Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
ConditionSingle Ventricle Heart Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-18
SponsorMezzion Pharma Co. Ltd
About this trial
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.
Eligibility criteria
Qualifiers
Males and females with Fontan physiology who are 12 to less than 19 years of age at enrollment.
Participant consent or parental/guardian consent and participant assent.
Participant fluency in primary language of country in which study is being conducted.
Current antiplatelet or anticoagulant therapy.
Disqualifiers
Height < 132 cm.
Weight < 40 kg.
Hospitalization for acute decompensated heart failure within the last 12 months.
Current intravenous inotropic drugs.
Trial design
Treatments tested in this trial
- Udenafil
- Placebo
Treatment groups
436 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov