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NCT01401647 · ClinicalTrials.gov registry record · Phase 3
Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
A Phase 3 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,024
- Enrollment target
NCT01401647: Completed Phase 3 study, sponsored by University of Washington.
NCT01401647 is a Phase 3 study that has completed, run by University of Washington. The registered enrollment target is 3,024 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (292% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01401647, a Phase 3 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,024 participants
- Enrollment target
Study Summary
The primary objective of the trial is to determine if survival to hospital discharge is improved with early therapeutic administration of a new Captisol-Enabled formulation of IV amiodarone (Nexterone-PM101) compared to placebo.
Primary Outcome
Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital.
Interventions
- DRUG Lidocaine
- OTHER Normal saline
- DRUG amiodarone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,024 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT01401647 record still lists
NCT01401647 is an interventional study that assigns participants to a tested intervention. Its 3,024 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (292% higher).
The record links to 0 conditions, and to 3 interventions - of which Lidocaine is the first listed.
NCT01401647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01401647 about?
NCT01401647 is a clinical study titled "Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia". The primary objective of the trial is to determine if survival to hospital discharge is improved with early therapeutic administration of a new Captisol-Enabled formulation of IV amiodarone (Nexterone-PM101) compared to placebo.
What is the current status of trial NCT01401647?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,024 participants. The study started on 2012-05. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01401647?
The interventions under investigation include: Lidocaine (DRUG), Normal saline (OTHER), amiodarone (DRUG).
Who is sponsoring clinical trial NCT01401647?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01401647's enrollment target sits among peer trials
3,024 79th of 2000 higher than 1,922 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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