Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Actelion
Age
2–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
Males or females \>= 2 and \< 12 years of age at enrollment in FUTURE 2 (this study). Females who are menstruating must have a negative pregnancy test. A reliable method of contraception must be considered, if appropriate.
You may not be if
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.
