This trial is active, not recruiting.

Condition pulmonary arterial hypertension
Treatment treprostinil diethanolamine
Phase phase 3
Sponsor United Therapeutics
Start date May 2006
End date December 2020
Trial size 900 participants
Trial identifier NCT01027949, TDE-PH-304


This study provides, or continues to provide, UT-15C SR (treprostinil diethanolamine) to eligible patients with pulmonary arterial hypertension who have completed protocols TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, TDE-PH-308 studies or any additional UT-15C SR clinical protocols evaluating subjects with PAH. The study assesses the long term safety of UT-15C and the effect of continued treatment with UT-15C on exercise capacity after one year of treatment.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
All open will receive active study drug
treprostinil diethanolamine
Oral sustained release tablet, twice or thrice daily. Open label study with active drug, no other intervention arms.

Primary Outcomes

Continued therapy effect on exercise capacity as assessed by a 6-Minute Walk Test
time frame: Once, after one year of therapy with UT-15C SR.
Long-term safety as assessed by clinical laboratories
time frame: Performed at each study scheduled visit
Long-term safety as assessed by adverse events
time frame: Performed monthly during monthly telephone calls

Eligibility Criteria

Male or female participants at least 12 years old.

Participation in study TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302,TDE-PH-308 or any additional UT-15C SR clinical protocol is required. Subjects must complete all assessments in one of these studies to be eligible.

Additional Information

Official title An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension
Description This is an open-label study. Each subject's visit schedule will allow assessments after defined periods of exposure to UT-15C SR (3, 6, 12, 24 and 36 months total exposure). The study will continue with yearly visits beyond 36 months until either UT-15C SR is approved by the appropriate regulatory authorities or the study is discontinued by the sponsor. Therefore, the actual date of each visit will be determined by the date on which the subject first received UT-15C SR (e.g., the date of study drug initiation in TDE-PH- 301, TDE-PH-302, or TDE-PH-308 for subjects who were randomized to active therapy in those trials,and the date of UT-15C SR initiation in this study for subjects who were randomized to placebo in the previous controlled trial). Note that the TDE-PH-202, TDE-PH-203, TDE-PH-205 studies are open-label design and therefore will follow the regimen for subjects receiving UT-15C SR.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by United Therapeutics.