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A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension
NCT04175600 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Selexipag
- DRUG Standard of Care (SOC): Endothelin receptor antagonist
- DRUG SOC: Phosphodiesterase type 5 (PDE-5) inhibitor
- DRUG SOC: Soluble guanylate cyclase stimulator
Study Locations (20)
Other
- Queensland CHILDREN'S HOSPITAL — South Brisbane
- State Institution Republican Scientific And Practical Center For Pediatric Surgery — Minsk
- Health Institution 4Th City Children'S Clinical Hospital — Minsk
- ULB Hôpital Erasme — Brussels
- Universitair Ziekenhuis Gent — Ghent
- Universitaire Ziekenhuizen Leuven — Leuven
- Complexo de Prevencao,Diagnostico,Terapia e Reabilitacao Respiratoria LTDA Hospital Dia do Pulmao — Blumenau
California
- UCLA Medical Center — Los Angeles
- UCSF — San Francisco
Arizona
- Phoenix Children's Hospital — Phoenix
Colorado
- Childrens Hospital Colorado — Aurora
District of Columbia
- Children's National Medical Center — Washington D.C.
Florida
- Congenital Heart Center of the University of Florida — Gainesville
Indiana
- Riley Hospital for Children — Indianapolis
Michigan
- Detroit Medical Center — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2020-01-16 |
| Est. Completion | 2027-10-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04175600
The ClinicalTrials.gov registry entry for NCT04175600 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hypertension, Pulmonary appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04175600 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04175600 about?
NCT04175600 is a clinical study titled "A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension". 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.
What is the current status of trial NCT04175600?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 138 participants. The study started on 2020-01-16. Estimated completion is 2027-10-01.
What conditions does trial NCT04175600 study?
This clinical trial studies the following conditions: Hypertension, Pulmonary. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04175600?
The interventions under investigation include: Placebo (DRUG), Selexipag (DRUG), Standard of Care (SOC): Endothelin receptor antagonist (DRUG), SOC: Phosphodiesterase type 5 (PDE-5) inhibitor (DRUG), SOC: Soluble guanylate cyclase stimulator (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04175600?
This trial is sponsored by Actelion, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04175600 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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