Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01944618
Status:
TERMINATED
Last Update Posted:
2016-09-13
First Post:
2013-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP)
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
forREAL: FORXIGA (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) PRESCRIPTION EVENT MONITORING PROGRAM
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Participant Data obtained to 30Sep2015:
Baseline data: 447 6 month data: 253 Program terminated: recruitment target not met. No analysis will be provided.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
forREAL
Brief Summary:
The study purpose is to assess adverse events in patients with Type 2 diabetes who have newly been prescribed Forxiga for the management of glycemic control
Detailed Description:
Observational Model: Other: A post-marketing evaluation of the safety of Forxiga through an observational prescription adverse event monitoring program (registry-based monitoring program) is warranted to assess real-world incidence of adverse events in routine clinical practice
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?: