A 1 year follow-up research project for children with pulmonary arterial hypertension (PAH) that participated in the FUTURE 3 core study. This is to find out how well bosentan is tolerated and safe when taken either two or three times a day

A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021793-12-DE

Enrollment

Registered

2011-02-01

Start date

2011-04-04

Completion date

Unknown

Last updated

2015-03-02

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: 16.1 Level: LLT Classification code 10064910 Term: Familial (FPAH) System Organ Class: 100000004855 MedDRA version: 16.1 Level: LLT Classification code 10064909 Term: Idiopathic (IPAH) System Organ Class: 100000004855 MedDRA version: 16.1 Level: LLT Classification code 10064908 Term: Associated with (APAH) System Organ Class: 100000004855

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. Patients who completed the FUTURE 3 core study (AC-052-373) or prematurely discontinued due to PAH-progression, if bosentan was not permanently discontinued 2. Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial by the investigator at the end of FUTURE 3 core study (AC-052-373). 3. Signed informed consent by the parents or the legal representatives prior to any study-mandated procedure. Are the trial subjects under 18? yes Number of subjects for this age range: 64 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible bosentan tablet 2. Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy 3. Pregnancy 4. AST and/or ALT values > 3 times the upper limit of normal range (ULN) 5. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C 6. Premature and permanent study drug discontinuation during the FUTURE 3 core study (AC-052-373) 7. Any major violation of the FUTURE 3 core study (AC-052-373) protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension (PAH).;Secondary Objective: There is no secondary objective;Primary end point(s): No primary endpoint has been defined for this open-label, exploratory extension study ;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: To evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension (PAH).;Secondary Objective: There is no secondary objective;Primary end point(s): No primary endpoint has been defined for this open-label, exploratory extension study ;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, 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