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TOMORROW - Macitentan for Children with Pulmonary Artery Hypertension - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn how to slow down disease growth in children with pulmonary arterial hypertension with the medicine Macitentan compared to standard of care (SoC).

What is the Condition Being Studied?

Pulmonary Artery Hypertension (PAH)

Who Can Participate in the Study?

Children who:
- Are between the ages of 2-17 years old.
- Have had Pulmonary Artery Hypertension for less than or equal to 5 years.

Age Group
Children

What is Involved?

If you decide that your child will be part of this study, your child:
- Will be randomly assigned (like flipping a coin) to get the study drug, Macitentan, or standard of care.
- Be involved in the study for about 6 years.
- Required to come in for the study visit every 3 months.
- Will have blood draw, echocardiogram, completing questionnaires.   

Study Details

Full Title
A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension
Principal Investigator
Pediatric Cardiologist
Protocol Number
IRB:PRO00076819
NCT:NCT02932410
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698