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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 is a Phase 3 study that was terminated before completion, run by Milestone Pharmaceuticals. The registered enrollment target is 1,097 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03464019
The ClinicalTrials.gov registry entry for NCT03464019 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,097 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milestone Pharmaceuticals, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03464019 reports 0 study locations.
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.
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