Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study

NCT00191724 ↗

Phase 2 Completed 47 enrolled Eli Lilly and Company

RandomizedParallel-groupDouble-blindTreatment

Summary

An exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation study comparing a standard therapy for submassive pulmonary embolism (Enoxaparin sodium) to a combined therapy of Drotrecogin alfa (activated) plus Enoxaparin sodium.

Timeline

Start: 2004-09
Primary completion: 2008-01
Completion: 2008-01

Publications

Dempfle CE, Elmas E, Link A, Suvajac N, Liebe V, Janes J, Borggrefe M. Endogenous plasma activated protein C levels and the effect of enoxaparin and drotrecogin alfa (activated) on markers of coagulation activation and fibrinolysis in pulmonary embolism. Crit Care. 2011;15(1):R23. doi: 10.1186/cc9968. Epub 2011 Jan 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Drotrecogin alfa (activated)	Protein / enzyme biologic	6 ug/kg	Intravenous
Subject	Drotrecogin alfa (activated)	Protein / enzyme biologic	12 ug/kg	Intravenous
Subject	Drotrecogin alfa (activated)	Protein / enzyme biologic	18 ug/kg	Intravenous
Subject	Drotrecogin alfa (activated)	Protein / enzyme biologic	24 ug/kg	Intravenous
Background	Enoxaparin sodium	Other / unclassified	1 mg/kg	Subcutaneous

Indications

No indication recorded.