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NCT02201342 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
A Phase 1 study, sponsored by Mezzion Pharma Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT02201342: Completed Phase 1 study, sponsored by Mezzion Pharma Co..
NCT02201342 is a Phase 1 study that has completed, run by Mezzion Pharma Co.. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02201342, a Phase 1 study, has completed, sponsored by Mezzion Pharma Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular performance, and vascular function.
Primary Outcome
Number of subjects experiencing serious adverse events possibly or probably related to udenafil at doses of 37.5 mg daily, 37.5 mg twice daily, 87.5 mg daily, 87.5 mg twice daily, and 125 mg daily given over a five-day period.
Interventions
- DRUG Udenafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
What the finished NCT02201342 record still lists
NCT02201342 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which Udenafil is the first listed.
NCT02201342 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02201342 about?
NCT02201342 is a clinical study titled "Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents". To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular performance, and vascular function.
What is the current status of trial NCT02201342?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2014-07. Estimated completion is 2015-04.
What interventions are being tested in trial NCT02201342?
The interventions under investigation include: Udenafil (DRUG).
Who is sponsoring clinical trial NCT02201342?
This trial is sponsored by Mezzion Pharma Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02201342's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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