Study Evaluating Bifeprunox in Patients With Schizophrenia.

Wyeth

Status and phase: Terminated; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Bifeprunox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00366327

B3101010 (Other Identifier)

3168A1-314

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No 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 exclusion criteria in the preceding short-term study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

A

Experimental group

Treatment:

Drug: Bifeprunox