Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-26 @ 6:58 AM
Study NCT ID:
NCT02248168
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2014-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Mirapex PMS Study Final Report
Status:
COMPLETED
Status Verified Date:
2014-09
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 objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval.
* Unexpected adverse events (especially, serious adverse events (SAEs))
* To find out the status of incidence of adverse events under actual practice
* Factors on the safety profile
* Factors on the efficacy profile
* Unexpected adverse events (especially, serious adverse events (SAEs))
* To find out the status of incidence of adverse events under actual practice
* Factors on the safety profile
* Factors on the efficacy profile
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: