Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-31 @ 11:50 AM
Study NCT ID:
NCT01782833
Status:
COMPLETED
Last Update Posted:
2019-03-01
First Post:
2013-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pletaal SR Post Marketing Observational Study
Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Prospective, Post Marketing Observational Study to Evaluate the Safety of Pletaal® SR Capsule
Status:
COMPLETED
Status Verified Date:
2019-02
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:
PLTSRPMOS
Brief Summary:
This is a Post Marketing Observational Study of cilostazol (Pletaal® SR capsule). As this study is observational in nature to collect the safety data after administrating the Pletaal SR capsule, from baseline to 16 weeks.
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:
False
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?: