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NCT00034476 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 1
Development phase
466
Enrollment target

NCT00034476 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 466 participants.

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The verdict

NCT00034476, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 1
Development phase
466 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG sPLA2 Inhibitor

Trial Details

FieldValue
Enrollment Target 466 participants
Start Date 2001-10
Est. Completion 2002-10
Phase Phase 1

Sponsor

Eli Lilly and Company

1,341 total trials

What the Registry Record Tells You About NCT00034476

The ClinicalTrials.gov registry entry for NCT00034476 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 466 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which sPLA2 Inhibitor is the first listed.

NCT00034476 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00034476 about?

NCT00034476 is a clinical study titled "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...

What is the current status of trial NCT00034476?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 466 participants. The study started on 2001-10. Estimated completion is 2002-10.

What interventions are being tested in trial NCT00034476?

The interventions under investigation include: sPLA2 Inhibitor (DRUG).

Who is sponsoring clinical trial NCT00034476?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.