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NCT04175600Active, not recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
138 (actual)
First submitted
8 Nov 2019
Start date
16 Jan 2020
Primary completion date
11 Oct 2024
Lead sponsor
Actelion
NCT number
NCT04175600
EU CT number
2022-501012-34-00
EudraCT number
2019-002817-21

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 138
  • From 16 Jan 2020 to the primary completion date, 11 Oct 2024
  • 112 sites in 32 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous exposure to Uptravi (selexipag)
  • Known concomitant life-threatening disease with a life expectancy \<12 months

Other illness

  • PAH due to portal hypertension, schistosomiasis, pulmonary veno-occlusive disease, and/or pulmonary capillary hemangiomatosis
  • PAH associated with Eisenmenger syndrome
  • Known allergies, hypersensitivity, or intolerance to selexipag or its excipients

Other

  • Pregnant, planning to become pregnant, or lactating

Who the study is looking for

  • 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

Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (112)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Queensland Children's Hospital
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South BrisbaneAustraliaUnknown status
Hopital Erasme
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AnderlechtBelgiumCompleted
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
MHAT National Heart Hospital EAD
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SofiyaBulgariaCompleted
Complexo de Prevencao,Diagnostico,Terapia e Reabilitacao Respiratoria LTDA Hospital Dia do Pulmao
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BlumenauBrazilUnknown status
Fundacao Universitaria de Cardiologia - Instituto de Cardiologia e Transplantes do DF
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BrasíliaBrazilUnknown status
Hospital Pequeno Príncipe
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CuritibaBrazilUnknown status
Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
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FortalezaBrazilUnknown status
Fundacao Universitaria de Cardiologia
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Porto AlegreBrazilUnknown status
Irmandade Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilUnknown status
Irmandade Santa Casa de Misericordia de Sao Paulo
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São PauloBrazilUnknown status
SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
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São PauloBrazilUnknown status
State Institution Republican Scientific And Practical Center For Pediatric Surgery
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MinskBelarusUnknown status
Health Institution 4Th City Children'S Clinical Hospital
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MinskBelarusUnknown status
Stollery Children'S Hospital
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EdmontonCanadaUnknown status
Hospital for Sick Children
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TorontoCanadaUnknown status
Centre Hospitalier Universitaire Vaudois (CHUV)
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LausanneSwitzerlandUnknown status
Beijing Anzhen Hospital
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BeijingChinaUnknown status
Guangzhou Women And Childrens Medical Center
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GuangzhouChinaUnknown status
Qingdao Women and Children's Hospital 1
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QingdaoChinaUnknown status
Qingdao Women and Children's Hospital
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QingdaoChinaUnknown status
Shanghai Childrens Medical Center
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ShanghaiChinaUnknown status
Children's Hospital Of Fudan University
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ShanghaiChinaUnknown status
The General Hospital of Northern Theater Command
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ShenyangChinaUnknown status
Clinica San Rafael
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BogotáColombiaUnknown status
Fundacion Neumologica Colombiana
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BogotáColombiaUnknown status
Fundacion Santa Fe de Bogota
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BogotáColombiaUnknown status
Clinica Imbanaco S.A.S
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CaliColombiaUnknown status
Fundacion Cardiovascular de Colombia
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PiedecuestaColombiaUnknown status
Hospital Universidad del Norte
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SoledadColombiaUnknown status
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
Heidelberg University Hospital AöR
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HeidelbergGermanyActive, not recruiting
Herzzentrum Leipzig GmbH
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LeipzigGermanyActive, not recruiting
Klinikum Der Universitat Munchen AöR
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MunichGermanyActive, not recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Sant Joan De Deu Barcelona
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Esplugues de LlobregatSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital For Children And Adolescents
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HelsinkiFinlandCompleted
Hopital Jeanne De Flandre
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Lille CedexFranceActive, not recruiting
Assistance Publique Hôpitaux de Marseille
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MarseilleFranceActive, not recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
Gottsegen National Cardiovascular Center
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BudapestHungaryActive, not recruiting
Childrens Health Ireland
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DublinIrelandCompleted
Rambam Medical Center
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HaifaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Bambino Gesu Childrens Hospital
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RomeItalyActive, not recruiting
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Pusan National University Yangsan Hospital
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YangsanSouth KoreaUnknown status
VIlnius University Hospital
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VilniusLithuaniaCompleted
CICUM San Miguel
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GuadalajaraMexicoUnknown status
Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas
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MéxicoMexicoUnknown status
Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
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MonterreyMexicoUnknown status
National Heart Institute
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Kuala LumpurMalaysiaUnknown status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu
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PoznanPolandActive, not recruiting
Childrens Memorial Health Institute
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WarsawPolandActive, not recruiting
Wojewodzki Szpital Specjalistyczny We Wroclawiu
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WroclawPolandActive, not recruiting
Śląskie Centrum Chorób Serca w Zabrzu
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ZabrzePolandActive, not recruiting
Centro Hospitalar Universitario Lisboa Central E.P.E.
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LisbonPortugalActive, not recruiting
Sao Joao University Hospital Center
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PortoPortugalActive, not recruiting
Univerzitetska Dečja Klinika
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BelgradeSerbiaUnknown status
Kazan State Medical University
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Kazan'RussiaUnknown status
Kazan State Medical University 1
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Kazan'RussiaUnknown status
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
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KemerovoRussiaUnknown status
Veltischev Research and Clinical Institute for Pediatrics of the Pirogov RNRMU
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MoscowRussiaUnknown status
Childrens City Clinical Hospital n.a. Bashlyaeva
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MoscowRussiaUnknown status
Samara Regional Clinical Cardiological Dispensary
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SamaraRussiaUnknown status
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen
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GothenburgSwedenCompleted
Region Skane Skanes Universitetssjukhus
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LundSwedenCompleted
Chiang Mai University Hospital
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Chiang MaiThailandUnknown status
Songklanagarind Hospital
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SongkhlaThailandUnknown status
Kaohsiung Veterans General Hospital
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Kaohsiung CityTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'
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DniproUkraineUnknown status
Dnipropetrovsk clinical medical center of Mother and Child after prof. Rudnev
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DniproUkraineUnknown status
Scientific Practical Medical Center for Pediatric Cardiology and Cardio Surgery of the MOH
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KyivUkraineUnknown status
MI Zaporizhzhia Regional Clinical Childrens Hospital of Zaporizhzhia Regional Council
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ZaporizhzhyaUkraineUnknown status
Childrens Hospital Colorado
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AuroraUnited StatesUnknown status
University of Virginia Division of Pediatric Cardiology
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CharlottesvilleUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesUnknown status
Detroit Medical Center
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DetroitUnited StatesUnknown status
Congenital Heart Center of the University of Florida
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GainesvilleUnited StatesUnknown status
Texas Children's Hospital
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HoustonUnited StatesUnknown status
Riley Hospital for Children
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IndianapolisUnited StatesUnknown status
UCLA Medical Center
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Los AngelesUnited StatesUnknown status
Childrens Hospital of Philadelphia
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PhiladelphiaUnited StatesUnknown status
Phoenix Children s Hospital
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PhoenixUnited StatesUnknown status
Primary Children's Hospital
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Salt Lake CityUnited StatesUnknown status
UCSF
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San FranciscoUnited StatesUnknown status
Children's National Medical Center
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Washington D.C.United StatesUnknown status
Hanoi Medical University Hospital
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HanoiVietnamUnknown status
Children's Hospital 1
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Ho Chi Minh CityVietnamUnknown status
Tam Anh Hospital
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Ho Chi Minh CityVietnamUnknown status
University Medical Center Ho Chi Minh City
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Ho Chi Minh CityVietnamUnknown status
Cukurova Balcali Hospital Application and Research Center
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AdanaTurkey (Türkiye)Unknown status
Hacettepe University Medical Faculty
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AnkaraTurkey (Türkiye)Unknown status
CAPA Istanbul University Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Mehmet Akif Ersoy Training and Research Hospital
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IstanbulTurkey (Türkiye)Unknown status
Izmir Tepecik Training and Research Hospital
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IzmirTurkey (Türkiye)Unknown status
Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital
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IzmirTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.