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Bifeprunox in the Treatment of Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00193687
First Posted: September 19, 2005
Last Update Posted: March 24, 2008
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
  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
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)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193687


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

ClinicalTrials.gov Identifier: NCT00193687     History of Changes
Other Study ID Numbers: S154.3.002
First Submitted: September 11, 2005
First Posted: September 19, 2005
Last Update Posted: March 24, 2008
Last Verified: March 2008

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders