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

Trial Profile

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

Discontinued
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs Drotrecogin alfa (Primary)
  • Indications Embolism and thrombosis; Septic shock
  • Focus Therapeutic Use
  • Acronyms PROWESS-SHOCK
  • Sponsors Eli Lilly
  • Most Recent Events

    • 09 Mar 2012 Planned number of patients changed from 1500 to 1696 as reported by ClinicalTrials.gov.
    • 25 Oct 2011 Status changed from recruiting to discontinued, according to an Eli Lilly media release. The PROWESS-SHOCK trial was discontinued as it failed to meet its primary endpoint. In addition, the drug is being withdrawn from all markets.
    • 25 Oct 2011 Primary endpoint 'Death-rate' has not been met, according to an Eli Lilly media release.
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