Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-28 @ 5:08 AM
Study NCT ID:
NCT01065766
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2010-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of JANUMET in Usual Practice
Status:
COMPLETED
Status Verified Date:
2015-02
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:
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010_006 | OTHER | Merck | View |