Ignite Creation Date:
2024-05-06 @ 2:51 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02144610
Status:
TERMINATED
Last Update Posted:
2019-08-13
First Post:
2014-05-20
Brief Title:
Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia
Sponsor:
AnGes USA Inc
Organization:
AnGes USA Inc
Study Overview
Official Title:
A Phase 3 Double-Blind Randomized Placebo-Controlled Study to Evaluate the Safety and Efficacy of AMG0001 in Subjects With Critical Limb Ischemia
Status:
TERMINATED
Status Verified Date:
2019-07
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:
AGILITY
Brief Summary:
Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia
Detailed Description:
This is a double-blind randomized placebo-controlled phase 3 multinational multicenter study of AMG0001 HGF plasmid in subjects with Critical Limb Ischemia CLI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-001129-34 | EUDRACT_NUMBER | None | None |