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 Extensio

• Conditions: Pulmonary Arterial Hypertension; MedDRA version: 13.1Level: LLTClassification code 10064908Term: Associated with (APAH)System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 13.1Level: LLTClassification code 10064909Term: Idiopathic (IPAH)System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 13.1Level: LLTClassification code 10064910Term: Familial (FPAH)System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2010-021793-12-IT
• Lead Sponsor: Actelion Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-16
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Patients who completed the FUTURE 3 core study (AC-052-373) or prematurely discontinued due to PAHprogression, 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:
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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