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Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

Join a study on exercise for Fontan patients with Udenafil.

Recruiting
12-18 years
All
Phase 3

This research study is to see if a drug called *udenafil* helps teenagers who have had a special heart surgery called the Fontan procedure. Udenafil is a medicine that is taken by mouth and works by blocking a specific enzyme, PDE5, to improve blood flow. The study will compare udenafil to a *placebo*, which is a pill that looks like the drug but doesn’t contain any medicine, over 26 weeks (about 6 months).

The main goal is to check if udenafil improves exercise ability, specifically by measuring how much oxygen the body uses during exercise. Participants must be between 12 and 19 years old and have had the Fontan procedure. They should not have serious heart problems or other medical issues that might make participating unsafe.

  • The study lasts for 26 weeks with regular visits for tests and check-ups.
  • No previous udenafil use in the past year is allowed.
  • Participants must not be pregnant and should avoid grapefruit during the study.

If you are interested, you or your guardian need to give permission, and you'll need to be able to attend all required visits and follow the study rules.

Study details
    Single Ventricle Heart Disease

NCT05918211

Mezzion Pharma Co. Ltd

26 April 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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