Phase 3 N=64 Randomized Treatment

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

Pulmonary Arterial Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01223352 ↗

Enrolled (actual)

Serious AEs

15.6%

Results posted

Jun 2017

Primary outcome: Primary: Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan — 7275.1; 8535.4 h*ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: bosentan (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Actelion
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan	7275.1; 8535.4	—

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.

Eligibility Criteria

Inclusion Criteria

PAH diagnosis confirmed with right heart catheterization (RHC):
Idiopathic or heritable PAH, or
Associated PAH persisting after complete repair of a congenital heart defect (PAH has to be persistent for at least 6 months after surgery) or
PAH-Congenital Heart Disease (PAH-CHD) associated with systemic-to-pulmonary shunts (after global amendment dated 09 May 2012)
World Health Organization functional Class (WHO FC) I, II or III
Male or female ≥ 3 months and 1.5 times the upper limit of normal range.
Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
Hemoglobin and/or hematocrit levels < 75% of the lower limit of normal range.
Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible Tracleer tablet
Treatment with forbidden medication within 2 weeks or at least 5 times the half-life prior to randomization, whichever is the longest:
Glibenclamide (glyburide)
Cyclosporin A
Sirolimus
Tacrolimus
Fluconazole
Rifampicin (rifampin)
Ritonavir
Co-administration of CYP2C9 inhibitors (e.g., amiodarone, voriconazole) and moderate/strong CYP3A4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole, diltiazem, itraconazole)
Endothelin receptor antagonists (ERAs) other than bosentan
Treatment with another investigational drug within 1 month prior to randomization or planned treatment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01223352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.