Trial · NCT03464019
Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT).
NCT03464019, Phase 3, Terminated, Milestone Pharmaceuticals Inc.; results first posted 2024-07-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT). Trials, record NCT03464019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03464019
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT).
- NCT number
- NCT03464019
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,097 participants, actual
- Lead sponsor
- Milestone Pharmaceuticals Inc.
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Interventions
- Etripamil, Placebo, Etripamil Test Dose
- First posted
- 2018-03-13
- Last updated
- 2024-07-12
- Other registries' IDs
- eudract:2018-000308-41
- Results first posted
- 2024-07-12
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. | NODE-301 Part 1: Within 5 hours of start of study drug dosing. NODE-301 Parts 2 and 3: Within 30 minutes of start of study drug dosing. | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. | NODE-301 Part 1: Within 5 hours of start of study drug dosing. NODE-301 Parts 2 and 3: Within 30 minutes of start of study drug dosing. | In NODE-301 Part 1, the efficacy population consisted of 156 participants (37.2% of the 419 randomized participants).~In NODE-301 Parts 2 and 3, the efficacy population consisted of 214 participants (29.1% of the 735 randomized participants). The efficacy population was a modified intent-to-treat (mITT) population that included all participants who took study drug to treat an episode of perceived PSVT that was adjudicated by the Independent Adjudication Committee to be confirmed PSVT. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. | Part 1 - Placebo Single Dose | Part 1: Participants converted to sinus rhythm within 5 hours | 36 | Participants | |
| The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. | Part 1 - Etripamil 70 mg | Part 1: Participants converted to sinus rhythm within 5 hours | 80 | Participants | |
| The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. | Part 1 - Placebo Single Dose | Part 1: Participants censored | 13 | Participants | |
| The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. | Part 1 - Etripamil 70 mg | Part 1: Participants censored | 27 | Participants | |
| The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo | Parts 2 and 3: Participants converted to sinus rhythm within 30 minutes | 30 | Participants | |
| The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg | Parts 2 and 3: Participants converted to sinus rhythm within 30 minutes | 75 | Participants | |
| The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo | Parts 2 and 3: Participants censored | 70 | Participants | |
| The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg | Parts 2 and 3: Participants censored | 39 | Participants |
Source ClinicalTrials.gov
Participant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| NODE-301 Part 1 | STARTED | Placebo | 60 | |
| NODE-301 Part 1 | STARTED | Etripamil | 138 | |
| NODE-301 Part 1 | STARTED | Test Dose Only | 233 | |
| NODE-301 Part 1 | Participants Randomized | Placebo | 60 | |
| NODE-301 Part 1 | Participants Randomized | Etripamil | 138 | |
| NODE-301 Part 1 | Participants Randomized | Test Dose Only | 233 | |
| NODE-301 Part 1 | Participants in Efficacy Population | Placebo | 49 | |
| NODE-301 Part 1 | Participants in Efficacy Population | Etripamil | 107 | |
| NODE-301 Part 1 | Participants in Efficacy Population | Test Dose Only | 0 | |
| NODE-301 Part 1 | COMPLETED | Placebo | 60 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events228
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Supraventricular tachycardia | Cardiac disorders | Part 1 - Placebo Single Dose | 0 | 60 | |
| other | Supraventricular tachycardia | Cardiac disorders | Part 1 - Etripamil 70 mg | 0 | 138 | |
| other | Supraventricular tachycardia | Cardiac disorders | Part 1 - Test Dose Only | 0 | 233 | |
| other | Supraventricular tachycardia | Cardiac disorders | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo + Open-label Etripamil | 11 | 143 | |
| other | Supraventricular tachycardia | Cardiac disorders | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg + Open-label Etripamil | 5 | 160 | |
| other | Supraventricular tachycardia | Cardiac disorders | Parts 2 and 3 - Test Dose Only (2X70 mg) | 8 | 445 | |
| other | Atrial fibrillation | Cardiac disorders | Part 1 - Placebo Single Dose | 4 | 60 | |
| other | Atrial fibrillation | Cardiac disorders | Part 1 - Etripamil 70 mg | 0 | 138 | |
| other | Atrial fibrillation | Cardiac disorders | Part 1 - Test Dose Only | 1 | 233 | |
| other | Atrial fibrillation | Cardiac disorders | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo + Open-label Etripamil | 1 | 143 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 - Placebo Single Dose | 0 | 60 |
| Total, all-cause mortality | Part 1 - Etripamil 70 mg | 0 | 138 |
| Total, all-cause mortality | Part 1 - Test Dose Only | 0 | 233 |
| Total, all-cause mortality | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo + Open-label Etripamil | 0 | 143 |
| Total, all-cause mortality | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg + Open-label Etripamil | 0 | 160 |
| Total, all-cause mortality | Parts 2 and 3 - Test Dose Only (2X70 mg) | 1 | 445 |
| Total, other adverse events | Part 1 - Placebo Single Dose | 39 | 60 |
| Total, other adverse events | Part 1 - Etripamil 70 mg | 98 | 138 |
| Total, other adverse events | Part 1 - Test Dose Only | 151 | 233 |
| Total, other adverse events | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo + Open-label Etripamil | 114 | 143 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03464019
GET https://conductscience.org/api/trials/v1/NCT03464019/flow?page=2