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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193713

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

No publications provided

ClinicalTrials.gov Identifier: NCT00193713     History of Changes
Other Study ID Numbers: S154.3.004
Study First Received: September 11, 2005
Last Updated: January 18, 2007
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:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014