Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-29 @ 9:06 PM
Study NCT ID:
NCT03386851
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2017-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder
Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
Post-Marketing Surveillance of Safety and Effectiveness of Abilify Maintena® Injections in Korean Patients With Schizophrenia or Bipolar 1 Disorder Under the "New Drug Re-Examination"
Status:
COMPLETED
Status Verified Date:
2022-02
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:
This is a Post-Marketing Surveillance (PMS) of Abilify Maintena® Injections in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: Ministry of Food and Drug Safety(MFDS) Notification).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: