Study Evaluating Bifeprunox in Patients With Schizophrenia.

Phase 3

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Bifeprunox

• Registration Number: NCT00366327
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-18
• Study First Posted: 2006-08-21
• Study Start: 2007-01
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-04
• Disposition First Submitted: 2013-02-07
• Disposition First Submitted QC: 2013-02-07
• Last Update Submitted: 2013-02-07
• Disposition First Posted: 2013-02-11
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Outpatients who have successfully completed Wyeth study 3168A1-313.
2. A signed and dated informed consent form for this study.
3. No major protocol violations in the previous study.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Bifeprunox	-

Primary Outcome Measures

Name	Time	Method
Change in weight from baseline/first dose of bifeprunox at each observation.	1 year

Secondary Outcome Measures

Name	Time	Method
Change from baseline/first dose of bifeprunox in trigyleride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impressions (CGI) score, and waist circumference at each observation.	1 year