Trials / Withdrawn
WithdrawnNCT05731492
A Study of Macitentan in Children Below 2 Years of Age
A Multicenter, Open-label, Single-arm Study to Assess the Pharmacokinetics and Safety of Macitentan in Children Aged 1 Month to <2 Years With Pulmonary Arterial Hypertension
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 1 Month – 2 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to learn what happens to macitentan and its active metabolite (aprocitentan) in the body of children aged between 1 month and 2 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Macitentan | Macitentan will be administered orally. |
Timeline
- Start date
- 2024-03-14
- Primary completion
- 2024-04-01
- Completion
- 2024-04-01
- First posted
- 2023-02-16
- Last updated
- 2025-03-30
Locations
4 sites across 2 countries: Germany, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05731492. Inclusion in this directory is not an endorsement.