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A Phase III Safety Extension Study of Udenafil in Adolescents with Single Ventricle Physiology after Fontan Palliation (FUEL Extension)


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Major Goals: 1) Determine the safety of udenafil (87.5 mg, twice daily) in an adolescent population with single ventricle congenital heart disease palliated with the Fontan procedure. 2) Evaluate the pharmacodynamic profile of udenafil over a one-year period.
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1 U10 HL068270

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2017-05-01