NCT00861497

Bifeprunox Extension to Extension Study in Patients With Schizophrenia

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Bifeprunox	Flexible dosage: 20, 30, or 40 mg/day

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-01-01
• Completion: 2009-07-01
• First posted: 2009-03-13
• Last updated: 2013-09-16

Locations

1 site across 1 country: Italy