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Pediatric bosentan pharmacokinetics and safety in idiopathic or familial pulmonary arterial hypertension
2004-005157-63Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2005
- Countries
- 1
- Sponsor
- Actelion Pharmaceuticals Ltd
- Modality
- Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Nucleic Acid-Directed Small Molecules → Small Molecules
- Drugs
- bosentan
- Conditions
- Plexogenic Pulmonary Arteriopathypulmonary arterial hypertension (PAH)
01
Overview
Phase 3, open-label, single-arm trial of bosentan in Plexogenic Pulmonary Arteriopathy and pulmonary arterial hypertension (PAH), sponsored by Actelion Pharmaceuticals Ltd. Primary endpoint: Primary pharmacokinetic equivalence. Started Apr 2005; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Bosentan pediatric formulation
Children with idiopathic or familial pulmonary arterial hypertension receiving bosentan pediatric formulation at 2 mg/kg twice daily.
03
Who it enrols
Children with idiopathic or familial pulmonary arterial hypertension; all start bosentan pediatric formulation at 2 mg/kg twice daily regardless of prior bosentan treatment.
04
Endpoints
Primary
Primary pharmacokinetic equivalence
Secondary
Tolerability and safety
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