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A phase 3 study to determine the efficacy and safety of recombinant human activated protein C in severe sepsis
ISRCTN ISRCTN74215569
DOI 10.1186/ISRCTN74215569
ClinicalTrials.gov identifier
EudraCT number
Public title A phase 3 study to determine the efficacy and safety of recombinant human activated protein C in severe sepsis
Scientific title
Acronym PROWESS
Serial number at source F1K-MC-EVAD
Study hypothesis Not provided at time of registration
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Belgium, Canada, France, Spain, United States of America
Disease/condition/study domain Severe sepsis
Participants - inclusion criteria Not provided at time of registration
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/07/1998
Anticipated end date 01/06/2000
Status of trial Completed
Patient information material
Target number of participants 1,690
Interventions 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 measure(s) Not provided at time of registration
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Eli Lilly and Company (USA)
Trial website
Publications 1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11236773
2. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15025782
Contact name Dr  William  Macias
  Address DC6072
Eli Lilly and Company
307 E. McCarty St.
  City/town Indianapolis
  Zip/Postcode 46285
  Country United States of America
Sponsor Eli Lilly and Company (USA)
  Address DC6072
307 E. McCarty Street
  City/town Indianapolis
  Zip/Postcode 46285
  Country United States of America
Date applied 06/01/2004
Last edited 08/08/2008
Date ISRCTN assigned 07/01/2004
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