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

• Conditions: Pulmonary arterial hypertension (PAH) in children; MedDRA version: 12.1Level: LLTClassification code 10064908Term: Associated with (APAH); MedDRA version: 12.1Level: LLTClassification code 10064909Term: Idiopathic (IPAH); MedDRA version: 12.1Level: LLTClassification code 10064910Term: Familial (FPAH)

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-14
• Last Update Posted: 8 December 2014

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 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:
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