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 the 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

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/05/002685

Enrollment

Registered

2012-05-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Pulmonary arterial Hypertension

Interventions

Intervention1: Bosentan - oral pediatric dispersible formulation: 2mg/kg b.i.d for 12 months, oral. Control Intervention1: Bosentan - oral pediatric dispersible formulation: 2mg/kg t.i.d for 12 months

oral

Eligibility

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.

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
No primary endpoint has been defined for this open-label, exploratory extension study. This is an exporatory study.Timepoint: 12 months of treatment.	—

Secondary

Measure	Time frame
No primary endpoint has been defined for this open-label, exploratory extension study. This is an exporatory study.Timepoint: 12 months of treatment.	—

Countries

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

Contacts

Public ContactChristo Mannil

Care Hospitals

drkoneti@yahoo.com

Outcome results

None listed

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