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NCT02741115 · ClinicalTrials.gov registry record · Phase 3
Fontan Udenafil Exercise Longitudinal Assessment Trial
A Phase 3 study of Single Ventricle Heart Disease, sponsored by Mezzion Pharma Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT02741115: Completed Phase 3 study of Single Ventricle Heart Disease, sponsored by Mezzion Pharma Co..
NCT02741115 is a Phase 3 study of Single Ventricle Heart Disease that has completed, run by Mezzion Pharma Co.. The registered enrollment target is 400 participants, above the 125-participant average among 4 other Single Ventricle Heart Disease trials with a reported enrollment target (220% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02741115, a Phase 3 study of Single Ventricle Heart Disease, has completed, sponsored by Mezzion Pharma Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 400 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 subjects who have undergone the Fontan procedure.
Primary Outcome
The change in exercise capacity (as measured by peak VO2 at maximum exercise effort) from baseline to 26 weeks
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Udenafil
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Cedars/Sinai Heart Institute - Los Angeles
- Rady Children's Hospital - San Diego
Missouri
- Children's Mercy Hospital Kansas City - Kansas City
- Washington University St. Louis/St.Louis Children's Hospital - St Louis
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hosptial - Columbus
Arizona
- Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital - Phoenix
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Nemours Cardiac Center/Alfred I. duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- Johns Hopkins All Children's Heart Institute - St. Petersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2016-07-22 |
| Est. Completion | 2019-04-30 |
| Phase | Phase 3 |
What the finished NCT02741115 record still lists
NCT02741115 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 125-participant average among 4 other Single Ventricle Heart Disease trials with a reported enrollment target (220% 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.
NCT02741115 names 20 study sites across 16 states, led by California, Missouri, Ohio.
Frequently Asked Questions
What is clinical trial NCT02741115 about?
NCT02741115 is a clinical study titled "Fontan Udenafil Exercise Longitudinal Assessment 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 subjects who have undergone the Fontan procedure.
What is the current status of trial NCT02741115?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2016-07-22. Estimated completion is 2019-04-30.
What conditions does trial NCT02741115 study?
This clinical trial studies the following conditions: Single Ventricle Heart Disease.
What interventions are being tested in trial NCT02741115?
The interventions under investigation include: Placebo (DRUG), Udenafil (DRUG).
Who is sponsoring clinical trial NCT02741115?
This trial is sponsored by Mezzion Pharma Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02741115 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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