Udenafil for Single Ventricle Heart Disease

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

Recruiting Phase 3 Interventional Study
Single Ventricle Heart Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
12 – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
436 (estimated)
Sponsor
Mezzion Pharma Co. Ltd · Industry
Who this trial is looking for

This trial is looking for adolescents aged 12 to under 19 who have had the Fontan procedure. Participants will take either udenafil or a placebo to help assess its safety and effectiveness.

Are You a Good Fit for This Trial?
Must be taking Antiplatelet therapyAnticoagulant therapy

You may be able to join if

  • I am 12 to less than 19 years old.
  • I have had the Fontan procedure.
  • I can understand the main language of the study.
  • I have my parent's or guardian's consent and my own agreement.
  • I am currently on antiplatelet or anticoagulant therapy.

You may not be able to join if

  • I am shorter than 132 cm.
  • I weigh less than 40 kg.
  • I was hospitalized for heart failure in the last year.
  • I am receiving intravenous inotropic drugs.
  • I am being evaluated for or listed for heart transplantation.
  • I have had serious liver issues.
  • I have had a heart condition that causes serious blood flow problems.
  • I cannot complete the exercise tests required for the trial.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Males and females with Fontan physiology who are 12 to less than 19 years of age at enrollment. 2. Participant consent or parental/guardian consent and participant assent. 3. Participant fluency in primary language of country in which study is being conducted. 4. Current anti…
Contacts

WG Kim

443.699.6746

wgkim@mezzion.com

CONTACT