Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxymal Supraventricular Tachycardia (PSVT). NODE 301 [Part 1 and Part 2 (RAPID Study)]

Paroxysmal Supraventricular Tachycardia Clinical Trial

Official title:

Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. NODE 301 Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464019
• Other study ID #: MSP-2017-1138
• Status: Completed
• Phase: Phase 3
• Start date: June 18, 2018
• Est. completion date: January 20, 2023

Study information

• Verified date: January 2024
• Source: Milestone Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a two-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by patients who experience an episode of paroxysmal ventricular tachycardia (PSVT) in an at-home setting.

Part 1 comprised the conduct of the NODE-301 study up to the date of the adjudication of 150th positively adjudicated PSVT episode and Part 2 comprises the conduct of the NODE-301 study after the completion of Part 1.

The RAPID Study (NODE-301 - Part 2) will enroll patients enrolled during Part 1 who had not dosed with the double-blind study drug, or had not discontinued the study before the adjudication of the 150th positively adjudicated PSVT episode in Part 1, and patients enrolled into the study following the completion of Part 1. The study will continue for approximately 6 months after the date of the adjudication of the 180th positively adjudicated PSVT episode (the data on which the primary efficacy analysis of RAPID will be conducted).

The study will include the following visits: A Screening Visit, A Test Dose Randomization Visit, Monthly Follow-up Visits, A Randomized Treatment Period, A Randomized Treatment Period Follow-Up Visit, An Open-Label Treatment Period, and A Final Study Visit.

Description:

NODE-301 is a two-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by patients who experience an episode of paroxysmal ventricular tachycardia (PSVT) in an at-home setting. Each episode will be documented by an ambulatory Cardiac Monitoring System (CMS) that will be placed on the chest by the patient or caregiver when symptoms begin and will record at least 5 hours of continuous electrocardiogram (ECG).

This is an event-driven study. The study is comprised of 2 parts: Part 1 and Part 2.

Part 1 comprised the conduct of NODE-301 up to the date of the adjudication of the 150th positively adjudicated PSVT episode (January 15th, 2020). Part 1 had the same general study design as Part 2 of the study, with the key differences being that Part 2 includes a repeat dosing option during the randomized treatment phase, as well as during an added open-label treatment phase.

Part 2 (the RAPID Study) describes the conduct of NODE-301 following the completion of Part

1. RAPID will enroll patients enrolled during Part 1 who had not dosed with the double-blind study drug, or had not discontinued the study before the adjudication of the 150th positively adjudicated PSVT episode in Part 1, and patients enrolled into the study following the completion of Part 1. The RAPID study will continue for approximately 6 months after the date of the adjudication of the 180th positively adjudicated PSVT episode (the data on which the study's primary efficacy analysis will be performed).

Before randomization in the RAPID study, all patients will receive a test dose of an etripamil NS dosing regimen (an initial dose of etripamil NS 70 mg followed by a second dose of etripamil NS 70 mg not earlier than 10 minutes and not later than 15 minutes after the first dose) to evaluate tolerability and to train patients on the study procedures.

The RAPID Study includes a Screening Visit, a Test Dose Randomization Visit, Monthly Follow-up Visits, a Randomized Treatment Period, a Randomized Treatment Period Follow-Up Visit, an Open-Label Treatment Period, and a Final Study Visit.

Study comprised of 4 arms:

• 2 arms consisting of patients enrolled during Part 1 randomized 2:1 to a single dose of study drug (etripamil NS 70 mg or placebo) to treat a perceived episode of PSVT

• 2 arms consisting of newly enrolled patients who pass a test dose regimen of etripamil NS 70 mg, randomized 1:1 to a dosing regimen of etripamil or placebo that allows patients to self-administer a second dose (not earlier than 10 minutes and not later than 15 minutes after the first dose) of study drug if symptoms are still present at 10 minutes, to treat a perceived PSVT episode.

Safety will be monitored during the treatment periods.

To ensure the safety of trial participants in RAPID, new processes or modification of listed processes may be put in place to reduce the risks associated with the COVID-19 pandemic. These potential changes include, but are not limited to, the use of tele-medicine to conduct study visit procedures, conduct of study procedures outside of the clinical site (i.e., at a patient's home) by site personnel or by trained but non-study personnel, and the distribution of investigational products by alternative secure delivery methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 748
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients who meet all of the following criteria will be eligible to participate in the study:

1. Male or female patients at least 18 years of age;

2. Electrographically documented history of PSVT (e.g., electrocardiogram [ECG] obtained during an episode of PSVT, Holter monitoring, loop recorder, etc). If patient had a prior ablation for PSVT, patient must have documented ECG evidence of PSVT post-ablation;

3. History of sustained episodes of PSVT (i.e., typically lasting approximately 20 minutes or longer);

4. Females of childbearing potential who are sexually active with a male partner who is not surgically sterile (i.e., vasectomy) must agree to use a highly effective form of contraception from the time of signed informed consent until 30 days after the last administration of study drug. Females of childbearing potential should have a negative serum pregnancy test result at the Screening Visit and at the Final Study Visit, a negative urine pregnancy test at the Test Dose Randomization Visit and must use a highly effective form of contraception between the visits.

The following categories define females who are NOT considered to be of childbearing potential:

• Premenopausal females with 1 of the following:

1. Documented hysterectomy,

2. Documented bilateral salpingectomy or tubal ligation; or

3. Documented bilateral oophorectomy, or

• Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause;

5. Male patients, except those who are surgically sterile, must use an approved highly effective form of contraception during the 3 days after any study drug administration; and

6. Signed written informed consent.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from participation in the study:

1. Systolic blood pressure <90 mmHg after a 5-minute rest in sitting position at the Screening Visit or before the test dose. In patients treated with a chronic prophylactic drug for PSVT (e.g., beta-blockers, verapamil, and diltiazem), the drug may be stopped for at least the equivalent of 5 half-lives, patients may be rescreened once, and chronic use of the drug cannot be restarted after randomization;

2. History of severe symptoms of hypotension, especially syncope, during episodes of PSVT;

3. History of atrial arrhythmia that does not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, intra-atrial tachycardia);

4. History of allergic reaction to verapamil;

5. Current therapy with digoxin or any Class I or III antiarrhythmic drug, except if these drugs are stopped at least the equivalent of 5 half-lives before the Test Dose Randomization Visit;

6. Current chronic therapy with oral amiodarone, or have taken oral amiodarone within 30 days prior to the Test Dose Randomization Visit;

7. Evidence of ventricular pre-excitation (e.g., delta waves, short PR interval <100 msec, Wolff-Parkinson-White syndrome) on the ECG performed at the Screening Visit or before the test dose administration;

8. Evidence of a second- or third-degree AV block on the ECG performed at the Screening Visit or before the test dose administration;

9. History or evidence of severe ventricular arrhythmia (e.g., torsades de pointes, ventricular fibrillation, or ventricular tachycardia);

10. Current congestive heart failure defined by the New York Heart Association Class II to IV;

11. History of Acute Coronary Syndrome or stroke within 6 months of screening;

12. Evidence of hepatic dysfunction defined as alanine aminotransferase or aspartate aminotransferase >3 × the upper limit of normal (ULN) or total bilirubin >2 × ULN at the Screening Visit, unless due to Gilbert syndrome;

13. Evidence of End-Stage Renal Disease as determined by an estimated glomerular filtration rate assessed at the Screening Visit of <15 mL/min/1.73m2, or requiring hemodialysis;

14. Females who are pregnant or lactating;

15. Evidence or history of any significant physical or psychiatric condition including drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of patients, or affect their participation in the study. Additionally, the Investigator has the ability to exclude a patient if for any reason the Investigator judges the patient is not a good candidate for the study or will not be able to follow study procedures;

16. Participation in any investigational drug or device study or the use of any investigational drug or device within 30 days of the Screening Visit; or

17. Previously enrolled in a clinical trial for etripamil and received study drug during a perceived episode of PSVT.

Before randomization in the RAPID study, all patients will receive a test dose of an etripamil NS dosing regimen (an initial dose of etripamil NS 70 mg followed by a second dose of etripamil NS 70 mg not earlier than 10 minutes and not later than 15 minutes after the first dose) to evaluate tolerability and to train patients on the study procedures. Both doses of the etripamil dosing regimen must be administered for the test dose to be considered evaluable. A failure of the test dose is considered if patients meet any of the following criteria occurring after administration of the either the first or second dose of etripamil NS 70 mg:

1. Any symptoms consistent with clinically severe hypotension such as pre-syncope, medically significant lightheadedness, syncope, nausea, or vomiting;

2. For patients with a pre-test dose Systolic Blood Pressure above 100 mmHg:

1. Decrease in SBP =40 mmHg after test dose; or

2. Post-test dose SBP <80 mmHg;

3. For patients with a pre-test dose SBP between 90 mmHg and 100 mmHg (inclusive):

a) Post-test dose SBP <75 mmHg;

4. Third-degree AV block, Mobitz II second-degree AV block, or Wenckebach with bradycardia =40 bpm;

5. New, significant sinus bradycardia Heart Rate =40 bpm or sinus pauses (=3 seconds), if considered by the Investigator to put the patient's safety at risk if either were to occur while not under medical supervision;

6. Any new ventricular arrhythmia considered significant by the Investigator; or

7. Atrial fibrillation, atrial flutter or atrial tachycardia (event lasting longer than 30 seconds);

8. Refusal of second dose of etripamil test dose regimen.

Patients who fail the test dose will proceed in the study as follows:

• If the Investigator identifies a possible reversible cause of the initial test dose failure (e.g., concomitant medication such as beta-blocker), a re-challenge with a new test dose of etripamil NS 70 mg will be possible after elimination of the reversible cause (e.g., withdrawal of concomitant therapy with the appropriate washout period). Patients may be randomized if they pass the second test dose and the cause of the test dose failure is eliminated for the duration of the study; or

• If the Investigator cannot identify a reversible cause of the initial test dose failure, or if the potential cause cannot be modified (e.g., necessary antihypertensive drug to control blood pressure), patients will not be randomized and will complete a Final Study Visit. Patients who fail the test dose will be part of the Test Dose Only Population.

Related Conditions & MeSH terms

• Paroxysmal Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Supraventricular
• Tachycardia, Ventricular

Intervention

Drug:
• Etripamil
Etripamil will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
• Placebo
Placebo will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
• Etripamil
During the Open Label Treatment phase, etripamil will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.

Locations

Country	Name	City	State
Belgium	Clinique Du Sud- Luxembourg	Arlon
Belgium	Imelda Hospital	Bonheiden
Belgium	Universite Libre de Bruxelles (ULB) - Hopital Erasme	Bruxelles
Belgium	UVC Brugmann University Hospital - Centre Hospitalier Universitaire (CHU)	Bruxelles
Belgium	Antwerp University Hospital (UZA)	Edegem
Belgium	Grand Hopital de Charleroi (GHdC) - Site Saint-Joseph	Gilly
Belgium	Pharmacy Campus Virga Jesse (losplaats 7)	Hasselt
Belgium	University Hospital (UZ) Leuven	Leuven
Belgium	Regional Hospital Centre Citadelle	Liège
Belgium	CHU Ambroise Pare	Mons
Belgium	CHU UCL Namur - Site Godinne	Yvoir
Canada	Libin Cardiovascular Institute of Alberta - University of Calgary	Calgary	Alberta
Canada	Cambridge Cardiac Care Centre	Cambridge	Ontario
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	Dawson Road Medical Centre	Guelph	Ontario
Canada	Dalhousie University - QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	CHUM Recherche Cardiologie	Montreal	Quebec
Canada	The Montreal Heart Institute	Montreal	Quebec
Canada	McGill University Health Center - Research Institute	Montréal	Quebec
Canada	Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic	Newmarket	Ontario
Canada	Medical Arts Health Research Group - North Vancouver	North Vancouver	British Columbia
Canada	Institut Universitaire de Cardiologie et de Pneumologie De Quebec	Québec	Quebec
Canada	CardioVasc HR	Saint-Jean-sur-Richelieu	Quebec
Canada	CIUSSS de l'Estrie - CHUS	Sherbrooke	Quebec
Canada	CSSS du Sud de Lanaudiere - Hopital Pierre Le Gardeur	Terrebonne	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Vancouver Coastal Health Research	Vancouver	British Columbia
Canada	Victoria Cardiac Arrhythmia Trials, Inc.	Victoria	British Columbia
Canada	University of Manitoba, St Boniface General Hospital	Winnipeg	Manitoba
France	CHRU Besancon - Hopital Jean Minjoz	Besançon	Besancon
France	CHRU de Brest - Hopital de la Cavale Blanche	Brest
France	HCL Hopital Louis Pradel	Bron
France	Hopital Saint-Louis de La Rochelle	La Rochelle
France	CHU Grenoble-Alpes - Hopital Michallon	La Tronche	Grenoble
France	CHU de Lille - Institut Cœur Poumon	Lille
France	Centre Hospitalier de Pau	Pau
Germany	Vivantes Klinikum Neukoelln	Berlin
Germany	FAZ Dresden-Neustadt GbR	Dresden
Germany	Kardiologische Praxis	Dresden
Germany	Maerkische Gesundheitsholding GmbH - Klinikum Luedenscheid	Lüdenscheid	Ludenscheid
Germany	Peter Osypka Herzzentrum Munchen	München	Munchen
Germany	Kardiologische Gemeinschaftspraxis Papenburg	Papenburg
Germany	Zentrum fuer Praevention und Rehabilitation	Siegen
Hungary	Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo	Bekescsaba	Bekescaba
Hungary	Del-pesti Centrumkorhaz	Budapest
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest
Hungary	Debreceni Egyetem Klinikai	Debrecen
Hungary	Nehezlegzes Ambulancia	Debrecen	Debrecon
Hungary	CRU Hungary Kft.	Encs
Hungary	Belvarosi Egeszseghaz	Zalaegerszeg
Netherlands	Meander Medisch Centrum - Locatie Amersfoort	Amersfoort
Netherlands	Ziekenhuis Rijnstate - Locatie Arnhem	Arnhem
Netherlands	Rode Kruis Ziekenhuis	Beverwijk
Netherlands	Tergooiziekenhuizen Blaricum	Blaricum
Netherlands	Amphia Ziekenhuis - Locatie Breda Molengracht	Breda
Netherlands	IJsselland ziekenhuis	Capelle Aan Den IJssel
Netherlands	Reinier de Graaf Gasthuis	Delft
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Slingeland Ziekenhuis	Doetinchem
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Ropcke-Zweers Ziekenhuis	Hardenberg
Netherlands	Treant Zorggroep	Hoogeveen
Netherlands	Alrijne Ziekenhuis	Leiderdorp
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Franciscus Gasthuis & Vlietland - Locatie Vlietland	Schiedam
Netherlands	Diakonessenhuis - Locatie Utrecht	Utrecht
Netherlands	Jeroen Bosch Ziekenhuis	Utrecht
Poland	Centrum Medyczne Kermed	Bydgoszcz
Poland	MICS Centrum Medyczne Torun	Bydgoszcz
Poland	Specjalistyczna Praktyka Lekarska	Katowice
Poland	American Heart of Poland S.A., IV Oddzial Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii	Kedzierzyn-Kozle	Kedzierzyn Kozle
Poland	Gabinety Daszmed	Kraków	Krakov
Poland	Prywatny Specjalistyczny Gabinet Internistyczny	Libiaz
Poland	Instytut Centrum Zdrowia Matki Polki	Lódz	Lodz
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi	Lódz	Lodz
Poland	MEDICOME Sp. z o.o.	Oswiecim
Poland	SP ZOZ Szpital Specjalistyczny w Pulawach	Pulawy
Poland	Kliniczny Szpital Wojewódzki nr 2, Rzeszów	Rzeszów	Rzeszow
Poland	NZOZ Pro Cordis Sopockie Centrum Badan Kardiologicznych	Sopot
Poland	Osrodek Badan Klinicznych CLINSANTE S.C.	Torun
Poland	X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji	Tychy
Poland	Kardiosystem	Warsaw
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Universitario Reina Sofia	Córdoba	Cordoba
Spain	Hospital Clinico Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves	Granada
Spain	Martínez Hervás Cardiólogos	Granada	Andalucia
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda
Spain	Hospital Universitario Virgen de la Victoria	Málaga	Malaga
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Complejo Hospitalario de Navarra	Pamplona
Spain	Hospital Universitari Sant Joan de Reus	Reus
Spain	Hospital Universitario la Paz Rua Choupana	Santiago De Compostela
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital General Universitario de Valencia (HGUV)	Valencia	Comunidad Valenciana
Spain	Hospital Alvaro Cunqueiro	Vigo	Pontevedra
Spain	Hospital Universitario Clínico Lozano Blesa	Zaragoza
United States	North Texas Research Associates	Allen	Texas
United States	MedStar Health Research Institute - Chesapeake Cardiovascular Associates	Baltimore	Maryland
United States	FWD Clinical Research	Boca Raton	Florida
United States	St. Luke's Idaho Cardiology Associates	Boise	Idaho
United States	Montefiore Medical Center	Bronx	New York
United States	Cary Research Group, LLC	Cary	North Carolina
United States	Medvin Clinical Research	Cerritos	California
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Sanger Heart and Vascular Institute	Charlotte	North Carolina
United States	The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute	Charlotte	North Carolina
United States	Hatton Institute for Research & Education, Trihealth, Inc. - Cardiology	Cincinnati	Ohio
United States	Prisma Health Midlands	Columbia	South Carolina
United States	IACT Health	Columbus	Georgia
United States	The Ohio State University (OSU) Wexner Medical Center	Columbus	Ohio
United States	Cardiovascular Clinic of North Texas	Denton	Texas
United States	Revival Research Institute, LLC	Denton	Texas
United States	AMITA Health Medical Group Heart & Vascular Elk Grpve Village	Elk Grove Village	Illinois
United States	Cardiovascular Associates of the Delaware Valley - Elmer	Elmer	New Jersey
United States	North Coast Cardiolog	Encinitas	California
United States	Titan Medical Research - Oceanside	Encinitas	California
United States	Piedmont Heart Institute- Fayetteville	Fayetteville	Georgia
United States	Piedmont Heart Institute-Fayetteville	Fayetteville	Georgia
United States	Parkview Physicians Group - Cardiology	Fort Wayne	Indiana
United States	Apex Trials Group	Fort Worth	Texas
United States	Cardiovascular Associates of the Delaware Valley	Haddon Heights	New Jersey
United States	Angiocardiac Care of Texas	Houston	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Idaho Catalyst Clinical Research	Idaho Falls	Idaho
United States	Baptist Health Ambulatory Services d/b/a	Jacksonville	Florida
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Arkansas Cardiology	Little Rock	Arkansas
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	South Denver Cardiology Associates, P.C	Littleton	Colorado
United States	Los Alamitos Cardiovascular	Los Alamitos	California
United States	Georgia Arrythmia Consultants&Research Institute	Macon	Georgia
United States	Rama Research LLC	Marion	Ohio
United States	United Health Research, LLC	Miami	Florida
United States	Atlantic Health System - Morristown Medical Center	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	Columbia University	New York	New York
United States	New York Presbyterian Hospital/Weill Cornell Medical Center	New York	New York
United States	Amicis Research Center - Northridge	Northridge	California
United States	Cardiology Associates of Fairfield County	Norwalk	Connecticut
United States	RESPIRE Research	Palm Springs	California
United States	Arizona Arrhythmia Research Center	Phoenix	Arizona
United States	Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc	Rapid City	South Dakota
United States	Mercy Research	Saint Louis	Missouri
United States	Revival Research Institute, LLC - Southgate, MI	Southgate	Michigan
United States	Heart House Research Foundation, LLC	Springfield	Ohio
United States	Scott & White Memorial Hospital: Baylor Scott & White Research Institute	Temple	Texas
United States	ProMedica Toledo Hospital	Toledo	Ohio
United States	Bay Area Heart	Webster	Texas
United States	Mercy One Iowa Heart Center	West Des Moines	Iowa
United States	Clinical Trials of America, LLC - Monroe, LA	West Monroe	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Milestone Pharmaceuticals Inc.	IQVIA Biotech, Medpace, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Hungary,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The percentage of patients requiring additional medical intervention to terminate an episode of PSVT.		Within 5 hours after administration of study drug
Other	The repeat of key efficacy endpoints in various subgroups of interest (e.g., concomitant medications).		Within 5 hours after administration of study drug
Primary	The time to conversion of an episode of PSVT to sinus rhythm (SR) after study drug administration.	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 30 minutes of start of study drug dosing.	Within 30 minutes of start of study drug dosing.
Secondary	Time to conversion at time points prior to, and later than, 30 minutes.		From 10 minutes to 300 minutes after start of study drug dosing.
Secondary	Relief of specific symptoms (i.e., heart palpitations, rapid pulse feeling, chest pain, anxiety, shortness of breath, dizziness, and fainting) potentially associated with an episode of PSVT.		Completed as soon as possible after termination of the treated PSVT episode
Secondary	Rating of Treatment Satisfaction Questionnaire for Medication (TSQM-9).		Completed as soon as possible after termination of the treated PSVT episode