Bifeprunox in the Treatment of Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
bifeprunox
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring open-label study in the treatment of schizophrenia
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00193687
First Posted
September 11, 2005
Last Updated
March 20, 2008
Sponsor
Solvay Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00193687
Brief Title
Bifeprunox in the Treatment of Schizophrenia
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Solvay Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia. Extension to study S154.3.001.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
open-label study in the treatment of schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
986 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bifeprunox
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Bifeprunox in the Treatment of Schizophrenia
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