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Sponsors and Collaborators: |
H. Lundbeck A/S Solvay Pharmaceuticals |
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Information provided by: | H. Lundbeck A/S |
ClinicalTrials.gov Identifier: | NCT00861497 |
The purpose of this study is to provide access to bifeprunox for patients, who have completed previous studies with bifeprunox, and require continued treatment with bifeprunox, other treatment not being adequate. A further purpose is to investigate the safety and side-effects of bifeprunox during long-term treatment.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: Bifeprunox |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | An Open-Label Safety Study of Bifeprunox Investigating Flexible Doses of 20, 30, or 40mg/Day in Patients With Schizophrenia Who Have Completed Studies 10206 or 10265 |
Enrollment: | 11 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | June 2009 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Bifeprunox
Flexible dosage: 20, 30, or 40 mg/day
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This is a non-controlled, open-label, flexible-dose, international multi-centre extension study. The patient population consists of male and female patients with schizophrenia, who have completed open-label bifeprunox studies 10206 or 10265, and require continued treatment with bifeprunox, other treatments not being feasible as judged by the investigator.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | H. Lundbeck A/S ( H. Lundbeck A/S ) |
Study ID Numbers: | 11051, EudraCT 2005-000497-50 |
Study First Received: | March 12, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00861497 History of Changes |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Open-label Flexible-dose Extension Safety study |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features |