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OpenTrials
Completed

NCT Number: NCT00366171

Open Label Extension Study of Bifeprunox

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients who have successfully completed Wyeth study 3168A1-311-US.
  • A signed and dated informed consent form for this study.
  • No major protocol violations in previous study.

Exclusion criteria

  • Clinically important abnormalities noted in preceding short-term study that have not resolved.
  • Use of prohibited treatments in the preceding short-term study.
  • Meeting any exclusion criteria for the preceding short-term study.

Treatment and study plan

Bifeprunox

Drug

Primary outcomes

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Aug 21, 2006
Registry last updated
Dec 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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