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NCT00528580 · ClinicalTrials.gov registry record · Phase 2

Statins for the Early Treatment of Sepsis

A Phase 2 study, sponsored by University of Chicago.

Terminated
Registry status
Phase 2
Development phase
68
Enrollment target

NCT00528580 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 68 participants.

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The verdict

NCT00528580, a Phase 2 study, was terminated before completion, sponsored by University of Chicago.

TERMINATED
Registry status
Phase 2
Development phase
68 participants
Enrollment target

Study Summary

We propose a Phase II, randomized, placebo-controlled clinical trial to test the hypothesis that treatment with once-daily statins has a beneficial effect on inflammatory cytokines and clinical outcomes in adults hospitalized with sepsis. As our animal models suggest pretreatment with statins are required for their beneficial effects, we propose a study design intended to identify patients and initiate treatment early in their hospital stay. This Phase II study is intended to assess the feasibility of conducting a large-scale investigator-initiated translational research protocol that involves multiple clinical services within the Department of Medicine.

Interventions

  • DRUG Simvastatin
  • DRUG Identical-appearing placebo

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2008-02
Est. Completion 2011-09
Phase Phase 2

Sponsor

University of Chicago

796 total trials

What the Registry Record Tells You About NCT00528580

The ClinicalTrials.gov registry entry for NCT00528580 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Simvastatin is the first listed.

NCT00528580 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00528580 about?

NCT00528580 is a clinical study titled "Statins for the Early Treatment of Sepsis". We propose a Phase II, randomized, placebo-controlled clinical trial to test the hypothesis that treatment with once-daily statins has a beneficial effect on inflammatory cytokines and clinical outcomes in adults hospitalized with sepsis. As our animal models suggest pretreatment with statins are re...

What is the current status of trial NCT00528580?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2008-02. Estimated completion is 2011-09.

What interventions are being tested in trial NCT00528580?

The interventions under investigation include: Simvastatin (DRUG), Identical-appearing placebo (DRUG).

Who is sponsoring clinical trial NCT00528580?

This trial is sponsored by University of Chicago, which has 796 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.