Ignite Creation Date:
2024-05-05 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 9:43 AM
Study NCT ID:
NCT00604214
Status:
COMPLETED
Last Update Posted:
2012-09-18
First Post:
2008-01-24
Brief Title:
Efficacy and Safety of Drotrecogin Alfa Activated in Adult Patients With Septic Shock
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multicenter Phase 3 Study of Drotrecogin Alfa Activated Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock
Status:
COMPLETED
Status Verified Date:
2012-08
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 this placebo-controlled study is to determine if drotrecogin alfa activated treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock This study will also assess the effectiveness of drotrecogin alfa activated in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| F1K-MC-EVDP | OTHER | Eli Lilly and Company | None |