Open Label Extension Study of Bifeprunox

Phase 3CompletedNCT00366171

Wyeth is now a wholly owned subsidiary of Pfizer120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Schizophrenia

Interventions

BifeprunoxDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 66 Years

Medical Language ↔ Plain English

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.

Locations (83)

Outcomes

Primary Outcomes

Change in body weight from baseline/first dose of bifeprunox at each observation.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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Unnamed facility

Little Rock, Arkansas, United States

Unnamed facility

Little Rock, Arkansas, United States

Unnamed facility

Anaheim, California, United States

Unnamed facility

Anaheim, California, United States

Unnamed facility

Anaheim, California, United States

Unnamed facility

Boynton Beach, California, United States

Unnamed facility

Buena Park, California, United States

Unnamed facility

Cerritos, California, United States

Unnamed facility

Costa Mesa, California, United States

Unnamed facility

Costa Mesa, California, United States

...and 73 more locations