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NCT00215124 · ClinicalTrials.gov registry record · Phase 1
A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction
A Phase 1 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
NCT00215124 is a Phase 1 study that has completed, run by The Cleveland Clinic.
The verdict
NCT00215124, a Phase 1 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
Study Summary
The objective is to obtain initial information regarding the safety and efficacy of the use of Filgrastim in the setting of acute myocardial infarction. The secondary objectives are to obtain information regarding the mobilization of relevant stem cell progenitor cells by Filgrastim in this setting and to obtain further clinical information that may be helpful in the assessment of safety and efficacy of this drug as utilized. It is a one center, randomized, placebo controlled, dose escalation, blinded study. It will be 2:1 randomization with 9 patients total. Filgrastim 10 mcg/kg/day will be administered SQ for 5 days vs. placebo. Primary endpoint is death /or myocardial rupture or change in left ventricular ejection fraction from baseline to 30 days. 9 pts. have already completed the first phase of the trial using Filgrastim 5 mcg/kg/day.
Interventions
- DRUG Filgrastim
Trial Details
| Field | Value |
|---|---|
| Est. Completion | 2007-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00215124
The ClinicalTrials.gov registry entry for NCT00215124 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Filgrastim is the first listed.
NCT00215124 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00215124 about?
NCT00215124 is a clinical study titled "A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction". The objective is to obtain initial information regarding the safety and efficacy of the use of Filgrastim in the setting of acute myocardial infarction. The secondary objectives are to obtain information regarding the mobilization of relevant stem cell progenitor cells by Filgrastim in this setting...
What is the current status of trial NCT00215124?
This trial is currently completed. It is a Phase 1 study. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00215124?
The interventions under investigation include: Filgrastim (DRUG).
Who is sponsoring clinical trial NCT00215124?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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