A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-503042-42-00

Acronym

AC-065A203

Enrollment

Registered

2023-08-11

Start date

2018-07-23

Completion date

Unknown

Last updated

2025-09-29

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

Primary pharmacokinetic (PK) endpoint: - Model-based exposure (AUCτ,ss, combined) of selexipag and ACT- 333679 corrected for their potency, determined during the 12 weeks up- titration period

Interventions

DRUGJNJ-67896049

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Primary pharmacokinetic (PK) endpoint: - Model-based exposure (AUCτ,ss, combined) of selexipag and ACT- 333679 corrected for their potency, determined during the 12 weeks up- titration period	—

Countries

France, Germany, Hungary

Outcome results

None listed

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