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NCT02987088 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
A Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT02987088 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 120 participants.
The verdict
NCT02987088, a Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the optimal dose of sodium nitrate administered during resuscitation to achieve a plasma level of 10 μM by hospital arrival. Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV dose of sodium nitrite will achieve the optimal (based on preclinical studies) neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100 patients, we will determine whether 25 mg IV administered during resuscitation will achieve plasma nitrite levels of at least 10 μM by hospital arrival. Dose adjustments, either decreasing or increasing, will be made if necessary permitting us to determine the optimal nitrite dose needed to achieve the 10 μM plasma target. Safety data will also be collected
Interventions
- DRUG Sodium Nitrite
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2016-12 |
| Est. Completion | 2017-05-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02987088
The ClinicalTrials.gov registry entry for NCT02987088 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sodium Nitrite is the first listed.
NCT02987088 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02987088 about?
NCT02987088 is a clinical study titled "Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest". The purpose of this study is to determine the optimal dose of sodium nitrate administered during resuscitation to achieve a plasma level of 10 μM by hospital arrival. Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV dose of sodium nitrite will achieve the op...
What is the current status of trial NCT02987088?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2016-12. Estimated completion is 2017-05-02.
What interventions are being tested in trial NCT02987088?
The interventions under investigation include: Sodium Nitrite (DRUG).
Who is sponsoring clinical trial NCT02987088?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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