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Could this pill help kids with rare lung disease?

NCT ID NCT04175600

Disease control Sponsor: Actelion Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study tests whether adding selexipag to standard treatment can delay disease worsening in children aged 2 to 18 with pulmonary arterial hypertension (PAH). About 138 children will receive either selexipag or a placebo, plus their usual medications. The main goal is to see if the drug helps prevent serious events like hospitalization or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Selexipag (a drug taken by mouth to widen blood vessels in the lungs)
What this could lead to
If it works, this could give doctors a new add-on treatment to slow down worsening of pulmonary hypertension in children.
What could go wrong
This is still being tested, so it is not yet proven to work. Side effects are possible, and results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

138 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension pulmonary hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension, pulmonary

Contacts and locations

Locations

  • AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita

    Torino, 10126, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Azienda Ospedaliera Policlinico S. Orsola-Malpighi

    Bologna, 40138, Italy

  • Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital

    Izmir, 35210, Turkey (Türkiye)

  • Beijing Anzhen Hospital

    Beijing, 100029, China

  • CAPA Istanbul University Medical Faculty

    Istanbul, 34093, Turkey (Türkiye)

  • CHU Arnaud de Villeneuve

    Montpellier, 34295, France

  • CICUM San Miguel

    Guadalajara, 44160, Mexico

  • Centre Hospitalier Universitaire Vaudois CHUV

    Lausanne, 1011, Switzerland

  • Chiang Mai University Hospital

    Chiang Mai, 50200, Thailand

  • Children's Hospital 1

    Ho Chi Minh City, Vietnam

  • Children's Hospital of Fudan University

    Shanghai, 201102, China

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Childrens City Clinical Hospital n.a. Bashlyaeva

    Moscow, 125373, Russia

  • Childrens Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Childrens Hospital Of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Chu Hopital Des Enfants

    Toulouse, 31059, France

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Clinica San Rafael

    Bogotá, 0000000, Colombia

  • Clínica Imbanaco S.A.S.

    Cali, 760042, Colombia

  • Complexo de Prevencao,Diagnostico,Terapia e Reabilitacao Respiratoria LTDA Hospital Dia do Pulmao

    Blumenau, 89030-101, Brazil

  • Congenital Heart Center of the University of Florida

    Gainesville, Florida, 32610, United States

  • Cukurova Balcali Hospital Application and Research Center

    Adana, 01790, Turkey (Türkiye)

  • Detroit Medical Center

    Detroit, Michigan, 48201, United States

  • Dnipropetrovsk clinical medical center of Mother and Child after prof. Rudnev

    Dnipro, 49006, Ukraine

  • Drottning Silvias barn- och ungdomssjukhus

    Gothenburg, 416 50, Sweden

  • Fundacao Universitaria de Cardiologia

    Porto Alegre, 90620-001, Brazil

  • Fundacao Universitaria de Cardiologia - Instituto de Cardiologia e Transplantes do DF

    Brasília, 70310-500, Brazil

  • Fundacion Cardiovascular de Colombia

    Piedecuesta, 681017, Colombia

  • Fundacion Neumologica Colombiana

    Bogotá, 0000000, Colombia

  • Fundacion Santa Fe de Bogota

    Bogotá, Colombia

  • Gottsegen György Országos Kardiológiai Intézet

    Budapest, 1096, Hungary

  • Guangzhou Women And Children's Medical Center

    Guangzhou, 510623, China

  • Hacettepe University Medical Faculty

    Ankara, 06230, Turkey (Türkiye)

  • Hanoi Medical University Hospital

    Hanoi, Vietnam

  • Health Institution 4Th City Children'S Clinical Hospital

    Minsk, 220118, Belarus

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289, Germany

  • Hopital de la Timone

    Marseille, 13385, France

  • Hosp Univ A Coruna

    A Coruña, 15006, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28009, Spain

  • Hosp. Sant Joan de Deu

    Esplugues de Llobregat, 08950, Spain

  • Hosp. Univ. La Paz

    Madrid, 28046, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital For Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Hospital Pequeno Principe

    Curitiba, 80250-060, Brazil

  • Hospital Universidad del Norte

    Soledad, 0000000, Colombia

  • Hôpital Cardiologique - Chru Lille

    Lille, 59037, France

  • Hôpital Cardiologique Du Haut-Lévêque

    Pessac, 33604, France

  • Hôpital Necker - Enfants Malades

    Paris, 75015, France

  • IRCCS Policlinico San Donato

    S. Donato Milanese, 20097, Italy

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04-730, Poland

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090, Brazil

  • Irmandade Santa Casa de Misericordia de Sao Paulo

    São Paulo, 01221-020, Brazil

  • Izmir Tepecik Training and Research Hospital

    Izmir, 35020, Turkey (Türkiye)

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813414, Taiwan

  • Kazan State Medical University

    Kazan', 420012, Russia

  • Kazan State Medical University 1

    Kazan', 420059, Russia

  • Klinikum der Universitaet Muenchen

    München, 81377, Germany

  • MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'

    Dnipro, 49070, Ukraine

  • MI Zaporizhzhia Regional Clinical Childrens Hospital of Zaporizhzhia Regional Council

    Zaporizhzhya, 69063, Ukraine

  • Mehmet Akif Ersoy Training and Research Hospital

    Istanbul, 34303, Turkey (Türkiye)

  • Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead

    Sofia, 1309, Bulgaria

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Heart Institute

    Kuala Lumpur, 50400, Malaysia

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • New Children's Hospital of the Helsinki University Hospital (HUS)

    Helsinki, 29, Finland

  • Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas

    México, 52787, Mexico

  • Ospedale Pediatrico Bambin Gesù

    Roma, 00193, Italy

  • Our Lady's Children's Hospital

    Dublin, Ireland

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Pusan National University Yangsan Hospital

    Yangsan, 50612, South Korea

  • Qingdao Women and Children's Hospital

    Qingdao, 266000, China

  • Qingdao Women and Children's Hospital 1

    Qingdao, 266000, China

  • Queensland CHILDREN'S HOSPITAL

    South Brisbane, 4101, Australia

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

    São Paulo, 04024 002, Brazil

  • Samara Regional Clinical Cardiological Dispensary

    Samara, 443070, Russia

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Scientific Practical Medical Center for Pediatric Cardiology and Cardio Surgery of the MOH

    Kyiv, 04050, Ukraine

  • Scientific and Research Institution of Cardiovascular Diseases Complex Problems

    Kemerovo, 650002, Russia

  • Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes

    Fortaleza, 60840-285, Brazil

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 120-752, South Korea

  • Shanghai Childrens Medical Center

    Shanghai, 200127, China

  • Sheba Medical Center

    Ramat Gan, 52621, Israel

  • Skanes universitetssjukhus

    Lund, 222 42, Sweden

  • Slaskie Centrum Chorob Serca

    Zabrze, 41-800, Poland

  • Songklanagarind hospital

    Songkhla, 90110, Thailand

  • State Institution Republican Scientific And Practical Center For Pediatric Surgery

    Minsk, 220013, Belarus

  • Stollery Children's Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • Szpital Kliniczny im Karola Jonschera

    Poznan, 60 572, Poland

  • Tam Anh Hospital

    Ho Chi Minh City, 700000, Vietnam

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The General Hospital of Northern Theater Command

    Shenyang, 110000, China

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

  • UCSF

    San Francisco, California, 94158, United States

  • ULB Hôpital Erasme

    Brussels, 1070, Belgium

  • Uls Sao Joao - Hosp. Sao Joao

    Porto, 4200 319, Portugal

  • Uls Sao Jose - Hosp. Santa Marta

    Lisbon, 1169-024, Portugal

  • Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)

    Monterrey, 64718, Mexico

  • Universitaetsklinikum Heidelberg

    Heidelberg, D-69120, Germany

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000, Belgium

  • University Medical Center Ho Chi Minh city

    Ho Chi Minh City, 700000, Vietnam

  • University of Virginia Division of Pediatric Cardiology

    Charlottesville, Virginia, 22908, United States

  • Universitätsklinikum Freiburg Zentrum

    Freiburg im Breisgau, 70106, Germany

  • Universta Degli Studi Di Padova

    Padova, Italy

  • Univerzitetska Dečja Klinika

    Belgrade, 11000, Serbia

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, 30-663, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 952, Poland

  • Veltischev Research and Clinical Institute for Pediatrics of the Pirogov RNRMU

    Moscow, 125412, Russia

  • Vilnius University Hospital Santariskiu Clinics

    Vilnius, LT08661, Lithuania

  • Wojewodzki Szpital Specjalistyczny we Wroclawiu

    Wroclaw, 51 124, Poland

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Other studies related to the condition(s) this trial covers.