Efficacy and Safety of Ambrisentan in Children 8-18yrs
Status:
Terminated
Trial end date:
2013-11-12
Target enrollment:
Participant gender:
Summary
A 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and
efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in
subjects aged 8 years up to 18 years with pulmonary arterial hypertension (PAH). An
additional objective is to determine the ambrisentan population pharmacokinetics in the
paediatric population. The study will include a screening/baseline period and a treatment
period. The treatment period will be 24 weeks or until the subject's clinical condition
deteriorates to the point that alternative/additional treatment is necessary. Patients who
participate in the study and in whom continued treatment with ambrisentan is desired will be
eligible to enrol into a long term follow-up study. The primary comparison will be the safety
and tolerability of the two ambrisentan dose groups (Low vs. High) in the paediatric PAH
population The secondary comparison will be the change from baseline for the efficacy
parameters between the two treatment groups.