Open Label Extension Study of Bifeprunox

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00366171

Enrollment

120

Registered

2006-08-21

Start date

2006-11-30

Completion date

2007-10-31

Last updated

2007-12-27

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

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

Interventions

DRUGBifeprunox

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 3168A1-311-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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

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