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Showing 1–5 of 5 matching trials from the live ClinicalTrials.gov search.
Completed Phase 3 Interventional Results available

A Extension Study of Udenafil in Adolescents

NCT03013751
Conditions
Functional Single Ventricle Heart Disease
Interventions
Udenafil
Drug
Lead sponsor
Mezzion Pharma Co. Ltd
Industry
Eligibility
12 Years to 18 Years
Enrollment
301 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
21
States / cities
Phoenix, Arizona • Los Angeles, California • San Diego, California + 18 more
Completed Phase 1Phase 2 Interventional Results available

Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents

NCT02201342
Conditions
Single Ventricle Heart Disease After Fontan Surgery
Interventions
Udenafil
Drug
Lead sponsor
Mezzion Pharma Co. Ltd
Industry
Eligibility
14 Years to 18 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
5
States / cities
Indianapolis, Indiana • Ann Arbor, Michigan • Cincinnati, Ohio + 2 more
Conditions
Single Ventricle Heart Disease
Interventions
Udenafil, Placebo
Drug
Lead sponsor
Mezzion Pharma Co. Ltd
Industry
Eligibility
12 Years to 18 Years
Enrollment
436 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
37
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Los Angeles, California + 32 more
Completed Phase 3 Interventional Results available

Fontan Udenafil Exercise Longitudinal Assessment Trial

NCT02741115
Conditions
Single Ventricle Heart Disease
Interventions
Udenafil, Placebo
Drug
Lead sponsor
Mezzion Pharma Co. Ltd
Industry
Eligibility
12 Years to 18 Years
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
26
States / cities
Phoenix, Arizona • Los Angeles, California • San Diego, California + 22 more
Conditions
Single Ventricle Heart Disease
Interventions
Udenafil
Drug
Lead sponsor
Mezzion Pharma Co. Ltd
Industry
Eligibility
12 Years and older
Enrollment
88 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
16
States / cities
Aurora, Colorado • Wilmington, Delaware • Washington D.C., District of Columbia + 13 more