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NCT05918211 · ClinicalTrials.gov registry record · Phase 3
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
A Phase 3 study of Single Ventricle Heart Disease, sponsored by Mezzion Pharma Co..
- Recruiting
- Registry status
- Phase 3
- Development phase
- 436
- Enrollment target
- 20
- Study locations
NCT05918211: Recruiting Phase 3 study of Single Ventricle Heart Disease, sponsored by Mezzion Pharma Co..
NCT05918211 is a Phase 3 study of Single Ventricle Heart Disease that is actively recruiting participants, run by Mezzion Pharma Co.. The registered enrollment target is 436 participants, above the 116-participant average among 4 other Single Ventricle Heart Disease trials with a reported enrollment target (276% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05918211, a Phase 3 study of Single Ventricle Heart Disease, is actively recruiting participants, sponsored by Mezzion Pharma Co..
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 436 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The change in exercise capacity (as measured by maximal VO2 at maximum exercise effort) from baseline to 26 weeks (or study completion)
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 |
What NCT05918211 shows while recruiting
NCT05918211 is an interventional study that assigns participants to a tested intervention. The registered 436 participants enrollment target is mid-sized for trials with a published cap, above the 116-participant average among 4 other Single Ventricle Heart Disease trials with a reported enrollment target (276% higher).
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.
NCT05918211 names 20 study sites across 13 states, led by California, Florida, Georgia.
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.
What interventions are being tested in trial NCT05918211?
The interventions under investigation include: Placebo (DRUG), Udenafil (DRUG).
Who is sponsoring clinical trial NCT05918211?
This trial is sponsored by Mezzion Pharma Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
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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