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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 is a Phase 3 study of Paroxysmal Supraventricular Tachycardia that has completed, run by Milestone Pharmaceuticals. The registered enrollment target is 1,116 participants. The trial reports 20 study locations across 6 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04072835
The ClinicalTrials.gov registry entry for NCT04072835 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,116 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 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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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