A Phase 3 interventional study of Bosentan in Pulmonary Arterial Hypertension, sponsored by Actelion. Completed. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Actelion · Phase 3, Interventional, and Treatment
The aim of the study is to demonstrate that the exposure to bosentan in children with idiopathic pulmonary arterial hypertension (PAH) or familial pulmonary arterial hypertension, using a pediatric formulation, is similar to that in adults with PAH and to evaluate the tolerability and safety of a pediatric formulation of bosentan in this patient population.
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's enrollment of 36 is close to the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Actelion is the lead sponsor of 140 studies on the registry; 1 is open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 24 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
PAH treatment-naïve patients or patients already treated with either:
Exclusion Criteria:
The initial dose of bosentan was 2 mg/kg b.i.d. for 4 weeks. After 4 weeks, the initial dose was up-titrated to the maintenance dose of 4 mg/kg b.i.d. up to the end of the study treatment at Week 12. If the maintenance dose was not well tolerated, the dose could be down-titrated to the initial dose.
Drug: Bosentan
Pediatric oral formulation of bosentan, i.e., 32 mg dispersible and breakable tablets
Also known as: ACT-050088, Ro 47-0203
Area under the plasma concentration-time curve during a dose interval (AUCt) for bosentan
AUCt was assessed at steady state (i.e., after at least 2 weeks of treatment with a same dose of the study drug) over 12 hours .
Time frame: At pre-dose and 0.5h, 1h, 3h, 7.5h, and 12h post-dose
Maximum plasma concentration (Cmax) of bosentan and its metabolites
Maximum observed plasma concentration for bosentan and its metabolites was directly derived from their respective plasma concentration-time curves.
Time frame: At pre-dose and 0.5h, 1h, 3h, 7.5h, and 12h post-dose
Time to reach the maximum plasma concentration (tmax) of bosentan and its metabolites
Time frame: At pre-dose and 0.5h, 1h, 3h, 7.5h, and 12h post-dose
Area under the plasma concentration-time curve during a dose interval (AUCt) for the metabolites of bosentan
AUCt was assessed at steady state (i.e., after at least 2 weeks of treatment with a same dose of the study drug) over 12 hours.
Time frame: At pre-dose and 0.5h, 1h, 3h, 7.5h, and 12h post-dose
No study locations are listed for this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension→
Actelion