Study Evaluating Bifeprunox in Patients With Schizophrenia.

Phase 3TerminatedNCT00366327

Wyeth is now a wholly owned subsidiary of Pfizer400 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Schizophrenia

Interventions

BifeprunoxDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 66 Years

Medical Language ↔ Plain English

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

Locations (82)

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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Unnamed facility

Little Rock, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Anaheim, California, United States

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Anaheim, California, United States

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Boynton Beach, California, United States

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Buena Park, California, United States

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Cerritos, California, United States

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Costa Mesa, California, United States

Unnamed facility

Costa Mesa, California, United States

...and 72 more locations