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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: Completed Phase 1 study, sponsored by Eli Lilly and Company.

NCT00034476 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 466 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (677% higher). According to ClinicalTrials.gov, the official US trial registry.

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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
Eli Lilly and Company

1,341 total trials

What the finished NCT00034476 record still lists

NCT00034476 is an interventional study that assigns participants to a tested intervention. The registered 466 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (677% higher).

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

NCT00034476 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00034476's enrollment target sits among peer trials

466 52nd of 2000 higher than 1,949 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00034476, the US trial registry maintained by the National Library of Medicine. NCT00034476 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.