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NCT03492177Active, not recruitingPhase 2

A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension

A Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial Hypertension

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (\>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
63 (actual)
First submitted
3 Apr 2018
Start date
23 Jul 2018
Primary completion date
28 Mar 2022
Lead sponsor
Actelion
NCT number
NCT03492177
EU CT number
2022-503042-42-00
EudraCT number
2018-000145-39

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 63
  • From 23 Jul 2018 to the primary completion date, 28 Mar 2022
  • 33 sites in 16 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 treatment with Uptravi (selexipag) within 2 weeks prior to enrollment
  • Participants having received prostacyclin (epoprostenol) or prostacyclin analogs (that is, treprostinil, iloprost, beraprost) within 2 months prior to enrollment or are scheduled to receive any of these compounds during the trial
  • Treatment with another investigational drug within 4 weeks prior to enrollment
  • Clinical signs of hypotension that in the investigator's judgment would preclude initiation of a PAH-specific therapy

Other illness

  • Participants with PAH due to portal hypertension, schistosomiasis, pulmonary veno-occlusive disease (PVOD) and/or pulmonary capillary hemangiomatosis
  • Participants with PAH associated with Eisenmenger syndrome
  • Participants with cyanotic congenital cardiac lesions such as transposition of the great arteries, truncus arteriosus, univentricular heart or pulmonary atresia with ventricular septal defect, as well as Participants with Fontan-palliation
  • Participants with pulmonary hypertension due to lung disease
  • Uncontrolled thyroid disease as per investigator judgment
  • Known severe or moderate hepatic impairment
  • Participants with severe renal insufficiency
  • Known hypersensitivity to the investigational treatment or to any of the excipients of the drug formulations

Lab values

  • Hemoglobin or hematocrit \< 75 percentage (%) of the lower limit of normal range

Other

  • Participants with moderate to large left-to-right shunts
  • History, or current suspicion of intussusception or ileus or gastrointestinal obstruction as per investigator's judgment

Who the study is looking for

  • Signed and dated informed consent by the parent(s) or Legally authorized representative(s) AND assent from developmentally capable children
  • Males or females between greater than or equal to (\>=) 2 and less than (\<) 18 years of age with weight \>= 9 kilograms (kg)
  • Pulmonary arterial hypertension (PAH) diagnosis confirmed by documented historical right heart catheterization (RHC) performed at any time before participant's enrollment
  • PAH with one of the following etiologies:
    • idiopathic (iPAH),
    • heritable (hPAH),
    • associated with congenital heart disease (CHD): PAH with co-incidental CHD; post-operative PAH (persisting/ recurring/ developing \>= 6 months after repair of CHD)
    • Drug or toxin-induced
    • PAH associated with HIV
    • PAH associated with connective tissue disease
  • Word Health Organization functional class (WHO FC) II to III
  • Participants treated with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor provided that the treatment dose(s) has been stable for at least 3 months prior to enrollment, or participants who are not candidates for these therapies
  • Females of childbearing potential must have a negative pregnancy test at Screening and at Enrollment, and must agree to undertake monthly pregnancy tests, and to use a reliable method of contraception (if sexually active) from screening up to study drug discontinuation plus 30 days (EOS)

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

Full criteria on ClinicalTrials.gov

Sites (33)

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

SiteCityCountrySite status
UZ Gent
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
State Institution Republican Scientific And Practical Center For Pediatric Surgery
Coordinator of this site? Confirm its status
MinskBelarusUnknown status
Health Institution 4Th City Children'S Clinical Hospital
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MinskBelarusUnknown status
Centre Hospitalier Sainte Justine
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MontrealCanadaUnknown status
Beijing Anzhen Hospital
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BeijingChinaUnknown status
Shanghai Childrens Medical Center
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ShanghaiChinaUnknown status
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Hopital Des Enfants
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Toulouse Cedex 9FranceActive, not recruiting
Great Ormond Street Hospital
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LondonUnited KingdomUnknown status
Gottsegen National Cardiovascular Center
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BudapestHungaryActive, not recruiting
Schneider Children's Medical Center
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Petach TikvahIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Sarawak Heart Center
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Kota SamarahanMalaysiaUnknown status
Institut Jantung Negara - National Heart Institute
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Kuala LumpurMalaysiaUnknown status
Wojewodzki Szpital Specjalistyczny We Wroclawiu
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WroclawPolandUnknown status
Institut za Zdravstvenu Zastitu Majke i Deteta Srbije Dr Vukan Cupic
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BelgradeSerbiaUnknown status
Univerzitetska Dečja Klinika
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BelgradeSerbiaUnknown status
Kazan State Medical University
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Kazan'RussiaUnknown status
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
Coordinator of this site? Confirm its status
KemerovoRussiaUnknown status
Moscow Scientific Research Institute For Pediatrics And Childrens Surgery Of Rosmedtechnologies
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
Saint Petersburg State Pediatric Medical University
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Saint PetersburgRussiaUnknown status
Almazov National Medical Research Center of the Ministry of Health of the Russian Federation
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Saint PetersburgRussiaUnknown status
Samara Regional Clinical Cardiological Dispensary
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SamaraRussiaUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Municipal Enterprise Of The Dnipropetrovsk Regional Council
Coordinator of this site? Confirm its status
DniproUkraineUnknown status
State Institution Of The Ministry Of Health Of Ukraine
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KievUkraineUnknown status
Lviv Regional Clinical Hospital
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LvivUkraineUnknown status
Municipal Institution Of The Zaporizhzhya Regional Council
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ZaporizhzhyaUkraineUnknown status
Children'S Hospital Cardiac Care Center University Of Colorado
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AuroraUnited StatesUnknown status
University of Iowa Hospital
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Iowa CityUnited StatesUnknown status
Seattle Children's Hospital
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SeattleUnited StatesUnknown status

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