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

NCT00191724 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2009-06-24

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00191724 on ClinicalTrials.gov