The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day
Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation
This is the total number of subjects with at least one adverse event (serious or not serious) whether or not causally related to the study drug and presented cumulatively in the FUTURE 3 and FUTURE 3 Extension study. NOTE: FUTURE 3 extension study was exploratory and no primary efficacy and safety endpoints were defined in the protocol. So, this safety outcome measure was selected and reported as primary endpoint here.
Time frame: Up to 62 weeks in average
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The Children's Hospital - Site 9102
Aurora, Colorado, United States
Children's National Medical Center - Site 9104
Washington D.C., District of Columbia, United States
Columbia University Medical Center Children's Hospital of New York Presbyterian - Site 9101
New York, New York, United States
Royal Children's Hospital Melbourne, Cardiology - Site 5001
Parkville, Australia
The Republican Scientific-Practical Center "Cardiology" - Site 3001
Minsk, Belarus
Cardiovascular Institute and Fuwai Hospital
Beijing, China
Shanghai Children's Medical Center - Site 5102
Shanghai, China
Fakultní nemocnice v Motole, dětské kardiocentrum - Site 3301
Prague, Czechia
Hopital Necker-Enfants Malades, Service de Cardiologie Pédiatrique - Site 2201
Paris, France
CHU de Toulouse - Hôpital des Enfants, Service de Cardiologie Pédiatrique - Site 2202
Toulouse, France
...and 26 more locations