A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.

A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004612-31-PT

Enrollment

105

Registered

2012-05-02

Start date

2012-07-06

Completion date

Unknown

Last updated

2014-06-02

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: 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 CAS Number: 157212-55-0 Current Sponsor code: ACT-050088 Other descriptive name: BOSEN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed informed consent by the parents / legal representatives prior to any study-mandated procedure. 2. Patients who: - were treated for 12 weeks in FUTURE 5 Or - discontinued FUTURE 5 due to PAH-progression. And who performed the Visit 5 assessments of FUTURE 5 according to the FUTURE 5 protocol. 3. Patients who did not prematurely discontinue the study drug due to AEs in FUTURE 5. 4. Females of childbearing potential must have a negative pre treatment serum pregnancy test and must use reliable methods of contraception during the whole treatment period and for 1 month after study drug discontinuation. Are the trial subjects under 18? yes Number of subjects for this age range: 105 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 bosentan dispersible tablet. 2. Pregnancy or breastfeeding. 3. Any AST and/or ALT values > 3 times the upper limit of normal range (ULN) until Visit 5 of FUTURE 5 (inclusive). 4. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C until Visit 5 of FUTURE 5 (inclusive). 5. Any condition that prevents compliance with FUTURE 6 protocol or adherence to therapy.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long-term safety and tolerability of the pediatric formulation of bosentan at a dose of 2 mg/kg b.i.d. in children with pulmonary arterial hypertension (PAH).;Secondary Objective: Not Applicable;Primary end point(s): Not applicable;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

Argentina, Bulgaria, Chile, China, Colombia, Croatia, France, Guatemala, India, Malaysia, Mexico, Netherlands, Peru, Philippines, Portugal, Russian Federation, Serbia, Singapore, South Africa, Taiwan, Ukraine, United States, Vietnam

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