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

• ClinicalTrials.gov Identifier: NCT03464019
• Recruitment Status: Completed
• First Posted: March 13, 2018
• Last Update Posted: February 14, 2023
• Sponsor: Milestone Pharmaceuticals Inc.
• Collaborators: Medpace, Inc.; IQVIA Biotech
• Information provided by (Responsible Party): Milestone Pharmaceuticals Inc.

Study Description

Brief Summary:

This is a two-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil 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. Enrollment will continue until and for approximately 6 months after the date of the adjudication of the 180th positively adjudicated PSVT episode.

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.

Condition or disease	Intervention/treatment	Phase
Paroxysmal Supraventricular Tachycardia	Drug: Etripamil; Drug: Placebo	Phase 3

Detailed Description:

NODE-301 is a two-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil 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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 701 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

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.

• Masking: Triple (Participant, Care Provider, Investigator)

Masking Description

RAPID study (NODE-301 Part 2) includes an open-label treatment phase following the randomized treatment phase of the study.

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. Patients who report no tolerability issues (i.e. adverse events) related to the study drug after having finished the Randomized Treatment Period, will be entered into the Open-Label Treatment Period while the patients who have not tolerated the double-blind study drug will pass to the Final Study Visit.

Patients comprising the single dose arms will not be entered into the open-label treatment phase of the RAPID study.

• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: June 18, 2018
• Actual Primary Completion Date: January 20, 2023
• Actual Study Completion Date: January 20, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Etripamil 70 mg Single Dose; Self- administration of a single dose of 70 mg of etripamil.	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 Comparator: Placebo Single Dose; Self- administration of a single dose of placebo.	Drug: 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.
Experimental: Etripamil 70 mg with Optional Second Dose; Dosing regimen that permits a second dose of etripamil 70 mg	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 Comparator: Placebo with Optional Second Dose; Dosing regimen that permits a second dose of placebo.	Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. The time to conversion of an episode of PSVT to sinus rhythm (SR) after study drug administration. [ Time Frame: 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 30 minutes of start of study drug dosing.

Secondary Outcome Measures :

1. 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. [ Time Frame: Completed as soon as possible after termination of the treated PSVT episode ]
2. Rating of Treatment Satisfaction Questionnaire for Medication (TSQM). [ Time Frame: Completed as soon as possible after termination of the treated PSVT episode ]

Other Outcome Measures:

1. The number of positively adjudicated episodes of PSVT terminated by a vagal maneuver (VM). [ Time Frame: Within 5 hours after administration of study drug ]
2. The percentage of patients requiring additional medical intervention to terminate an episode of PSVT. [ Time Frame: Within 5 hours after administration of study drug ]
3. The repeat of key efficacy endpoints in various subgroups of interest (e.g., concomitant medications). [ Time Frame: Within 5 hours after administration of study drug ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Arkansas

Arkansas Cardiology

Little Rock, Arkansas, United States, 72205

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

United States, California

Medvin Clinical Research

Cerritos, California, United States, 91722

North Coast Cardiolog

Encinitas, California, United States, 92024

Amicis Research Center - Northridge

Northridge, California, United States, 91324

Titan Medical Research - Oceanside

Oceanside, California, United States, 92056

United States, Colorado

South Denver Cardiology Associates, P.C

Littleton, Colorado, United States, 80120

United States, Connecticut

Cardiology Associates of Fairfield County

Norwalk, Connecticut, United States, 06905

United States, Florida

FWD Clinical Research

Boca Raton, Florida, United States, 33486

United Health Research, LLC

Miami, Florida, United States, 33144

United States, Georgia

Piedmont Heart Institute

Atlanta, Georgia, United States, 30309

IACT Health

Columbus, Georgia, United States, 31904

Piedmont Heart Institute- Fayetteville

Fayetteville, Georgia, United States, 30214

Piedmont Heart Institute-Fayetteville

Fayetteville, Georgia, United States, 30309

Georgia Arrythmia Consultants&Research Institute

Macon, Georgia, United States, 312012

United States, Idaho

St. Luke's Idaho Cardiology Associates

Boise, Idaho, United States, 83702

Idaho Catalyst Clinical Research

Idaho Falls, Idaho, United States, 83404

United States, Illinois

AMITA Health Medical Group Heart & Vascular Elk Grpve Village

Elk Grove Village, Illinois, United States, 60007

United States, Indiana

Parkview Physicians Group - Cardiology

Fort Wayne, Indiana, United States, 46845

United States, Louisiana

Clinical Trials of America, LLC - Monroe, LA

Monroe, Louisiana, United States, 71291

United States, Maryland

MedStar Health Research Institute - Chesapeake Cardiovascular Associates

Baltimore, Maryland, United States, 21237

United States, Michigan

Sparrow Clinical Research Institute

Lansing, Michigan, United States, 48912

Revival Research Institute, LLC - Southgate, MI

Southgate, Michigan, United States, 48195

United States, Missouri

Mercy Research

Saint Louis, Missouri, United States, 65804

United States, New Jersey

Cardiovascular Associates of the Delaware Valley - Elmer

Elmer, New Jersey, United States, 08318

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, United States, 08035

United States, New York

Montefiore Medical Center

Bronx, New York, United States, 10467

Columbia University

New York, New York, United States, 10032

Weill Cornell Medical Center

New York, New York, United States, 10065

United States, North Carolina

Cary Research Group, LLC

Cary, North Carolina, United States, 27518

Sanger Heart and Vascular Institute

Charlotte, North Carolina, United States, 28204

The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute

Charlotte, North Carolina, United States, 28204

United States, Ohio

The Ohio State University (OSU) Wexner Medical Center

Columbus, Ohio, United States, 43210

Rama Research LLC

Marion, Ohio, United States, 43302

ProMedica Toledo Hospital

Toledo, Ohio, United States, 43615

United States, South Carolina

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States, 29425

Prisma Health Midlands

Columbia, South Carolina, United States, 29203

United States, South Dakota

Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc

Rapid City, South Dakota, United States, 57701

United States, Texas

North Texas Research Associates

Allen, Texas, United States, 75013

Cardiovascular Clinic of North Texas

Denton, Texas, United States, 76201

Revival Research Institute, LLC

Denton, Texas, United States, 76201

Apex Trials Group

Fort Worth, Texas, United States, 76104

Angiocardiac Care of Texas

Houston, Texas, United States, 77025

Scott & White Memorial Hospital: Baylor Scott & White Research Institute

Temple, Texas, United States, 76508

Bay Area Heart

Webster, Texas, United States, 77598

United States, Utah

IHC Health Services Inc. DBA Intermountain Medical Center

Murray, Utah, United States, 84157-7000

Belgium

Clinique Du Sud- Luxembourg

Arlon, Belgium, 6700

Imelda Hospital

Bonheiden, Belgium, 2820

Universite Libre de Bruxelles (ULB) - Hopital Erasme

Bruxelles, Belgium, 1070

UVC Brugmann University Hospital - Centre Hospitalier Universitaire (CHU)

Bruxelles, Belgium, 1090

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Belgium, 2650

Jessa Ziekenhuis

Hasselt, Belgium, 3500

University Hospital (UZ) Leuven

Leuven, Belgium, 3000

Regional Hospital Centre Citadelle

Liège, Belgium, 4000

CHU Ambroise Pare

Mons, Belgium, 7000

CHU Mont-Godinne

Yvoir, Belgium, 5530

Canada, Alberta

Libin Cardiovascular Institute of Alberta - University of Calgary

Calgary, Alberta, Canada, T2N 4Z6

Canada, British Columbia

Medical Arts Health Research Group - North Vancouver

North Vancouver, British Columbia, Canada, V5Z 0A9

Victoria Cardiac Arrhythmia Trials, Inc.

Victoria, British Columbia, Canada, V8T 1Z4

Canada, Manitoba

University of Manitoba, St Boniface General Hospital

Winnipeg, Manitoba, Canada, R2H 2A6

Canada, Nova Scotia

Dalhousie University - QEII Health Sciences Centre

Halifax, Nova Scotia, Canada, B3H 3A7

Canada, Ontario

Cambridge Cardiac Care Centre

Cambridge, Ontario, Canada, N1R 6V6

Dawson Road Medical Centre

Guelph, Ontario, Canada, N1H 1B1

London Health Sciences Centre

London, Ontario, Canada, N6A 5A5

Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic

Newmarket, Ontario, Canada, M2R 3V6

St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Canada, Quebec

The Montreal Heart Institute

Montreal, Quebec, Canada, H1T 1C8

CHUM Hotel Dieu

Montreal, Quebec, Canada, H2W 1T8

McGill University Health Center - Research Institute

Montréal, Quebec, Canada, H3G 1A4

Institut Universitaire de Cardiologie et de Pneumologie De Quebec

Québec, Quebec, Canada, G1V 4G5

CardioVasc HR

Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1J2

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, Canada, J1H 5N4

CSSS du Sud de Lanaudiere - Hopital Pierre Le Gardeur

Terrebonne, Quebec, Canada, J6V 2H2

France

CHRU Besancon - Hopital Jean Minjoz

Besançon, Besancon, France, 25030

CHU Grenoble-Alpes - Hopital Michallon

La Tronche, Grenoble, France, 38043

CHRU de Brest - Hopital de la Cavale Blanche

Brest, France, 29609

HCL Hopital Louis Pradel

Bron, France, 69677

Hopital Saint-Louis de La Rochelle

La Rochelle, France, 17000

CHU de Lille - Institut Cœur Poumon

Lille, France, 59037

Centre Hospitalier de Pau

Pau, France, 64000

Germany

Maerkische Gesundheitsholding GmbH - Klinikum Luedenscheid

Lüdenscheid, Ludenscheid, Germany, 58515

Peter Osypka Herzzentrum Munchen

München, Munchen, Germany, 81379

Vivantes Klinikum Neukoelln

Berlin, Germany, 12351

FAZ Dresden-Neustadt GbR

Dresden, Germany, 01099

Kardiologische Praxis

Dresden, Germany, 04779

Kardiologische Gemeinschaftspraxis Papenburg

Papenburg, Germany, 26871

Zentrum fuer Praevention und Rehabilitation

Siegen, Germany, 57072

Hungary

Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo

Bekescsaba, Bekescaba, Hungary, 5600

Nehezlegzes Ambulancia

Debrecen, Debrecon, Hungary, 4026

Del-pesti Centrumkorhaz

Budapest, Hungary, 1097

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, Hungary, 1134

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Belvarosi Egeszseghaz

Zalaegerszeg, Hungary, 8900

Netherlands

Meander Medisch Centrum - Locatie Amersfoort

Amersfoort, Netherlands, 3816TE

Ziekenhuis Rijnstate - Locatie Arnhem

Arnhem, Netherlands, 6815 AD

Rode Kruis Ziekenhuis

Beverwijk, Netherlands, 1942

Tergooiziekenhuizen Blaricum

Blaricum, Netherlands, 1261 AN

Amphia Ziekenhuis - Locatie Breda Molengracht

Breda, Netherlands, 4818 CK

IJsselland ziekenhuis

Capelle Aan Den IJssel, Netherlands, 2906

Reinier de Graaf Gasthuis

Delft, Netherlands, 2625 AD

Jeroen Bosch Ziekenhuis

Den Bosch, Netherlands, 3584

Deventer Ziekenhuis

Deventer, Netherlands, 7416SE

Slingeland Ziekenhuis

Doetinchem, Netherlands, 7009

Ziekenhuis Gelderse Vallei

Ede, Netherlands, 6716

Ropcke-Zweers Ziekenhuis

Hardenberg, Netherlands, 7772 SE

Treant Zorggroep

Hoogeveen, Netherlands, 7909

Alrijne Ziekenhuis

Leiderdorp, Netherlands, 2353 GA

Maastricht University Medical Center

Maastricht, Netherlands, 6229 HX

Bravis ziekenhuis - Locatie Roosendaal

Roosendaal, Netherlands, 4708 AE

Franciscus Gasthuis & Vlietland - Locatie Vlietland

Schiedam, Netherlands, 3118

Diakonessenhuis - Locatie Utrecht

Utrecht, Netherlands, 3582

Poland

American Heart of Poland S.A., IV Oddzial Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii

Kędzierzyn-Koźle, Kedzierzyn Kozle, Poland, 43-450

Gabinety Daszmed

Kraków, Krakov, Poland, 31-534

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi

Łódź, Lodz, Poland, 92-213

Instytut Centrum Zdrowia Matki Polki

Łódź, Lodz, Poland, 93-338

Specjalistyczna Praktyka Lekarska

Ruda Śląska, Ruda Slaska, Poland, 40-530

Kliniczny Szpital Wojewódzki nr 2, Rzeszów

Rzeszów, Rzeszow, Poland, 35-301

MICS Centrum Medyczne

Bydgoszcz, Poland, 85-065

Centrum Medyczne KERmed

Bydgoszcz, Poland, 85-231

Prywatny Specjalistyczny Gabinet Internistyczny

Libiąż, Poland, 32-590

MEDICOME Sp. z o.o.

Oswiecim, Poland, 32-600

SP ZOZ Szpital Specjalistyczny w Pulawach

Puławy, Poland, 24-100

NZOZ Pro Cordis Sopockie Centrum Badan Kardiologicznych

Sopot, Poland, 81-717

Osrodek Badan Klinicznych CLINSANTE S.C.

Toruń, Poland, 87-100

X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji

Tychy, Poland, 43-100

Kardiosystem

Warsaw, Poland, 04-628

Spain

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain, 08916

Hospital Universitario Reina Sofia

Córdoba, Cordoba, Spain, 14004

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, Spain, 29010

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain, 36213

Generalitat Valenciana Conselleria De Sanitat

Alicante, Spain, 03010

Hospital Universitari de Bellvitge

Barcelona, Spain, 08907

Hospital Universitario Vall d'Hebron

Barcelona, Spain, 119-129

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 8025

Martínez Hervás Cardiólogos

Granada, Spain, 18002

Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves

Granada, Spain, 18014

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28007

Hospital Universitario La Paz

Madrid, Spain, 28046

Hospital Universitario Puerta de Hierro

Majadahonda, Spain, 28222

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, Spain, 30120

Hospital Universitario Central de Asturias

Oviedo, Spain, 33011

Complejo Hospitalario de Navarra

Pamplona, Spain, 31008

Hospital Universitari Sant Joan de Reus

Reus, Spain, 43204

Hospital Clinico Universitario de Santiago

Santiago De Compostela, Spain, 15706

Hospital Universitario Virgen Macarena

Sevilla, Spain, 41009

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Hospital Clinico Universitario de Valencia

Valencia, Spain, 46010

Consorcio Hospital General Universitario de Valencia

Valencia, Spain, 46014

Hospital Universitario Clínico Lozano Blesa

Zaragoza, Spain, 50009

Sponsors and Collaborators

Milestone Pharmaceuticals Inc.

Medpace, Inc.

IQVIA Biotech

Investigators

• Study Director: Francis Plat, MD; Milestone Pharmaceuticals

More Information

• Responsible Party: Milestone Pharmaceuticals Inc.
• ClinicalTrials.gov Identifier: NCT03464019
• Other Study ID Numbers: MSP-2017-1138
• First Posted: March 13, 2018
• Last Update Posted: February 14, 2023
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Milestone Pharmaceuticals Inc.:

Paroxysmal supraventricular tachycardia; cardiac monitoring; atrioventricular nodal reentrant tachycardia; atrioventricular reciprocating tachycardia; calcium channel blocker; conversion rate

Additional relevant MeSH terms:

Etripamil; Tachycardia; Tachycardia, Supraventricular; Tachycardia, Ventricular; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs