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
Sites (112)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queensland Children's Hospital Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Completed |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| MHAT National Heart Hospital EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Complexo de Prevencao,Diagnostico,Terapia e Reabilitacao Respiratoria LTDA Hospital Dia do Pulmao Coordinator of this site? Confirm its status | Blumenau | Brazil | Unknown status |
| Fundacao Universitaria de Cardiologia - Instituto de Cardiologia e Transplantes do DF Coordinator of this site? Confirm its status | Brasília | Brazil | Unknown status |
| Hospital Pequeno Príncipe Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| Fundacao Universitaria de Cardiologia Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Irmandade Santa Casa de Misericordia de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Irmandade Santa Casa de Misericordia de Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| State Institution Republican Scientific And Practical Center For Pediatric Surgery Coordinator of this site? Confirm its status | Minsk | Belarus | Unknown status |
| Health Institution 4Th City Children'S Clinical Hospital Coordinator of this site? Confirm its status | Minsk | Belarus | Unknown status |
| Stollery Children'S Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Centre Hospitalier Universitaire Vaudois (CHUV) Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Guangzhou Women And Childrens Medical Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Qingdao Women and Children's Hospital 1 Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Qingdao Women and Children's Hospital Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shanghai Childrens Medical Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Children's Hospital Of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The General Hospital of Northern Theater Command Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Clinica San Rafael Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Fundacion Neumologica Colombiana Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Fundacion Santa Fe de Bogota Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Clinica Imbanaco S.A.S Coordinator of this site? Confirm its status | Cali | Colombia | Unknown status |
| Fundacion Cardiovascular de Colombia Coordinator of this site? Confirm its status | Piedecuesta | Colombia | Unknown status |
| Hospital Universidad del Norte Coordinator of this site? Confirm its status | Soledad | Colombia | Unknown status |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Active, not recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Heidelberg University Hospital AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Herzzentrum Leipzig GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Active, not recruiting |
| Klinikum Der Universitat Munchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Sant Joan De Deu Barcelona Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital For Children And Adolescents Coordinator of this site? Confirm its status | Helsinki | Finland | Completed |
| Hopital Jeanne De Flandre Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Gottsegen National Cardiovascular Center Coordinator of this site? Confirm its status | Budapest | Hungary | Active, not recruiting |
| Childrens Health Ireland Coordinator of this site? Confirm its status | Dublin | Ireland | Completed |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Bambino Gesu Childrens Hospital Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Unknown status |
| VIlnius University Hospital Coordinator of this site? Confirm its status | Vilnius | Lithuania | Completed |
| CICUM San Miguel Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas Coordinator of this site? Confirm its status | México | Mexico | Unknown status |
| Unidad de Investigacion Clinica en Medicina S.C. (UDICEM) Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| National Heart Institute Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Childrens Memorial Health Institute Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Wojewodzki Szpital Specjalistyczny We Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Śląskie Centrum Chorób Serca w Zabrzu Coordinator of this site? Confirm its status | Zabrze | Poland | Active, not recruiting |
| Centro Hospitalar Universitario Lisboa Central E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Active, not recruiting |
| Sao Joao University Hospital Center Coordinator of this site? Confirm its status | Porto | Portugal | Active, not recruiting |
| Univerzitetska Dečja Klinika Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Kazan State Medical University Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| Kazan State Medical University 1 Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| Scientific and Research Institution of Cardiovascular Diseases Complex Problems Coordinator of this site? Confirm its status | Kemerovo | Russia | Unknown status |
| Veltischev Research and Clinical Institute for Pediatrics of the Pirogov RNRMU Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Childrens City Clinical Hospital n.a. Bashlyaeva Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Samara Regional Clinical Cardiological Dispensary Coordinator of this site? Confirm its status | Samara | Russia | Unknown status |
| Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Gothenburg | Sweden | Completed |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Completed |
| Chiang Mai University Hospital Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Songklanagarind Hospital Coordinator of this site? Confirm its status | Songkhla | Thailand | Unknown status |
| Kaohsiung Veterans General Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery' Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Dnipropetrovsk clinical medical center of Mother and Child after prof. Rudnev Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Scientific Practical Medical Center for Pediatric Cardiology and Cardio Surgery of the MOH Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| MI Zaporizhzhia Regional Clinical Childrens Hospital of Zaporizhzhia Regional Council Coordinator of this site? Confirm its status | Zaporizhzhya | Ukraine | Unknown status |
| Childrens Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Virginia Division of Pediatric Cardiology Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Detroit Medical Center Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Congenital Heart Center of the University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| UCLA Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Childrens Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Phoenix Children s Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Primary Children's Hospital Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| UCSF Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Hanoi Medical University Hospital Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
| Children's Hospital 1 Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
| Tam Anh Hospital Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
| University Medical Center Ho Chi Minh City Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
| Cukurova Balcali Hospital Application and Research Center Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Hacettepe University Medical Faculty Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| CAPA Istanbul University Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Mehmet Akif Ersoy Training and Research Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Izmir Tepecik Training and Research Hospital Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.