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Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

Join our study to explore Udenafil's impact on Fontan patients.

Recruiting
12-18 years
All
Phase 3

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2 is a study for adolescents aged 12 to 18 who have undergone the Fontan procedure, a heart surgery. The study tests udenafil, a medication that helps blood flow better, against a placebo, or fake pill. Udenafil is a type of drug that stops a chemical called PDE5, which can help improve blood circulation.

The study lasts 26 weeks (about 6 months) and involves several centers. It is "double-blinded," meaning neither the doctors nor the participants know who gets udenafil or the placebo. They measure something called VO2, which is how much oxygen your body uses during exercise, to see if udenafil helps.

Participants must be able to speak the local language and be on blood-thinning medication. They cannot join if they have certain health problems, like severe heart or lung issues, or if they’ve used similar drugs recently. Girls cannot be pregnant during the study.

  • The study takes 26 weeks and involves multiple visits.
  • Participants must be on blood-thinning medicine.
  • Some people with specific health conditions cannot join.
Study details
    Single Ventricle Heart Disease

NCT05918211

Mezzion Pharma Co. Ltd

15 March 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.

How long does a clinical trial take place?

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

Do I get compensated for taking part in clinical trials?

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

How safe are clinical trials?

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