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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00034476 |
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Date of registration:
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29/04/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis
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Scientific title:
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A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis |
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Date of first enrolment:
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October 2001 |
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Target sample size:
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466 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00034476 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Belgium
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Hungary
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Netherlands
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Poland
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria: Patients must
- show evidence of acute infection
- meet specified time windows
- be 18 years of age or older
Exclusion Criteria: Patients must not
- have low white blood cell count
- have undergone certain organ transplants
- be HIV positive
- be pregnant or breast feeding
- have severe underlying medical problems
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sepsis
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Intervention(s)
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Drug: sPLA2 Inhibitor
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Secondary ID(s)
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1641
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J4A-MC-EZZI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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