CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,696 enrolled
Drug / intervention
Drotrecogin alfa (activated) +1 moredrug
Likely dose
Drotrecogin alfa (activated) 24 microgramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00604214
NCT00604214Phase 3Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Jan 30, 2008·Updated Sep 18, 2012

In Brief

A Phase 3 clinical trial evaluating Drotrecogin alfa (activated) and Placebo for Sepsis. Completed, enrolled 1,696 participants across 150 sites in 18 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis
CountriesAustralia, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, India, Italy, Mexico, Netherlands, New Zealand, Portugal, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2008
Enrollment StartMar 1, 2008
Primary CompletionSep 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 18.4 years ago

Interventions

Drotrecogin alfa (activated)drug

24 microgram/kilogram/hour, intravenous, 96 hours (hr)

Placebodrug

0.9% sodium chloride, intravenous, 96 hours