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NCT03464019 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT).
A Phase 3 study, sponsored by Milestone Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,097
- Enrollment target
NCT03464019: Clinical Trial Phase 3 study, sponsored by Milestone Pharmaceuticals.
NCT03464019 is a Phase 3 study that was terminated before completion, run by Milestone Pharmaceuticals. The registered enrollment target is 1,097 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03464019, a Phase 3 study, was terminated before completion, sponsored by Milestone Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,097 participants
- Enrollment target
Study Summary
This was a three-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by participants who experienced an episode of paroxysmal supraventricular tachycardia (PSVT) in an at-home setting. NODE-301 Part 1 included participants that received the randomized study drug to treat an episode of PSVT until the 150th positively adjudicated PSVT episode. Part 2 (also referred as the RAPID study) included participants that did not receive the randomized study drug in Part 1 and newly enrolled participants until the 180th positively adjudicated PSVT episode in Part 2. The study continued for approximately 6 months after the 180th positively adjudicated PSVT episode in Part 2 and this extension is referred to as Part 3 (also referred to as RAPID Extension).
Primary Outcome
The primary efficacy endpoint is defined as an adjudicated termination of a positively adjudicated episode of PSVT (AV nodal reentrant tachycardia or AV reentrant tachycardia determination if possible) and conversion to sinus rhythm (SR) for at least 30 seconds within 5 hours (NODE-301 Part 1), or 30 minutes (NODE-301 Parts 2 and 3) of start of study drug dosing.
Interventions
- DRUG Placebo
- DRUG Etripamil
- DRUG Etripamil Test Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,097 participants |
| Start Date | 2018-06-18 |
| Est. Completion | 2023-01-20 |
| Phase | Phase 3 |
Why NCT03464019 stopped before completion
NCT03464019 is an interventional study that assigns participants to a tested intervention. Its 1,097 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 (42% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03464019 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03464019 about?
NCT03464019 is a clinical study titled "Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT).". This was a three-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by participants who experienced an episode of paroxysmal supraventricular tachycardia (PSVT) in an at-home setting. NODE-301 Pa...
What is the current status of trial NCT03464019?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,097 participants. The study started on 2018-06-18. Estimated completion is 2023-01-20.
What interventions are being tested in trial NCT03464019?
The interventions under investigation include: Placebo (DRUG), Etripamil (DRUG), Etripamil Test Dose (DRUG).
Who is sponsoring clinical trial NCT03464019?
This trial is sponsored by Milestone Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03464019's enrollment target sits among peer trials
1,097 265th of 2000 higher than 1,736 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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