Trials / Terminated
TerminatedNCT02144610
Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- AnGes USA, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 90 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HGF Plasmid (AMG0001) | IM |
| BIOLOGICAL | Matching Placebo | IM |
Timeline
- Start date
- 2014-11-12
- Primary completion
- 2016-11-28
- Completion
- 2016-11-28
- First posted
- 2014-05-22
- Last updated
- 2019-08-13
- Results posted
- 2019-08-13
Locations
60 sites across 11 countries: United States, Belgium, Canada, Denmark, Finland, France, Hungary, Italy, Netherlands, Poland, Sweden
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02144610. Inclusion in this directory is not an endorsement.