Open Label Extension Study of Bifeprunox

Phase 3

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00366171
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

A one year extension study using flexible doses, 20 or 30 mg daily, of open-label bifeprunox.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-17
• Study First Posted: 2006-08-21
• Study Start: 2006-11
• Study Completion: 2007-10
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-18
• Last Update Posted: 2007-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Outpatients who have successfully completed Wyeth study 3168A1-311-US.
2. A signed and dated informed consent form for this study.
3. No major protocol violations in previous study.

Exclusion Criteria

1. Clinically important abnormalities noted in preceding short-term study that have not resolved.
2. Use of prohibited treatments in the preceding short-term study.
3. Meeting any exclusion criteria for the preceding short-term study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in body weight from baseline/first dose of bifeprunox at each observation.

Secondary Outcome Measures

Name	Time	Method
Change from baseline/first dose of bifeprunox for triglyceride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impression (CGI)-Score, and waist circumference at each observation.