Study Stopped
The closure of the event-driven study was terminated due to the total sample size was reached.
Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT).
NODE-301
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 and RAPID Studies
2 other identifiers
interventional
1,097
9 countries
161
Brief Summary
This was a three-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by participants who experienced an episode of paroxysmal supraventricular tachycardia (PSVT) in an at-home setting. NODE-301 Part 1 included participants that received the randomized study drug to treat an episode of PSVT until the 150th positively adjudicated PSVT episode. Part 2 (also referred as the RAPID study) included participants that did not receive the randomized study drug in Part 1 and newly enrolled participants until the 180th positively adjudicated PSVT episode in Part 2. The study continued for approximately 6 months after the 180th positively adjudicated PSVT episode in Part 2 and this extension is referred to as Part 3 (also referred to as RAPID Extension).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2018
Longer than P75 for phase_3
161 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2018
CompletedFirst Posted
Study publicly available on registry
March 13, 2018
CompletedStudy Start
First participant enrolled
June 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2023
CompletedResults Posted
Study results publicly available
July 12, 2024
CompletedJuly 12, 2024
May 1, 2024
4.6 years
March 7, 2018
February 16, 2024
June 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 5 hours (NODE-301 Part 1), or 30 minutes (NODE-301 Parts 2 and 3) of start of study drug dosing.
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.
Study Arms (6)
Part 1: Etripamil 70 mg Single Dose
EXPERIMENTALSelf-administration of a single dose etripamil 70 mg for a perceived episode of PSVT.
Part 1: Placebo Single Dose
PLACEBO COMPARATORSelf-administration of a single dose of placebo for a perceived episode of PSVT.
Part 1: Test dose only (etripamil 70 mg)
OTHERSingle test dose of etripamil 70 mg in sinus rhythm
Part 2 & Part 3: Etripamil 70 mg with Optional Second Dose
EXPERIMENTALSelf-administration of 70 mg etripamil for a perceived episode of PSVT followed 10 minutes later by an optional second dose of 70 mg etripamil, if symptoms persisted. Participants could be enrolled in the open-label period to treat an additional PSVT episode with etripamil.
Part 2 & Part 3: Placebo with Optional Second Dose
PLACEBO COMPARATORSelf-administration of placebo for a perceived episode of PSVT followed 10 minutes later by an optional second dose of placebo, if symptoms persisted. Participants could be enrolled in the open-label period to treat an additional PSVT episode with etripamil.
Part 2 & Part 3: Test dose only (etripamil 70 mg + 70 mg)
OTHERRepeat Test Dose of etripamil 70 mg (2X 70mg) 10 minutes apart in sinus rhythm
Interventions
Etripamil 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 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.
During the Test Dose, etripamil 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.
Eligibility Criteria
You may qualify if:
- Participants who met all of the following criteria were eligible to participate in the study:
- Male or female participants at least 18 years of age;
- Electrographically documented history of PSVT (e.g., electrocardiogram \[ECG\] obtained during an episode of PSVT, Holter monitoring, loop recorder, etc). If participant had a prior ablation for PSVT, participant had to have documented ECG evidence of PSVT post-ablation;
- History of sustained episodes of PSVT (i.e., typically lasting approximately 20 minutes or longer);
- Females of childbearing potential who were sexually active with a male partner who were not surgically sterile (i.e., vasectomy) had to 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 had to 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 had to use a highly effective form of contraception between the visits.
- The following categories defined females who were NOT considered to be of childbearing potential:
- Premenopausal females with 1 of the following:
- Documented hysterectomy,
- Documented bilateral salpingectomy or tubal ligation; or
- Documented bilateral oophorectomy, or
- Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause;
- Male participants, except those who were surgically sterile, had to use an approved highly effective form of contraception during the 3 days after any study drug administration; and
- Signed written informed consent.
You may not qualify if:
- Participants who met any of the following criteria were excluded from participation in the study:
- Systolic blood pressure \<90 mmHg after a 5-minute rest in sitting position at the Screening Visit or before the Test Dose. In participants treated with a chronic prophylactic drug for PSVT (e.g., beta-blockers, verapamil, and diltiazem), the drug could be stopped for at least the equivalent of 5 half-lives, participants could be rescreened once, and chronic use of the drug could not be restarted after randomization;
- History of severe symptoms of hypotension, especially syncope, during episodes of PSVT;
- History of atrial arrhythmia that did not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, intra-atrial tachycardia);
- History of allergic reaction to verapamil;
- Current therapy with digoxin or any Class I or III antiarrhythmic drug, except if these drugs were stopped at least the equivalent of 5 half-lives before the Test Dose Randomization Visit;
- Current chronic therapy with oral amiodarone, or had taken oral amiodarone within 30 days prior to the Test Dose Randomization Visit;
- 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;
- Evidence of a second- or third-degree AV block on the ECG performed at the Screening Visit or before the Test Dose administration;
- History or evidence of severe ventricular arrhythmia (e.g., torsades de pointes, ventricular fibrillation, or ventricular tachycardia);
- Current congestive heart failure defined by the New York Heart Association Class II to IV;
- History of Acute Coronary Syndrome or stroke within 6 months of screening;
- 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;
- 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;
- Females who were pregnant or lactating;
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Milestone Pharmaceuticals Inc.lead
- Medpace, Inc.collaborator
- IQVIA Biotechcollaborator
Study Sites (161)
Arizona Arrhythmia Research Center
Phoenix, Arizona, 85016, United States
Arkansas Cardiology
Little Rock, Arkansas, 72205, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Medvin Clinical Research
Cerritos, California, 91722, United States
North Coast Cardiolog
Encinitas, California, 92024, United States
Titan Medical Research - Oceanside
Encinitas, California, 92024, United States
Los Alamitos Cardiovascular
Los Alamitos, California, 90720, United States
Amicis Research Center - Northridge
Northridge, California, 91324, United States
RESPIRE Research
Palm Springs, California, 92262, United States
South Denver Cardiology Associates, P.C
Littleton, Colorado, 80120, United States
Cardiology Associates of Fairfield County
Norwalk, Connecticut, 06905, United States
FWD Clinical Research
Boca Raton, Florida, 33486, United States
Baptist Health Ambulatory Services d/b/a
Jacksonville, Florida, 32207, United States
United Health Research, LLC
Miami, Florida, 33144, United States
IACT Health
Columbus, Georgia, 31904, United States
Piedmont Heart Institute- Fayetteville
Fayetteville, Georgia, 30214, United States
Piedmont Heart Institute-Fayetteville
Fayetteville, Georgia, 30309, United States
Georgia Arrythmia Consultants&Research Institute
Macon, Georgia, 31201, United States
St. Luke's Idaho Cardiology Associates
Boise, Idaho, 83702, United States
Idaho Catalyst Clinical Research
Idaho Falls, Idaho, 83404, United States
AMITA Health Medical Group Heart & Vascular Elk Grpve Village
Elk Grove Village, Illinois, 60007, United States
Parkview Physicians Group - Cardiology
Fort Wayne, Indiana, 46845, United States
Mercy One Iowa Heart Center
West Des Moines, Iowa, 50266, United States
Clinical Trials of America, LLC - Monroe, LA
West Monroe, Louisiana, 71291, United States
MedStar Health Research Institute - Chesapeake Cardiovascular Associates
Baltimore, Maryland, 21237, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Revival Research Institute, LLC - Southgate, MI
Southgate, Michigan, 48195, United States
Mercy Research
St Louis, Missouri, 65804, United States
Cardiovascular Associates of the Delaware Valley - Elmer
Elmer, New Jersey, 08318, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035, United States
Atlantic Health System - Morristown Medical Center
Morristown, New Jersey, 07962, United States
Columbia University
New York, New York, 10032, United States
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Cary Research Group, LLC
Cary, North Carolina, 27518, United States
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204, United States
The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204, United States
Hatton Institute for Research & Education, Trihealth, Inc. - Cardiology
Cincinnati, Ohio, 45242, United States
The Ohio State University (OSU) Wexner Medical Center
Columbus, Ohio, 43210, United States
Rama Research LLC
Marion, Ohio, 43302, United States
Heart House Research Foundation, LLC
Springfield, Ohio, 45505, United States
ProMedica Toledo Hospital
Toledo, Ohio, 43615, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Prisma Health Midlands
Columbia, South Carolina, 29203, United States
Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc
Rapid City, South Dakota, 57701, United States
North Texas Research Associates
Allen, Texas, 75013, United States
Cardiovascular Clinic of North Texas
Denton, Texas, 76201, United States
Revival Research Institute, LLC
Denton, Texas, 76201, United States
Apex Trials Group
Fort Worth, Texas, 76104, United States
Angiocardiac Care of Texas
Houston, Texas, 77025, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Scott & White Memorial Hospital: Baylor Scott & White Research Institute
Temple, Texas, 76508, United States
Bay Area Heart
Webster, Texas, 77598, United States
Intermountain Medical Center
Murray, Utah, 84157-7000, United States
Clinique Du Sud- Luxembourg
Arlon, 6700, Belgium
Imelda Hospital
Bonheiden, 2820, Belgium
UVC Brugmann University Hospital - Centre Hospitalier Universitaire (CHU)
Brussels, 1020, Belgium
Universite Libre de Bruxelles (ULB) - Hopital Erasme
Brussels, 1070, Belgium
Antwerp University Hospital (UZA)
Edegem, 2650, Belgium
Grand Hopital de Charleroi (GHdC) - Site Saint-Joseph
Gilly, 6060, Belgium
Pharmacy Campus Virga Jesse (losplaats 7)
Hasselt, 3500, Belgium
University Hospital (UZ) Leuven
Leuven, 3000, Belgium
Regional Hospital Centre Citadelle
Liège, 3000, Belgium
CHU Ambroise Pare
Mons, 7000, Belgium
CHU UCL Namur - Site Godinne
Yvoir, 5530, Belgium
Libin Cardiovascular Institute of Alberta - University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
Medical Arts Health Research Group - North Vancouver
North Vancouver, British Columbia, V5Z 0A9, Canada
Vancouver Coastal Health Research
Vancouver, British Columbia, V5Z 1M9, Canada
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria, British Columbia, V8T 1Z4, Canada
University of Manitoba, St Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Dalhousie University - QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6, Canada
Dawson Road Medical Centre
Guelph, Ontario, N1H 1B1, Canada
Hamilton Health Sciences
Hamilton, Ontario, L8L 0A6, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic
Newmarket, Ontario, L3Y 2P6, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
The Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
CHUM Recherche Cardiologie
Montreal, Quebec, H2X 0A9, Canada
McGill University Health Center - Research Institute
Montreal, Quebec, H3G 1A4, Canada
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Québec, Quebec, G1V 4G5, Canada
CardioVasc HR
Saint-Jean-sur-Richelieu, Quebec, J3A 1J2, Canada
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, J1H 5N4, Canada
CSSS du Sud de Lanaudiere - Hopital Pierre Le Gardeur
Terrebonne, Quebec, J6V 2H2, Canada
CHRU Besancon - Hopital Jean Minjoz
Besançon, Besancon, 25030, France
CHU Grenoble-Alpes - Hopital Michallon
La Tronche, Grenoble, 38043, France
CHRU de Brest - Hopital de la Cavale Blanche
Brest, 29609, France
HCL Hopital Louis Pradel
Bron, 69677, France
Hopital Saint-Louis de La Rochelle
La Rochelle, 17000, France
CHU de Lille - Institut Cœur Poumon
Lille, 59037, France
Centre Hospitalier de Pau
Pau, 64000, France
Maerkische Gesundheitsholding GmbH - Klinikum Luedenscheid
Lüdenscheid, Ludenscheid, 58515, Germany
Peter Osypka Herzzentrum Munchen
München, Munchen, 81379, Germany
Vivantes Klinikum Neukoelln
Berlin, 12351, Germany
FAZ Dresden-Neustadt GbR
Dresden, 01099, Germany
Kardiologische Praxis
Dresden, 04779, Germany
Kardiologische Gemeinschaftspraxis Papenburg
Papenburg, 26871, Germany
Zentrum fuer Praevention und Rehabilitation
Siegen, 57072, Germany
Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo
Békéscsaba, Bekescaba, 5600, Hungary
Nehezlegzes Ambulancia
Debrecen, Debrecon, 4026, Hungary
Del-pesti Centrumkorhaz
Budapest, 1097, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1134, Hungary
Debreceni Egyetem Klinikai
Debrecen, 4032, Hungary
CRU Hungary Kft.
Encs, H-3860, Hungary
Belvarosi Egeszseghaz
Zalaegerszeg, 8900, Hungary
Meander Medisch Centrum - Locatie Amersfoort
Amersfoort, 3813 TZ, Netherlands
Ziekenhuis Rijnstate - Locatie Arnhem
Arnhem, 6815 AD, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, 1942 LE, Netherlands
Tergooiziekenhuizen Blaricum
Blaricum, 1261 AN, Netherlands
Amphia Ziekenhuis - Locatie Breda Molengracht
Breda, 4818 CK, Netherlands
IJsselland ziekenhuis
Capelle aan den IJssel, 2906 ZC, Netherlands
Reinier de Graaf Gasthuis
Delft, 2625 AD, Netherlands
Deventer Ziekenhuis
Deventer, 7416 SE, Netherlands
Slingeland Ziekenhuis
Doetinchem, 7009 BL, Netherlands
Ziekenhuis Gelderse Vallei
Ede, 6716 RP, Netherlands
Ropcke-Zweers Ziekenhuis
Hardenberg, 7772 SE, Netherlands
Treant Zorggroep
Hoogeveen, 7909, Netherlands
Alrijne Ziekenhuis
Leiderdorp, 2353 GA, Netherlands
Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
Franciscus Gasthuis & Vlietland - Locatie Vlietland
Schiedam, 3118 JH, Netherlands
Diakonessenhuis - Locatie Utrecht
Utrecht, 3582 KE, Netherlands
Jeroen Bosch Ziekenhuis
Utrecht, 3584 CX, Netherlands
American Heart of Poland S.A., IV Oddzial Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii
Kędzierzyn-Koźle, Kedzierzyn Kozle, 43-450, Poland
Gabinety Daszmed
Krakow, Krakov, 31-534, Poland
Kliniczny Szpital Wojewódzki nr 2, Rzeszów
Rzeszów, Rzeszow, 35-301, Poland
MICS Centrum Medyczne Torun
Bydgoszcz, 85-065, Poland
Centrum Medyczne Kermed
Bydgoszcz, 85-231, Poland
Specjalistyczna Praktyka Lekarska
Katowice, 40-530, Poland
Prywatny Specjalistyczny Gabinet Internistyczny
Libiąż, 32-590, Poland
MEDICOME Sp. z o.o.
Oświęcim, 32-600, Poland
SP ZOZ Szpital Specjalistyczny w Pulawach
Puławy, 24-100, Poland
NZOZ Pro Cordis Sopockie Centrum Badan Kardiologicznych
Sopot, 81-717, Poland
Osrodek Badan Klinicznych CLINSANTE S.C.
Torun, 87-100, Poland
X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji
Tychy, 43-100, Poland
Kardiosystem
Warsaw, 04-628, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi
Lodz, Łódź Voivodeship, 92-213, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, 93-338, Poland
Martínez Hervás Cardiólogos
Granada, Andalusia, 18002, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitario Reina Sofia
Córdoba, Cordoba, 14004, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Malaga, 29010, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, 36213, Spain
Hospital General Universitario de Valencia (HGUV)
Valencia, Valencia, 46014, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitari de Bellvitge
Barcelona, 08907, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 8025, Spain
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, 28222, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Complejo Hospitalario de Navarra
Pamplona, 31008, Spain
Hospital Universitari Sant Joan de Reus
Reus, 43204, Spain
Hospital Universitario la Paz Rua Choupana
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitario Clínico Lozano Blesa
Zaragoza, 50009, Spain
Related Publications (3)
Stambler BS, Camm AJ, Alings M, Dorian P, Heidbuchel H, Houtgraaf J, Kowey PR, Merino JL, Mondesert B, Piccini JP, Pokorney SD, Sager PT, Verma A, Wharton JM, Bharucha DB, Plat F, Shardonofsky S, Chen M, Ip JE; RAPID Investigators. Self-administered intranasal etripamil using a symptom-prompted, repeat-dose regimen for atrioventricular-nodal-dependent supraventricular tachycardia (RAPID): a multicentre, randomised trial. Lancet. 2023 Jul 8;402(10396):118-128. doi: 10.1016/S0140-6736(23)00776-6. Epub 2023 Jun 15.
PMID: 37331368DERIVEDStambler BS, Plat F, Sager PT, Shardonofsky S, Wight D, Potvin D, Pandey AS, Ip JE, Coutu B, Mondesert B, Sterns LD, Bennett M, Anderson JL, Damle R, Haberman R, Camm AJ. First Randomized, Multicenter, Placebo-Controlled Study of Self-Administered Intranasal Etripamil for Acute Conversion of Spontaneous Paroxysmal Supraventricular Tachycardia (NODE-301). Circ Arrhythm Electrophysiol. 2022 Dec;15(12):e010915. doi: 10.1161/CIRCEP.122.010915. Epub 2022 Nov 28.
PMID: 36441560DERIVEDStambler BS, Plat F, Sager PT, Lubkov V, Shardonofsky S, Wight D, Chen M, Camm AJ. Rationale for and design of a multicenter, placebo-controlled, phase 3 study to assess efficacy and safety of intranasal etripamil for the conversion of paroxysmal supraventricular tachycardia. Am Heart J. 2022 Nov;253:20-29. doi: 10.1016/j.ahj.2022.06.005. Epub 2022 Jun 18.
PMID: 35728658DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cameron Szakacs_PhD_VP Drug Development
- Organization
- Milestone Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
David Bharucha, MD
Milestone Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants, care providers, investigators, and outcomes assessor were blinded to the treatment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2018
First Posted
March 13, 2018
Study Start
June 18, 2018
Primary Completion
January 20, 2023
Study Completion
January 20, 2023
Last Updated
July 12, 2024
Results First Posted
July 12, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share