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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00604214 |
The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.
Condition | Intervention | Phase |
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Sepsis |
Drug: Drotrecogin alfa (activated) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock |
Estimated Enrollment: | 1500 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Drotrecogin alfa (activated)
24 mcg/kg/hr, IV, 96hr
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2: Placebo Comparator |
Drug: Placebo
0.9% sodium chloride, IV, 96 hrs
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 11940, F1K-MC-EVDP |
Study First Received: | January 24, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00604214 |
Health Authority: | United States: Food and Drug Administration |
Sepsis Septic shock |
Systemic Inflammatory Response Syndrome Drotrecogin alfa activated Sepsis Protein C |
Shock Shock, Septic Inflammation |
Anti-Infective Agents Fibrin Modulating Agents Anticoagulants Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Infection Pharmacologic Actions |