CompletedPhase 3

A Extension Study of Udenafil in Adolescents

United States301 participantsStarted 2017-02-06

Plain-language summary

This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease.

Who can participate

Age range12 Years – 18 Years

SexALL

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Inclusion criteria

✓. Males and females with Fontan physiology who participated in the FUEL trial or, if they did not participate in FUEL, those who are 12 to less than 19 years of age at enrollment.
✓. Participant consent or parental/guardian consent and participant assent.
✓. Participant fluent in English, Spanish, or Korean.
✓. Current anti-platelet or anticoagulant therapy.

Exclusion criteria

✕. Height \< 132 cm.
✕. Weight \< 40 kg.
✕. 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 three 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 mm Hg between the regions proximal and distal to the obstruction as measured by either catheterization or echocardiography.
✕. Single lung physiology.

What they're measuring

Treatment-Emergent Adverse Events

Timeframe: 52 Weeks

Trial details

NCT IDNCT03013751

SponsorMezzion Pharma Co. Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-30

Results submitted2025-10-29

View on ClinicalTrials.gov More Functional Single Ventricle Heart Disease trials