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NCT01291069 · ClinicalTrials.gov registry record · Phase 1
Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01291069: Completed Phase 1 study, sponsored by University of Utah.
NCT01291069 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01291069, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This pilot study is aimed at assessing the short-term effects of Tadalafil on the hemodynamic response to exercise and exercise capacity in patients with Fontan circulation. Data regarding effect size and drug tolerability will be used in the design of a randomized multicenter trial. The long-term goal of this investigation is to systematically evaluate the effect of tadalafil therapy on exercise performance, quality of life, and delay of functional deterioration in patients with single ventricle physiology.
Primary Outcome
Short-term treatment with Tadalafil will augment cardiac output and improve exercise capacity (maximal oxygen consumption: VO2 max) in patients with the Fontan circulation. Primary outcome variables include the change in peak exercise capacity (VO2 max), using cycle ergometry after one week of tadalafil therapy
Interventions
- DRUG Sugar pill
- DRUG Tadalafil Citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
What the finished NCT01291069 record still lists
NCT01291069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Sugar pill is the first listed.
NCT01291069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01291069 about?
NCT01291069 is a clinical study titled "Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients". This pilot study is aimed at assessing the short-term effects of Tadalafil on the hemodynamic response to exercise and exercise capacity in patients with Fontan circulation. Data regarding effect size and drug tolerability will be used in the design of a randomized multicenter trial. The long-term g...
What is the current status of trial NCT01291069?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-09. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01291069?
The interventions under investigation include: Sugar pill (DRUG), Tadalafil Citrate (DRUG).
Who is sponsoring clinical trial NCT01291069?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01291069's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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