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-GB
- Lead Sponsor
- Actelion Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 36
·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
·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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method