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NCT00604214 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,696
- Enrollment target
NCT00604214: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT00604214 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,696 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (120% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00604214, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,696 participants
- Enrollment target
Study 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.
Primary Outcome
Expressed as percentage of participants who died from any cause at Day 28 endpoint.
Interventions
- DRUG Placebo
- DRUG Drotrecogin alfa (activated)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,696 participants |
| Start Date | 2008-03 |
| Est. Completion | 2012-02 |
| Phase | Phase 3 |
What the finished NCT00604214 record still lists
NCT00604214 is an interventional study that assigns participants to a tested intervention. Its 1,696 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (120% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00604214 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00604214 about?
NCT00604214 is a clinical study titled "Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock". 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 wi...
What is the current status of trial NCT00604214?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,696 participants. The study started on 2008-03. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00604214?
The interventions under investigation include: Placebo (DRUG), Drotrecogin alfa (activated) (DRUG).
Who is sponsoring clinical trial NCT00604214?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00604214's enrollment target sits among peer trials
1,696 134th of 2000 higher than 1,867 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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