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A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00034476
First received: April 29, 2002
Last updated: July 18, 2006
Last verified: July 2006

April 29, 2002
July 18, 2006
October 2001
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Complete list of historical versions of study NCT00034476 on ClinicalTrials.gov Archive Site
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A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis
A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis

The purpose of this study is to determine whether the administration of the study drug is effective in increasing the chance of survival in patients with severe sepsis. Patients entered into this study will be randomly assigned to one of two treatment groups. Patients in each treatment group will be given either the study drug or placebo as a continuous infusion directly into the bloodstream through a catheter placed in one of the patient's veins.

The study drug is an investigational drug that is still in development. It has been studied in approximately 30 healthy subjects, approximately 30 patients with either kidney failure or arthritis, and approximately 600 patients with severe sepsis. Patient participation in this study will last for about one month.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Sepsis
Drug: sPLA2 Inhibitor
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
466
October 2002
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Hungary,   Netherlands,   Poland
 
NCT00034476
1641, J4A-MC-EZZI
Not Provided
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Eli Lilly and Company
Not Provided
Not Provided
Eli Lilly and Company
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP