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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 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01291069
The ClinicalTrials.gov registry entry for NCT01291069 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sugar pill is the first listed.
NCT01291069 reports 0 study locations.
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.
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