Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-26 @ 8:11 PM
Study NCT ID:
NCT01795105
Status:
COMPLETED
Last Update Posted:
2019-04-01
First Post:
2013-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ABF Tourette's Disorder Post Marketing Surveillance Study
Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
Post-Marketing Surveillance of Safety and Efficacy of Abilify® Tablets in Korean Patients With Tourette's Disorder Under the "New Drug Re-Examination"
Status:
COMPLETED
Status Verified Date:
2018-01
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 study of Abilify® tablets in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA Notification No. 2010-94 dated 27 December 2010).
Detailed Description:
This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.
Study Oversight
Has Oversight DMC:
True
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?: