NCT00191724

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

Drotrecogin Alfa (Activated) (LY203638)] Exploratory, Safety Study, Multi-Center, Randomized, Placebo-Controlled, Dose Escalating Study Design, Comparing a Standard Therapy (Enoxaparin Sodium) for Submassive Pulmonary Embolism to a Combined Therapy of Drotrecogin Alfa (Activated) Plus Enoxaparin Sodium.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Submassive Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Drotrecogin Alfa (Activated)	6 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
DRUG	Enoxaparin	1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days
DRUG	Placebo	intravenous (IV), one infusion, over 12 hours
DRUG	Drotrecogin Alfa (Activated)	12 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
DRUG	Drotrecogin Alfa (Activated)	18 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
DRUG	Drotrecogin Alfa (Activated)	24 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours

Timeline

• Start date: 2004-09-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-09-19
• Last updated: 2009-06-24
• Results posted: 2009-06-17

Locations

1 site across 1 country: Germany