Study Evaluating Bifeprunox in Patients With Schizophrenia.

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00366327
• Other study ID #: 3168A1-314
• Secondary ID: B3101010
• Status: Terminated
• Phase: Phase 3
• First received: August 17, 2006
• Last updated: February 7, 2013
• Start date: January 2007
• Est. completion date: March 2008

Study information

• Verified date: April 2008
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosColombia: Institutional Review BoardPeru: General Directorate of Pharmaceuticals, Devices, and DrugsUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 66 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Bifeprunox
Flex dose (20 or 30 mg)tablet, QD for 1 year

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight from baseline/first dose of bifeprunox at each observation.		1 year	Yes
Secondary	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.		1 year	No