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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 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.

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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.

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

FieldValue
Enrollment Target 138 participants
Start Date 2020-01-16
Est. Completion 2027-10-01
Phase Phase 3

Sponsor

Actelion

63 total trials

What the Registry Record Tells You About NCT04175600

The ClinicalTrials.gov registry entry for NCT04175600 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 731-participant average among 10 other Hypertension, Pulmonary trials with a reported enrollment target (81% lower). The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.