Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257166
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2005-11-21
Brief Title:
Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder Manic or Mixed
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
Official Title:
Four Week Double-Blind Placebo Controlled Phase III Trial Evaluating The Efficacy Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder Manic Or Mixed
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents ages 10-17 with bipolar I disorder manic or mixed
Detailed Description:
None
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