Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-02-12 @ 9:26 PM
Study NCT ID:
NCT02200666
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2014-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Forxiga Tablets Specific Clinical Experience Investigation for Long-term Use
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Forxiga Tablets Specific Clinical Experience Investigation for Long-term Use
Status:
COMPLETED
Status Verified Date:
2020-02
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:
The purpose of the investigation is to confirm the following under the post-marketing actual use of Forxiga Tablets (hereinafter referred to as Forxiga)
* Development of ADRs specified as Key Investigation Items and the risk factors
* Contributing factors possibly having an impact on the safety and efficacy
* Development of ADRs unexpected from the Precautions for use and ADRs under actual drug use
* Development of ADRs specified as Key Investigation Items and the risk factors
* Contributing factors possibly having an impact on the safety and efficacy
* Development of ADRs unexpected from the Precautions for use and ADRs under actual drug use
Detailed Description:
None
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?: