Clinical Trial: Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional




Official Title: A Phase I/II Dose Escalation Trial of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation

Brief Summary: To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular performance, and vascular function.