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NCT04072835 · ClinicalTrials.gov registry record · Phase 3
Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303
A Phase 3 study of Paroxysmal Supraventricular Tachycardia, sponsored by Milestone Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,116
- Enrollment target
- 20
- Study locations
NCT04072835: Completed Phase 3 study of Paroxysmal Supraventricular Tachycardia, sponsored by Milestone Pharmaceuticals.
NCT04072835 is a Phase 3 study of Paroxysmal Supraventricular Tachycardia that has completed, run by Milestone Pharmaceuticals. The registered enrollment target is 1,116 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04072835, a Phase 3 study of Paroxysmal Supraventricular Tachycardia, has completed, sponsored by Milestone Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,116 participants
- Enrollment target
- 20
- Study locations
Study Summary
NODE-303 was a multi-center, open label study to evaluate the safety of etripamil NS in participants with Paroxysmal Supraventricular Tachycardia (PSVT). Participants were provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS was self-applied by the participant, when they felt the onset of PSVT symptoms. Participants self-administered etripamil NS if vagal maneuver was ineffective. After an episode of PSVT where study drug was administered, the participant returned to the investigative site and had the option to continue in NODE-303 and manage up to three subsequent episodes of PSVT with etripamil NS for a maximum of four episodes.
Primary Outcome
Number of participants with any adverse events experienced from baseline up to the final study visit including the treatment of up to 4 perceived PSVT episodes.
Conditions Studied
Interventions
- DRUG Etripamil NS
Study Locations (20)
Florida
- 1042 - Bradenton
- 1106 - Daytona Beach
- 1107 - Edgewater
- 1032 - Hialeah
- 1026 - Miami
- 1055 - Miami
- 1064 - Naples
- 1071 - North Miami Beach
- 1009 - Orlando
- 1060 - Saint Augustine
California
- 1121 - Fremont
- 1035 - Stanford
- 1023 - Vista
- 1083 - West Hills
Connecticut
- 1010 - Bridgeport
- 1066 - Trumbull
Georgia
- 1022 - Cumming
- 137 - Macon
Arizona
- 1077 - Gilbert
Colorado
- 101 - Littleton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,116 participants |
| Start Date | 2019-09-23 |
| Est. Completion | 2023-01-26 |
| Phase | Phase 3 |
What the finished NCT04072835 record still lists
NCT04072835 is an interventional study that assigns participants to a tested intervention. Its 1,116 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 (45% higher).
The record links to 1 condition, with Paroxysmal Supraventricular Tachycardia appearing as the primary indexed condition, and to 1 intervention - of which Etripamil NS is the first listed.
NCT04072835 names 20 study sites across 6 states, led by Florida, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04072835 about?
NCT04072835 is a clinical study titled "Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303". NODE-303 was a multi-center, open label study to evaluate the safety of etripamil NS in participants with Paroxysmal Supraventricular Tachycardia (PSVT). Participants were provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS was self-applied by the part...
What is the current status of trial NCT04072835?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,116 participants. The study started on 2019-09-23. Estimated completion is 2023-01-26.
What conditions does trial NCT04072835 study?
This clinical trial studies the following conditions: Paroxysmal Supraventricular Tachycardia.
What interventions are being tested in trial NCT04072835?
The interventions under investigation include: Etripamil NS (DRUG).
Who is sponsoring clinical trial NCT04072835?
This trial is sponsored by Milestone Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04072835 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04072835's enrollment target sits among peer trials
1,116 251st of 2000 higher than 1,750 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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