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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 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,696 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Drotrecogin alfa (activated)

Trial Details

FieldValue
Enrollment Target 1,696 participants
Start Date 2008-03
Est. Completion 2012-02
Phase Phase 3

Sponsor

Eli Lilly and Company

1,341 total trials

What the Registry Record Tells You About NCT00604214

The ClinicalTrials.gov registry entry for NCT00604214 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,696 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00604214 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.