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Bifeprunox in the Treatment of Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00193687
First received: September 11, 2005
Last updated: March 20, 2008
Last verified: March 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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)
  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: NCT00193687

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

No publications provided

ClinicalTrials.gov Identifier: NCT00193687     History of Changes
Other Study ID Numbers: S154.3.002
Study First Received: September 11, 2005
Last Updated: March 20, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
open-label 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 May 23, 2013