Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257192
Status:
TERMINATED
Last Update Posted:
2021-03-25
First Post:
2005-11-21
Brief Title:
Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
Official Title:
Six Week Double-Blind Placebo Controlled Phase III Trial Evaluating The Efficacy Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Please see Detailed Description for termination reason
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 adolescents ages 13-17 with schizophrenia
Detailed Description:
Termination Reason On March 24 2009 Pfizer Inc stopped late stage Geodon pediatric clinical trials in schizophrenia A1281134 - placebo controlled A1281135 - open label As recommended by the DSMB these studies were stopped due to lack of efficacy No safety concerns were identified
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