Study Evaluating Bifeprunox in Patients With Schizophrenia.

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00366327

First received: August 17, 2006

Last updated: February 7, 2013

Last verified: April 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

August 17, 2006

Last Updated Date

February 7, 2013

Start Date ^ICMJE

January 2007

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in weight from baseline/first dose of bifeprunox at each observation. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00366327 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Bifeprunox in Patients With Schizophrenia.

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Bifeprunox

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

Study Arm (s)

Experimental: A

Intervention: Drug: Bifeprunox

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

400

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Outpatients who have successfully completed Wyeth study 3168A1-313.
A signed and dated informed consent form for this study.
No major protocol violations in the previous study.

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 66 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00366327

Other Study ID Numbers ^ICMJE

3168A1-314, B3101010

Has Data Monitoring Committee

Responsible Party

Wyeth is now a wholly owned subsidiary of Pfizer

Study Sponsor ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

Information Provided By

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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