A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day

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 - FUTURE 3

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021825-11-NL

Enrollment

Registered

2010-11-03

Start date

2011-04-28

Completion date

Unknown

Last updated

2013-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1 Level: LLT Classification code 10064908 Term: Associated with (APAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10064909 Term: Idiopathic (IPAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10064910 Term: Familial (FPAH) System Organ Class: 10038738 -

Interventions

Trade Name: Tracleer Product Name: bosentan Pharmaceutical Form: Dispersible tablet INN or Proposed INN: BOSENTAN MONOHYDRATE CAS Number: 157212-55-0 Other descriptive name: Ro-47-0203/029 Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. PAH diagnosis confirmed with 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-CHD (associated with systemic-to-pulmonary shunts, including Eisenmenger syndrome), with PVR > 8 Wood Units and Qp/Qs =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. PAH etiologies other than listed above 2. Non-stable disease status 3. Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled iloprost. 4. Systolic blood pressure 1.5 times the upper limit of normal range. 6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C 7. Hemoglobin and/or hematocrit levels < 75% of the lower limit of normal range. 8. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible Tracleer tablet. 9. 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 10. Treatment with another investigational drug within 1 month prior to randomization or planned treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: to investigate the pharmacokinetics (PK) of the pediatric formulation of bosentan at doses of 2 mg/kg b.i.d. and 2 mg/kg t.i.d. in children with pulmonary arterial hypertension (PAH) from = 3 months to < 12 years of age.;Secondary Objective: to evaluate efficacy, tolerability, and safety of bosentan in children with PAH from = 3 months to < 12 years of age.;Primary end point(s): The main PK endpoint is defined as the daily exposure to bosentan, i.e., AUC over a period of 24 h (AUC(0-24h)), and calculated as a multiple of the exposure over a dosing interval (AUCt), 3×AUCt and 2xAUCt for three times and two times daily dosing, respectively. ;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: to investigate the pharmacokinetics (PK) of the pediatric formulation of bosentan at doses of 2 mg/kg b.i.d. and 2 mg/kg t.i.d. in children with pulmonary arterial hypertension (PAH) from = 3 months to < 12 years of age.;Secondary Objective: to evaluate efficacy, tolerability, and safety of bosentan in children with PAH from = 3 months to < 12 years of age.;Primary end point(s): The main PK endpoint is defined as the daily exposure to bosentan, i.e., AUC over a period of 24 h (AUC(0-24h)), and calculated as a multiple of the exposure over a dosing interval (AUCt), 3×AUCt and 2xAUCt for three times and two times daily dosing, respectively. ;Timepoint(s) of evaluation of this end point: Not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Australia, Belarus, Bulgaria, China, Czech Republic, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Serbia, South Africa, Spain, Ukraine, United States

Contacts

Public ContactGLOBAL MEDICAL INFORMATION

Actelion Pharmaceuticals Ltd.

medinfo@actelion.com-

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026