drugset / Trial / NCT05918211

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

NCT05918211

Phase 3 Recruiting 436 enrolled Mezzion Pharma Co. Ltd
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2023-10-30
Primary completion
2025-10-28
Completion
2025-10-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Udenafil Small molecule Oral