CompletedPhase 3

Fontan Udenafil Exercise Longitudinal Assessment Trial

United States400 participantsStarted 2016-07-22

Plain-language 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 subjects who have undergone the Fontan procedure.

Who can participate

Age range12 Years – 18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Weight \< 40 kg
✕. Height \< 132 cm.
✕. Hospitalization for acute decompensated heart failure within the last 12 months.
✕. Current intravenous inotropic drugs.
✕. Undergoing evaluation for heart transplantation or listed for transplantation.
✕. Diagnosis of active protein losing enteropathy or plastic bronchitis within the last 3 years, or a history of liver cirrhosis.
✕. Known Fontan baffle obstruction, branch pulmonary artery stenosis, or pulmonary vein stenosis resulting in a mean gradient of \> 4 mmHg between the regions proximal and distal to the obstruction as measured by either catheterization or echocardiography, obtained prior to screening for the trial.
✕. Single lung physiology with greater than 80% flow to one lung.

What they're measuring

Change in Maximal VO2 From Baseline to Week 26 Using Last Observation Carried Forward (LOCF)

Timeframe: Baseline to 26 Weeks

Trial details

NCT IDNCT02741115

SponsorMezzion Pharma Co. Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-27

Results submitted2023-12-23

View on ClinicalTrials.gov More Single Ventricle Heart Disease trials