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A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension (SALTO)

Primary Purpose

Hypertension, Pulmonary

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Selexipag
Placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants between greater than or equal to (>=) 2 and less than (<) 18 years of age weighing >=9 kilogram (kg) at randomization
  • Pulmonary arterial hypertension (PAH) diagnosis confirmed by documented historical right heart catheterization (RHC) performed at any time before participant's screening
  • PAH (World Health Organization [WHO] Group 1), including participants with Down syndrome, of the following etiologies: Idiopathic PAH (IPAH); Heritable PAH (HPAH); PAH associated with congenital heart disease (PAH-associated with congenital heart disease [aCHD]) (PAH with coincidental CHD [that is, a small atrial septal defect, ventricular septal defect, or patent ductus arteriosus that does not itself account for the development of elevated PVR] and if approved by the BCAC) and Post-operative PAH (persisting / recurring/ developing >=6 months after repair of CHD); Drug or toxin-induced; PAH associated with Human immunodeficiency virus (HIV)
  • WHO functional class (FC) II and III
  • Participants treated with at least 1 PAH-specific treatment, example, an Endothelin receptor antagonist (ERA) and/or a Phosphodiesterase type-5 (PDE-5) inhibitor/soluble guanylate cyclase stimulator, provided that the treatment dose(s) has been stable for at least 3 months prior to first dose of study intervention

Exclusion Criteria:

  • PAH due to portal hypertension, schistosomiasis, pulmonary veno-occlusive disease, and/or pulmonary capillary hemangiomatosis
  • PAH associated with Eisenmenger syndrome
  • Previous exposure to Uptravi (selexipag)
  • Known concomitant life-threatening disease with a life expectancy <12 months
  • Pregnant, planning to become pregnant, or lactating
  • Known allergies, hypersensitivity, or intolerance to selexipag or its excipients

Sites / Locations

  • Phoenix Children's Hospital
  • UCLA Medical Center
  • UCSF
  • Childrens Hospital Colorado
  • Children's National Medical Center
  • Congenital Heart Center of the University of Florida
  • Riley Hospital for Children
  • Detroit Medical Center
  • Cincinnati Children's Hospital Medical Center
  • Childrens Hospital Of Philadelphia
  • Texas Children's Hospital
  • Primary Children's Hospital
  • University of Virginia Division of Pediatric Cardiology
  • Queensland CHILDREN'S HOSPITAL
  • State Institution Republican Scientific And Practical Center For Pediatric Surgery
  • Health Institution 4Th City Children'S Clinical Hospital
  • ULB Hôpital Erasme
  • Universitair Ziekenhuis Gent
  • Universitaire Ziekenhuizen Leuven
  • Complexo de Prevencao,Diagnostico,Terapia e Reabilitacao Respiratoria LTDA Hospital Dia do Pulmao
  • Fundacao Universitaria de Cardiologia - Instituto de Cardiologia e Transplantes do DF
  • Hospital Pequeno Principe
  • Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
  • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Fundacao Universitaria de Cardiologia
  • Irmandade Santa Casa de Misericordia de Sao Paulo
  • SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
  • Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead
  • Stollery Children's Hospital
  • Hospital For Sick Children
  • Beijing Anzhen Hospital
  • Guangzhou Women And Children's Medical Center
  • Qingdao Women and Children's Hospital
  • Shanghai Children's Medical Center
  • Children's Hospital of Fudan University
  • The General Hospital of Northern Theater Command
  • Clinica San Rafael
  • Fundacion Neumologica Colombiana
  • Fundacion Santa Fe de Bogota
  • Clínica Imbanaco S.A.S.
  • Fundacion Cardiovascular de Colombia
  • Hospital Universidad del Norte
  • New Children's Hospital of the Helsinki University Hospital (HUS)
  • Hôpital Cardiologique - Chru Lille
  • Hopital de la Timone
  • CHU Arnaud de Villeneuve
  • Hôpital Necker - Enfants Malades
  • Hôpital Cardiologique Du Haut-Lévêque
  • Chu Hopital Des Enfants
  • Universitätsklinikum Freiburg Zentrum
  • Universitaetsklinikum Heidelberg
  • Herzzentrum Leipzig GmbH
  • Klinikum der Universitaet Muenchen
  • Gottsegen György Országos Kardiológiai Intézet
  • Our Lady's Children's Hospital
  • Rambam Medical Center
  • Sheba Medical Center
  • Azienda Ospedaliera Policlinico S. Orsola-Malpighi
  • ASST Grande Ospedale Metropolitano Niguarda
  • Universtà Degli Studi Di Padova
  • Ospedale Pediatrico Bambin Gesù
  • IRCCS Policlinico San Donato
  • AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita
  • Pusan National University Yangsan Hospital
  • Seoul National University Hospital
  • Samsung Medical Center
  • Severance Hospital, Yonsei University Health System
  • Vilnius University Hospital Santariskiu Clinics
  • National Heart Institute
  • CICUM San Miguel
  • Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas
  • Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
  • Uniwersyteckie Centrum Kliniczne
  • Uniwersytecki Szpital Dzieciecy w Krakowie
  • Szpital Kliniczny im. Karola Jonschera
  • Instytut Pomnik - Centrum Zdrowia Dziecka
  • Wojewodzki Szpital Specjalistyczny we Wroclawiu
  • Slaskie Centrum Chorob Serca
  • Hospital De Santa Marta
  • Centro Hospitalar de São João, EPE
  • Kazan State Medical University
  • Kazan State Medical University
  • Cardiovascular Pathology Research Institute of Siberian Branch of RAMS
  • Childrens City Clinical Hospital n.a. Bashlyaeva
  • Veltischev Research and Clinical Institute for Pediatrics of the Pirogov RNRMU
  • Samara Regional Clinical Cardiological Dispensary
  • Univerzitetska Dečja Klinika
  • Hosp. Univ. A Coruña
  • Hosp. Univ. Vall D Hebron
  • Hosp. Sant Joan de Deu
  • Hosp. Gral. Univ. Gregorio Maranon
  • Hosp. Univ. La Paz
  • Hosp. Virgen Del Rocio
  • Drottning Silvias barn- och ungdomssjukhus
  • Skanes universitetssjukhus
  • Centre Hospitalier Universitaire Vaudois (CHUV)
  • Kaohsiung Veterans General Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Chiang Mai University Hospital
  • Songklanagarind hospital
  • Cukurova Balcali Hospital Application and Research Center
  • Hacettepe University Medical Faculty
  • CAPA Istanbul University Medical Faculty
  • Mehmet Akif Ersoy Training and Research Hospital
  • Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital
  • Izmir Tepecik Training and Research Hospital
  • Dnipropetrovsk clinical medical center of Mother and Child after prof. Rudnev
  • MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'
  • Scientific Practical Medical Center for Pediatric Cardiology and Cardio Surgery of the MOH
  • MI Zaporizhzhia Regional Clinical Childrens Hospital of Zaporizhzhia Regional Council
  • Hanoi Medical University Hospital
  • Tam Anh Hospital
  • University Medical Center Ho Chi Minh city
  • Children's Hospital 1

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Selexipag

Placebo

Arm Description

Participants will receive selexipag based on the body weight on Day 1 and will continue thereafter with twice daily dosing. Selexipag will be uptitrated during the first 12 weeks until the participants reaches the individual maximum tolerated dose (iMTD) or until a maximum dose corresponding to their baseline body-weight category is achieved. Uptitration is followed by a maintenance period after Week 12 until end of treatment (EOT), at the maximum tolerated dose.

Participants will receive matching placebo based on the body weight on Day 1 and will continue thereafter with twice daily dosing.

Outcomes

Primary Outcome Measures

Time to Disease Progression
Time to disease progression is the time from randomization up to 7 days after study treatment discontinuation. Disease progression is defined as the first occurrence of either of the following components: Death (all causes), Atrial septostomy or Potts' anastomosis, or registration on lung transplant list, Hospitalization due to worsening pulmonary arterial hypertension (PAH), Clinical worsening of PAH.

Secondary Outcome Measures

Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious AEs
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are AEs with onset during the intervention period or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants with AEs Leading to Premature Discontinuation of Study Treatment
Percentage of participants with AEs leading to premature discontinuation of study treatment will be reported.
Change from Baseline in Systolic and Diastolic Arterial Blood Pressure
Change from baseline in systolic and diastolic arterial blood pressure to all assessed time points will be reported.
Change from Baseline in Pulse Rate
Change from baseline in pulse rate to all assessed time points will be reported.
Change from Baseline in Body Weight
Change from baseline in body weight to all assessed time points will be reported.
Change from Baseline in Height
Change from baseline in height to all assessed time points will be reported.
Sexual Maturation (Tanner Stage) Change from Baseline to all Assessed Time Points
The sexual maturation change as per Tanner stage will be assessed from baseline to all assessed time points. Tanner stage I is defined as no pubic hair at all (prepubertal Dominic state); stage II is defined as a small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females); stage III is defined as when the hair becomes more coarse and curly, and begins to extend laterally; stage IV is defined as adult-like hair quality, extending across pubis but sparing medial thighs; and stage V is defined as when the: hair extends to medial surface of the thighs.
Percentage of Participants with Treatment-emergent Electrocardiogram Abnormalities
Percentage of participants with treatment-emergent electrocardiogram abnormalities will be reported.
Percentage of Participants with Treatment-emergent Marked Laboratory Abnormalities
Percentage of participants with treatment-emergent marked laboratory (serum chemistry [including pregnancy testing and thyroid markers] and hematology) abnormalities will be reported.
Treatment-emergent Change from Baseline in Thyroid Stimulating Hormone
Treatment-emergent change from baseline in thyroid stimulating hormone over time will be reported.
Time to First Clinical Event Committee (CEC)-confirmed Hospitalization or Death for PAH
Time to first CEC-confirmed hospitalization or death for PAH is the time (days) from randomization to first occurrence of CEC-confirmed hospitalization for PAH or death due to PAH up to 7 days after study intervention discontinuation.
Trough Plasma Concentration at Steady-state (Ctrough,ss) of Selexipag and its Metabolite ACT-333679
Ctrough,ss is defined as the plasma concentration just prior to the morning dose, with the last study intervention administration one day prior to the pharmacokinetic sampling and will be reported for Selexipag and its metabolite ACT-333679.
Change from Baseline at Week 24 in Log2 N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
The change from baseline at week 24 in log2 NT-proBNP will be reported.

Full Information

First Posted
November 8, 2019
Last Updated
October 10, 2023
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT04175600
Brief Title
A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension
Acronym
SALTO
Official Title
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged >=2 to <18 Years With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
December 9, 2024 (Anticipated)
Study Completion Date
January 10, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.
Detailed Description
Pediatric PAH is a rare and progressive disorder associated with considerable morbidity and mortality. Given the significant medical need to develop treatments in children with PAH, further clinical studies in the pediatric population are therefore needed to provide more data for the management of PAH in children. Selexipag (JNJ-67896049) is an orally available, selective, and long-acting non-prostanoid agonist of the prostacyclin receptor approved and commercially available for the treatment of adult participants with PAH. Selexipag and its metabolite possess anti-fibrotic, anti-proliferative, and anti-thrombotic properties. Currently, no medicines targeting prostacyclin pathway are approved for pediatric use in PAH. An effective and orally available therapy acting on the prostacyclin receptor such as selexipag introduced at medically appropriate stage of PAH disease, and primarily in combination with current first-line oral PAH-specific medicines in participants in need of additional therapy because of insufficient disease control would represents a major advance to the therapeutic management of PAH pediatric participants. This study consists of a screening period of up to 6 weeks and a double-blind treatment period, including up-titration and maintenance periods, followed by a 3-year open-label extension period (OLEP) and a 30-day safety follow-up period that occurs after the last dose of study intervention (either double-blind or open-label). Safety, pharmacokinetic and efficacy assessments will be performed during the study. An Independent Data Monitoring Committee (IDMC) will be established to monitor data on an ongoing basis, to review interim data, and to ensure the continuing safety of the participants enrolled in this study. The approximate duration of the study is 8 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selexipag
Arm Type
Experimental
Arm Description
Participants will receive selexipag based on the body weight on Day 1 and will continue thereafter with twice daily dosing. Selexipag will be uptitrated during the first 12 weeks until the participants reaches the individual maximum tolerated dose (iMTD) or until a maximum dose corresponding to their baseline body-weight category is achieved. Uptitration is followed by a maintenance period after Week 12 until end of treatment (EOT), at the maximum tolerated dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo based on the body weight on Day 1 and will continue thereafter with twice daily dosing.
Intervention Type
Drug
Intervention Name(s)
Selexipag
Other Intervention Name(s)
JNJ-67896049
Intervention Description
Selexipag tablet will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets will be administered orally.
Primary Outcome Measure Information:
Title
Time to Disease Progression
Description
Time to disease progression is the time from randomization up to 7 days after study treatment discontinuation. Disease progression is defined as the first occurrence of either of the following components: Death (all causes), Atrial septostomy or Potts' anastomosis, or registration on lung transplant list, Hospitalization due to worsening pulmonary arterial hypertension (PAH), Clinical worsening of PAH.
Time Frame
From randomization up to 7 days after study treatment discontinuation (up to 5 years)
Secondary Outcome Measure Information:
Title
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious AEs
Description
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are AEs with onset during the intervention period or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame
Up to 5 years
Title
Percentage of Participants with AEs Leading to Premature Discontinuation of Study Treatment
Description
Percentage of participants with AEs leading to premature discontinuation of study treatment will be reported.
Time Frame
Up to 5 years
Title
Change from Baseline in Systolic and Diastolic Arterial Blood Pressure
Description
Change from baseline in systolic and diastolic arterial blood pressure to all assessed time points will be reported.
Time Frame
Baseline up to end of treatment (EOT) (up to 8 years)
Title
Change from Baseline in Pulse Rate
Description
Change from baseline in pulse rate to all assessed time points will be reported.
Time Frame
Baseline up to EOT (up to 8 years)
Title
Change from Baseline in Body Weight
Description
Change from baseline in body weight to all assessed time points will be reported.
Time Frame
Baseline up to EOT (up to 8 years)
Title
Change from Baseline in Height
Description
Change from baseline in height to all assessed time points will be reported.
Time Frame
Baseline up to EOT (up to 8 years)
Title
Sexual Maturation (Tanner Stage) Change from Baseline to all Assessed Time Points
Description
The sexual maturation change as per Tanner stage will be assessed from baseline to all assessed time points. Tanner stage I is defined as no pubic hair at all (prepubertal Dominic state); stage II is defined as a small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females); stage III is defined as when the hair becomes more coarse and curly, and begins to extend laterally; stage IV is defined as adult-like hair quality, extending across pubis but sparing medial thighs; and stage V is defined as when the: hair extends to medial surface of the thighs.
Time Frame
Up to 3 days after study treatment discontinuation (up to EOT) (multiple timepoints up to 8 years)
Title
Percentage of Participants with Treatment-emergent Electrocardiogram Abnormalities
Description
Percentage of participants with treatment-emergent electrocardiogram abnormalities will be reported.
Time Frame
Baseline up to EOT (up to 8 years)
Title
Percentage of Participants with Treatment-emergent Marked Laboratory Abnormalities
Description
Percentage of participants with treatment-emergent marked laboratory (serum chemistry [including pregnancy testing and thyroid markers] and hematology) abnormalities will be reported.
Time Frame
Baseline up to EOT (up to 8 years)
Title
Treatment-emergent Change from Baseline in Thyroid Stimulating Hormone
Description
Treatment-emergent change from baseline in thyroid stimulating hormone over time will be reported.
Time Frame
Baseline up to EOT (up to 8 years)
Title
Time to First Clinical Event Committee (CEC)-confirmed Hospitalization or Death for PAH
Description
Time to first CEC-confirmed hospitalization or death for PAH is the time (days) from randomization to first occurrence of CEC-confirmed hospitalization for PAH or death due to PAH up to 7 days after study intervention discontinuation.
Time Frame
Until 7 days after study treatment discontinuation (Up to 8 years)
Title
Trough Plasma Concentration at Steady-state (Ctrough,ss) of Selexipag and its Metabolite ACT-333679
Description
Ctrough,ss is defined as the plasma concentration just prior to the morning dose, with the last study intervention administration one day prior to the pharmacokinetic sampling and will be reported for Selexipag and its metabolite ACT-333679.
Time Frame
Weeks 16, 24 and every 12 weeks thereafter (up to 8 years)
Title
Change from Baseline at Week 24 in Log2 N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Description
The change from baseline at week 24 in log2 NT-proBNP will be reported.
Time Frame
Baseline up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants between greater than or equal to (>=) 2 and less than (<) 18 years of age weighing >=9 kilogram (kg) at randomization Pulmonary arterial hypertension (PAH) diagnosis confirmed by documented historical right heart catheterization (RHC) performed at any time before participant's screening PAH (World Health Organization [WHO] Group 1), including participants with Down syndrome, of the following etiologies: Idiopathic PAH (IPAH); Heritable PAH (HPAH); PAH associated with congenital heart disease (PAH-associated with congenital heart disease [aCHD]) (PAH with coincidental CHD [that is, a small atrial septal defect, ventricular septal defect, or patent ductus arteriosus that does not itself account for the development of elevated PVR] and if approved by the BCAC) and Post-operative PAH (persisting / recurring/ developing >=6 months after repair of CHD); Drug or toxin-induced; PAH associated with Human immunodeficiency virus (HIV) WHO functional class (FC) II and III Participants treated with at least 1 PAH-specific treatment, example, an Endothelin receptor antagonist (ERA) and/or a Phosphodiesterase type-5 (PDE-5) inhibitor/soluble guanylate cyclase stimulator, provided that the treatment dose(s) has been stable for at least 3 months prior to first dose of study intervention Exclusion Criteria: PAH due to portal hypertension, schistosomiasis, pulmonary veno-occlusive disease, and/or pulmonary capillary hemangiomatosis PAH associated with Eisenmenger syndrome Previous exposure to Uptravi (selexipag) Known concomitant life-threatening disease with a life expectancy <12 months Pregnant, planning to become pregnant, or lactating Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Actelion Clinical Trial
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Childrens Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Congenital Heart Center of the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Detroit Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Childrens Hospital Of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
University of Virginia Division of Pediatric Cardiology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Queensland CHILDREN'S HOSPITAL
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Facility Name
State Institution Republican Scientific And Practical Center For Pediatric Surgery
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Health Institution 4Th City Children'S Clinical Hospital
City
Minsk
ZIP/Postal Code
220118
Country
Belarus
Facility Name
ULB Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Complexo de Prevencao,Diagnostico,Terapia e Reabilitacao Respiratoria LTDA Hospital Dia do Pulmao
City
Blumenau
ZIP/Postal Code
89030-101
Country
Brazil
Facility Name
Fundacao Universitaria de Cardiologia - Instituto de Cardiologia e Transplantes do DF
City
Brasilia
ZIP/Postal Code
70310-500
Country
Brazil
Facility Name
Hospital Pequeno Principe
City
Curitiba
ZIP/Postal Code
80250-060
Country
Brazil
Facility Name
Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
City
Fortaleza
ZIP/Postal Code
60840-285
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Fundacao Universitaria de Cardiologia
City
Porto Alegre
ZIP/Postal Code
90620-001
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericordia de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil
Facility Name
Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Hospital For Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Beijing Anzhen Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Guangzhou Women And Children's Medical Center
City
Guangzhou
ZIP/Postal Code
510623
Country
China
Facility Name
Qingdao Women and Children's Hospital
City
Qingdao
ZIP/Postal Code
266000
Country
China
Facility Name
Shanghai Children's Medical Center
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Children's Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
201102
Country
China
Facility Name
The General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110000
Country
China
Facility Name
Clinica San Rafael
City
Bogota
ZIP/Postal Code
0000000
Country
Colombia
Facility Name
Fundacion Neumologica Colombiana
City
Bogota
ZIP/Postal Code
0000000
Country
Colombia
Facility Name
Fundacion Santa Fe de Bogota
City
Bogota
Country
Colombia
Facility Name
Clínica Imbanaco S.A.S.
City
Cali
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Fundacion Cardiovascular de Colombia
City
Piedecuesta
ZIP/Postal Code
681017
Country
Colombia
Facility Name
Hospital Universidad del Norte
City
Soledad
ZIP/Postal Code
0000000
Country
Colombia
Facility Name
New Children's Hospital of the Helsinki University Hospital (HUS)
City
Helsinki
ZIP/Postal Code
29
Country
Finland
Facility Name
Hôpital Cardiologique - Chru Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital de la Timone
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Arnaud de Villeneuve
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Necker - Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Cardiologique Du Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Chu Hopital Des Enfants
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Universitätsklinikum Freiburg Zentrum
City
Freiburg
ZIP/Postal Code
70106
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Gottsegen György Országos Kardiológiai Intézet
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Our Lady's Children's Hospital
City
Dublin
Country
Ireland
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Universtà Degli Studi Di Padova
City
Padova
Country
Italy
Facility Name
Ospedale Pediatrico Bambin Gesù
City
Roma
ZIP/Postal Code
00193
Country
Italy
Facility Name
IRCCS Policlinico San Donato
City
S. Donato Milanese
ZIP/Postal Code
20097
Country
Italy
Facility Name
AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Pusan National University Yangsan Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Vilnius University Hospital Santariskiu Clinics
City
Vilnius
ZIP/Postal Code
LT08661
Country
Lithuania
Facility Name
National Heart Institute
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
CICUM San Miguel
City
Guadalajara
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas
City
Mexico
ZIP/Postal Code
52787
Country
Mexico
Facility Name
Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
City
Monterrey
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Uniwersytecki Szpital Dzieciecy w Krakowie
City
Kraków
ZIP/Postal Code
30-663
Country
Poland
Facility Name
Szpital Kliniczny im. Karola Jonschera
City
Poznan
ZIP/Postal Code
60-572
Country
Poland
Facility Name
Instytut Pomnik - Centrum Zdrowia Dziecka
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny we Wroclawiu
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Slaskie Centrum Chorob Serca
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Hospital De Santa Marta
City
Lisboa
ZIP/Postal Code
1169-024
Country
Portugal
Facility Name
Centro Hospitalar de São João, EPE
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Kazan State Medical University
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Kazan State Medical University
City
Kazan
ZIP/Postal Code
420059
Country
Russian Federation
Facility Name
Cardiovascular Pathology Research Institute of Siberian Branch of RAMS
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Childrens City Clinical Hospital n.a. Bashlyaeva
City
Moscow
ZIP/Postal Code
125373
Country
Russian Federation
Facility Name
Veltischev Research and Clinical Institute for Pediatrics of the Pirogov RNRMU
City
Moscow
ZIP/Postal Code
125412
Country
Russian Federation
Facility Name
Samara Regional Clinical Cardiological Dispensary
City
Samara
ZIP/Postal Code
443070
Country
Russian Federation
Facility Name
Univerzitetska Dečja Klinika
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Hosp. Univ. A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hosp. Sant Joan de Deu
City
Esplugues de Llobregat
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hosp. Gral. Univ. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Drottning Silvias barn- och ungdomssjukhus
City
Gothenburg
ZIP/Postal Code
416 50
Country
Sweden
Facility Name
Skanes universitetssjukhus
City
Lund
ZIP/Postal Code
222 42
Country
Sweden
Facility Name
Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813414
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chiang Mai University Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Songklanagarind hospital
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Cukurova Balcali Hospital Application and Research Center
City
Adana
ZIP/Postal Code
01380
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
CAPA Istanbul University Medical Faculty
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Mehmet Akif Ersoy Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Name
Izmir Tepecik Training and Research Hospital
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Name
Dnipropetrovsk clinical medical center of Mother and Child after prof. Rudnev
City
Dnipro
ZIP/Postal Code
49006
Country
Ukraine
Facility Name
MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'
City
Dnipro
ZIP/Postal Code
49070
Country
Ukraine
Facility Name
Scientific Practical Medical Center for Pediatric Cardiology and Cardio Surgery of the MOH
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
MI Zaporizhzhia Regional Clinical Childrens Hospital of Zaporizhzhia Regional Council
City
Zaporizhzhya
ZIP/Postal Code
69063
Country
Ukraine
Facility Name
Hanoi Medical University Hospital
City
Hanoi
Country
Vietnam
Facility Name
Tam Anh Hospital
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
University Medical Center Ho Chi Minh city
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
Children's Hospital 1
City
Ho Chi Minh
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension

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