A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Hypertension, Pulmonary
In brief
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.
Key facts
- Study ID
- NCT04175600
- Run by
- Actelion
- People needed
- 138
- Starts
- 2020-01-16
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-07-31
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UCLA Medical Center — Los Angeles, California, United States
- UCSF — San Francisco, California, United States
- Childrens Hospital Colorado — Aurora, Colorado, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- Congenital Heart Center of the University of Florida — Gainesville, Florida, United States
- Riley Hospital for Children — Indianapolis, Indiana, United States
- Detroit Medical Center — Detroit, Michigan, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Childrens Hospital Of Philadelphia — Philadelphia, Pennsylvania, United States
- Texas Children's Hospital — Houston, Texas, United States
- Primary Children's Hospital — Salt Lake City, Utah, United States
- University of Virginia Division of Pediatric Cardiology — Charlottesville, Virginia, United States
- Queensland CHILDREN'S HOSPITAL — South Brisbane, Australia
- State Institution Republican Scientific And Practical Center For Pediatric Surgery — Minsk, Belarus
- Health Institution 4Th City Children'S Clinical Hospital — Minsk, Belarus
- ULB Hôpital Erasme — Brussels, Belgium
- Universitair Ziekenhuis Gent — Ghent, Belgium
- Universitaire Ziekenhuizen Leuven — Leuven, Belgium
- Complexo de Prevencao,Diagnostico,Terapia e Reabilitacao Respiratoria LTDA Hospital Dia do Pulmao — Blumenau, Brazil
- Fundacao Universitaria de Cardiologia - Instituto de Cardiologia e Transplantes do DF — Brasília, Brazil
- Hospital Pequeno Principe — Curitiba, Brazil
- Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes — Fortaleza, Brazil
- Irmandade Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Brazil
- Fundacao Universitaria de Cardiologia — Porto Alegre, Brazil
- Phoenix Children's Hospital — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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