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Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
NCT05918211 · View on ClinicalTrials.gov ↗
Study 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 who have had the Fontan procedure.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Udenafil
Study Locations (20)
California
- Children's Hospital of Los Angeles — Los Angeles
- Rady Children's Hospital — San Diego
- UCSF Benioff Children's Hospital — San Francisco
Florida
- UF Health Shands Hospital — Gainesville
- Joe DiMaggio Children's Hospital — Hollywood
- Johns Hopkins All Children's Hospital — St. Petersburg
Georgia
- Children's Healthcare of Atlanta — Atlanta
- Children's Hospital of Georgia — Augusta
Illinois
- Lurie Children's Hospital — Chicago
- University of Chicago — Chicago
Missouri
- Children's Mercy Hospital Kansas City — Kansas City
- Washington University — St Louis
Arizona
- Phoenix Children's Hospital — Phoenix
Arkansas
- Arkansas Children's — Little Rock
Colorado
- Children's Hospital of Colorado — Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 436 participants |
| Start Date | 2023-10-30 |
| Est. Completion | 2025-10-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05918211
The ClinicalTrials.gov registry entry for NCT05918211 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 436 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mezzion Pharma Co., which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Single Ventricle Heart Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05918211 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05918211 about?
NCT05918211 is a clinical study titled "Fontan Udenafil Exercise Longitudinal Assessment Trial - 2". 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.
What is the current status of trial NCT05918211?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 436 participants. The study started on 2023-10-30. Estimated completion is 2025-10-28.
What conditions does trial NCT05918211 study?
This clinical trial studies the following conditions: Single Ventricle Heart Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05918211?
The interventions under investigation include: Placebo (DRUG), Udenafil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05918211?
This trial is sponsored by Mezzion Pharma Co., which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05918211 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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