NCT01223352

Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension

An Open-label, Prospective Multicenter Study to Assess the Pharmacokinetics, Tolerability, Safety and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 3 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) \<12 years of age.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	bosentan	32 mg quadrisected dispersible tablet. The dosage of bosentan (2 mg/Kg) was adjusted according to the patient's body weight at initiation of the study treatment. Dosage readjustment was permitted after 12 weeks of treatment.

Timeline

• Start date: 2011-03-08
• Primary completion: 2013-04-03
• Completion: 2013-08-19
• First posted: 2010-10-19
• Last updated: 2025-02-04
• Results posted: 2017-06-29

Regulatory

• FDA-regulated drug study