Clinical Trials Directory

Trials / Completed

CompletedNCT01934582

A Pharmacokinetic Substudy of the TDE-PH-304 Protocol

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
13 (actual)
Sponsor
United Therapeutics · Industry
Sex
All
Age
12 Years – 75 Years
Healthy volunteers
Not accepted

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.

Detailed description

As noted above in "Brief Summary".

Conditions

Interventions

TypeNameDescription
DRUGUT-15C SR
DRUGtreprostinil diethanolamineOpen label study drug.

Timeline

Start date
2013-08-01
Primary completion
2013-11-01
Completion
2013-11-01
First posted
2013-09-04
Last updated
2024-01-03
Results posted
2016-10-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01934582. Inclusion in this directory is not an endorsement.