Main
|
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: |
|
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)
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|