Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380224
Status:
COMPLETED
Last Update Posted:
2007-12-27
First Post:
2006-09-21
Brief Title:
Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Parallel-Group Fixed-Dose Study of the Effect on Weight of Befeprunox Versus Olanzapine in the Treatment of Outpatients With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare bifeprunox to a currently marketed medication Zyprexa olanzapine with respect to the affect on weight during the treatment of outpatients with schizophrenia The study will compare the effect of these medications on several variables including body weight and triglyceride levels
Detailed Description:
This is a multicenter randomized double-blind parallel-group study of bifeprunox in the treatment of outpatients with schizophrenia with olanzapine as the active comparator Subjects must be stable for 3 months or more of treatment with olanzapine at baseline There will be 2 treatment arms in this study approximately 60 subjects per arm After randomization and blinding each subject will either remain on olanzapine or switch to bifeprunox Assessments including body weight and waist measurements will be made at each study visitSubjects will participate in the study for approximately 11 weeks After a screening period of 6 to 14 days eligible subjects will be treated for 8 weeks Subjects who do not enter the long-term extension will return for a follow-up visit 7 days after discontinuing the use of test article Subjects who do enter the long-term extension will have a 7-day tapertitration period after the 8 weeks of double-blind treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None