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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 13 January 2015
Main ID:  ISRCTN74215569
Date of registration: 07/01/2004
Prospective Registration: No
Primary sponsor: Eli Lilly and Company (USA)
Public title: A phase 3 study to determine the efficacy and safety of recombinant human activated protein C in severe sepsis
Scientific title:
Date of first enrolment: 01/07/1998
Target sample size: 1690
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN74215569
Study type:  Interventional
Study design:  Randomised controlled trial (Treatment)  
Phase: 
Countries of recruitment
Belgium Canada France Spain United States of America
Contacts
Name: William    Macias
Address:  DC6072 Eli Lilly and Company 307 E. McCarty St. 46285 Indianapolis United States of America
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Not provided at time of registration
Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Severe sepsis
Infections and Infestations
Sepsis
Intervention(s)
Recombinant human activated protein C (tradename - Xigris, generic name - drotrecogin alfa [activated]) versus placebo.

This trial took place at 164 hospitals in 11 countries.
Primary Outcome(s)
Not provided at time of registration
Secondary Outcome(s)
Not provided at time of registration
Secondary ID(s)
F1K-MC-EVAD
Source(s) of Monetary Support
Eli Lilly and Company (USA)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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