At a glance
ClinicalIndex Comparison RecordN/ACompleted· 10 enrolled
Drug / intervention
Bosentandrug
Likely dose
Bosentan 62.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Endothelin Blockade in Patients With Single Ventricle Physiology
In Brief
A clinical study evaluating Bosentan for Congenital Heart Disease. Completed, enrolled 10 participants across 1 site.
Detailed Summary
Recent studies have shown beneficial effects of sildenafil in patients with single ventricle congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug with similar effects, will have similar benefit in this patient population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Disease
CountriesUnited States
CollaboratorsActelion
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartMay 2010
Primary CompletionMar 2013
TodayJul 2026
First PostedOct 6, 2009
Enrollment StartMay 1, 2010
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.7 years ago
Interventions
Bosentandrug
Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.