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NCT02080637 · ClinicalTrials.gov registry record · Phase 2
Ambrisentan in Single Ventricle
A Phase 2 study, sponsored by Kevin Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT02080637 is a Phase 2 study that has completed, run by Kevin Hill. The registered enrollment target is 16 participants.
The verdict
NCT02080637, a Phase 2 study, has completed, sponsored by Kevin Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
Purpose: To evaluate the pharmacokinetics, bioavailability and hemodynamic efficacy of ambrisentan after Fontan surgical palliation of single ventricle heart defects. Study activities and population group: Children undergoing Fontan surgical palliation for single ventricle defects will be eligible for the study. Up to 20 subjects will be enrolled (16 ambrisentan, 4 placebo) and will receive 3 days (3 doses) of ambrisentan starting on post-operative day #1 upon returning from the operating room. Ambrisentan plasma levels will be obtained at specified time points during treatment. Post-operative monitoring lines will be used to measure effects of ambrisentan on hemodynamics and pulmonary / systemic endothelial function.
Interventions
- OTHER Placebo
- DRUG Ambrisentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-07 |
| Est. Completion | 2017-08-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02080637
The ClinicalTrials.gov registry entry for NCT02080637 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kevin Hill, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02080637 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02080637 about?
NCT02080637 is a clinical study titled "Ambrisentan in Single Ventricle". Purpose: To evaluate the pharmacokinetics, bioavailability and hemodynamic efficacy of ambrisentan after Fontan surgical palliation of single ventricle heart defects. Study activities and population group: Children undergoing Fontan surgical palliation for single ventricle defects will be eligible ...
What is the current status of trial NCT02080637?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2015-07. Estimated completion is 2017-08-20.
What interventions are being tested in trial NCT02080637?
The interventions under investigation include: Placebo (OTHER), Ambrisentan (DRUG).
Who is sponsoring clinical trial NCT02080637?
This trial is sponsored by Kevin Hill, which has 2 total clinical trials registered on ClinicalTrials.gov.
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