A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis
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|ClinicalTrials.gov Identifier: NCT00034476|
Recruitment Status : Completed
First Posted : April 30, 2002
Last Update Posted : July 19, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Drug: sPLA2 Inhibitor||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||466 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis|
|Study Start Date :||October 2001|
|Estimated Study Completion Date :||October 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00034476
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