Study Evaluating Bifeprunox in Patients With Schizophrenia.

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Bifeprunox in the Treatment of Outpatients With Schizophrenia.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00366327

Enrollment

400

Registered

2006-08-21

Start date

2007-01-31

Completion date

2008-03-31

Last updated

2013-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia

Brief summary

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

Interventions

DRUGBifeprunox

Flex dose (20 or 30 mg)tablet, QD for 1 year

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 66 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026