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NCT04175600 · ClinicalTrials.gov registry record · Phase 3
A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension
A Phase 3 study of Hypertension, Pulmonary, sponsored by Actelion.
- Active
- Registry status
- Phase 3
- Development phase
- 138
- Enrollment target
- 20
- Study locations
NCT04175600: Active Phase 3 study of Hypertension, Pulmonary, sponsored by Actelion.
NCT04175600 is a Phase 3 study of Hypertension, Pulmonary that is active but no longer recruiting, run by Actelion. The registered enrollment target is 138 participants, below the 731-participant average among 10 other Hypertension, Pulmonary trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04175600, a Phase 3 study of Hypertension, Pulmonary, is active but no longer recruiting, sponsored by Actelion.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 138 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Time to disease progression: time from randomization to first Clinical Event Committee (CEC)-confirmed disease progression event occurring between date of randomization until double-blind end date (DBED) + 7 days. Disease progression event as adjudicated by CEC, defined as any of the following: death (all causes); atrial septostomy or Potts' anastomosis, or registration on lung transplant list; hospitalization due to worsening pulmonary arterial hypertension (PAH); clinical worsening of PAH. Cli
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 |
What the registry record for NCT04175600 still lists
NCT04175600 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 731-participant average among 10 other Hypertension, Pulmonary trials with a reported enrollment target (81% lower).
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.
NCT04175600 names 20 study sites across 13 states, led by Other, California, Arizona.
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.
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).
Who is sponsoring clinical trial NCT04175600?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04175600's enrollment target sits among peer trials
138 5th of 10 higher than 6 of 10 other Hypertension, Pulmonary trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension, Pulmonary trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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