Open Label Extension Study of Bifeprunox

Wyeth

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Bifeprunox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00366171

3168A1-312

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 66 years old

Volunteers: No 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 exclusion criteria for the preceding short-term study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)