NCT02080637|CompletedPhase 2Results
Ambrisentan in Single Ventricle
Safety, Pharmacokinetics (PK) and Hemodynamic Effects of Ambrisentan in Single Ventricle Pediatric Patients
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Sponsor study identifier
interventional
16
1 country
1
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 20, 2017
Actual (reported)Study Completion
August 20, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 20, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 21, 2014
Actual (reported)March 6, 2014
Actual (reported)July 2015
Date type not reportedThis date has not been verified as actual or estimated.
July 20, 2017
Actual (reported)August 20, 2017
Actual (reported)September 12, 2019
Actual (reported)Area Under the Curve for Ambrisentan Plasma Concentration
Plasma samples collected at 0-1,1-6,18-30 and 40-60 hours after administration of the first ambrisentan dose.
0-1,1-6,18-30 and 40-60 hours
Change in Pulmonary Vascular Resistance Index
Hemodynamic data, including Fontan pressures, common atrial pressures and saturations, will be collected at the specified timepoints. Pressures and saturations will be measured from existing monitoring lines. Standard Fick calculations will be used to calculate pulmonary vascular resistance (calculated as trans-pulmonary gradient \[Fontan pressure - atrial pressure\] / pulmonary blood flow \[Qp\]) and reported in Wood Units x m\^2.
baseline to 2 hours post ambrisentan administration
Amount of Chest Tube Drainage Post Fontan Operation
0-96 hours post Fontan
Duration of Chest Tube Drainage Post Fontan Operation
measured for the duration of the post-operative hospitalization or for 30 days, whichever is shorter
Oral ambrisentan 2.5 - 5 mg, single dose, once daily
Oral placebo 2.5 - 5 mg, single dose, once daily
Once daily oral dosing
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Duke Universtiy Hospital
Durham, North Carolina, 27710, United States
Kevin Hill, MD
Duke University
16 participants (actual enrollment reported by the registry).
First Submitted
February 21, 2014
First Posted
March 6, 2014
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension
Contact the study team to confirm eligibility.
Primary Completion
July 20, 2017
Actual (reported)Study Completion
August 20, 2017
Actual (reported)Last Updated
September 12, 2019
Results First Posted
September 12, 2019
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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