At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 13 enrolled
Drug / intervention
UT-15C SR +1 moredrug
Likely dose
Not stated in 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.
A Pharmacokinetic Substudy of Subjects Transitioning From Twice Daily to Three Times Daily Dosing of UT-15C SR (Treprostinil Diethanolamine) in the TDE-PH-304 Protocol
In Brief
A Phase 3 clinical trial evaluating UT-15C SR and treprostinil diethanolamine for Pulmonary Arterial Hypertension. Completed, enrolled 13 participants across 1 site.
Detailed Summary
A sub-study to the TDE-PH-304 protocol to assess the pharmacokinetics of patients transitioning from a twice daily dosing regimen of oral treprostinil to a three times daily dosing regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedSep 2013
Primary CompletionNov 2013
TodayJul 2026
First PostedSep 4, 2013
Enrollment StartAug 1, 2013
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.8 years ago
Interventions
UT-15C SRdrug
treprostinil diethanolaminedrug
Open label study drug.