An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2

• Conditions: Idiopathic or familial pulmonary arterial hypertension

• Registration Number: EUCTR2005-001967-70-DE
• Lead Sponsor: Actelion Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-30
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

·Signed informed consent by the parents or the legal representatives.

·Patients who completed the FUTURE 1 study.

·Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of FUTURE 1.

·Male or female >= 2 and < 12 years of age at enrollment in FUTURE 2.
Females who are menstruating must have a negative pregnancy test. A reliable method of contraception must be considered, if appropriate.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Intolerance to bosentan despite dose reductions.

·Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy.

·Pregnancy or breast-feeding.

·Known hypersensitivity to bosentan or any of the excipients.

·Premature and permanent study drug discontinuation during FUTURE 1.

Study & Design

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