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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: Clinical Trial Phase 2 study, sponsored by University of Chicago.
NCT00528580 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Normalization of vital signs for each subject enrolled. This is expressed as a mean time to normalization for each +/- standard error.
Interventions
- DRUG Simvastatin
- DRUG Identical-appearing placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
Why NCT00528580 stopped before completion
NCT00528580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 2 interventions - of which Simvastatin is the first listed.
NCT00528580 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00528580's enrollment target sits among peer trials
68 967th of 2000 higher than 1,027 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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