Status: Recruiting
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.
Participants needed: 436
Trial details
Phase: Phase 3Age: 12-18Biological sex: AllType: InterventionalSponsor: Mezzion Pharma Co. LtdUpdated: Oct 28, 2025Locations: 40
Eligibility criteria
Males and females with Fontan physiology who are 12 to less than 19 years of age... [+3]
Height < 132 cm. [+29]