A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged ≥2 to <18 years with Pulmonary Arterial Hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501012-34-00

Acronym

AC-065A310

Enrollment

Registered

2023-03-13

Start date

2020-02-27

Completion date

Unknown

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Brief summary

Time to disease progression from randomization up to 7 days after study treatment discontinuation.

Interventions

DRUGJNJ-67896049

DRUGPL1

DRUGPL4

DRUGTracleer 32 mg dispersible tablets

DRUGPL2

DRUGPL3

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Time to disease progression from randomization up to 7 days after study treatment discontinuation.	—

Countries

Belgium, Bulgaria, Finland, France, Germany, Hungary, Ireland, Italy, Lithuania, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026