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ISRCTN
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ISRCTN74215569
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ClinicalTrials.gov identifier
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Public title
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A phase 3 study to determine the efficacy and safety of recombinant human activated protein C in severe sepsis
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Scientific title
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Acronym
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PROWESS
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Serial number at source
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F1K-MC-EVAD
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Belgium, Canada, France, Spain, United States of America
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Disease/condition/study domain
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Severe sepsis
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/07/1998
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Anticipated end date
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01/06/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1,690
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Interventions
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Recombinant human activated protein C (tradename - Xigris, generic name - drotrecogin alfa [activated]) versus placebo.
This trial took place at 164 hospitals in 11 countries.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Eli Lilly and Company (USA)
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Trial website
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Publications
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1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11236773
2. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15025782
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Contact name
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Dr
William
Macias
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Address
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DC6072
Eli Lilly and Company
307 E. McCarty St.
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City/town
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Indianapolis
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Zip/Postcode
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46285
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Country
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United States of America
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Sponsor
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Eli Lilly and Company (USA)
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Address
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DC6072
307 E. McCarty Street
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City/town
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Indianapolis
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Zip/Postcode
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46285
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Country
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United States of America
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Date applied
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06/01/2004
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Last edited
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08/08/2008
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Date ISRCTN assigned
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07/01/2004
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