Phase 3
Completed N=64
Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov NCT01223352 ↗Enrolled (actual)
64
Serious AEs
15.6%
Results posted
Jun 2017
Primary outcomePrimary: Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan — 7275.1; 8535.4 h*ng/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan |
7275.1; 8535.4 | — |
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
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. Informational only — not medical advice.