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

NCT03492177 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-05-08

Study results available
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Summary

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.

Conditions

Interventions

DRUG

selexipag (Uptravi)

Film-coated tablets for oral administration

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Catherine Boisson · Actelion

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-23
Primary Completion
2022-03-28
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Hungary
  • Israel
  • Malaysia
  • Poland
  • Russia
  • Serbia
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03492177 on ClinicalTrials.gov