Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years
Completed
United Therapeutics
Phase 2
2014-12-18
This was a multi-center, open-label, safety, tolerability and pharmacokinetic study of oral
treprostinil in pediatric subjects with stable PAH aged 7 to 17 years who were (1)
transitioning from parenteral Remodulin therapy; (2) transitioning from inhaled prostacyclin
therapy; or (3) not currently receiving prostacyclin therapy.
Assess Efficacy of of Oral Treprostinil in Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon
Recruiting
United Therapeutics
Early Phase 1
2016-05-01
This study represents the first trial to assess the efficacy of oral treprostinil therapy in
patients with symptomatic primary or secondary Raynaud's Phenomenon (RP) resistant to
vasodilatory therapy.
The study will be randomized 1:1 UT-15C to placebo. The design is a crossover study and all
subjects will be randomized to receive oral treprostinil sustained release tablets or
matching placebo for 12 weeks and then crossover for 12 weeks. All subjects will be exposed
for 12 weeks of treatment with oral UT-15C during the study.
Assess Efficacy of of Oral Treprostinil in Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon
Recruiting
Brigham and Women's Hospital
Early Phase 1
2016-05-01
This study represents the first trial to assess the efficacy of oral treprostinil therapy in
patients with symptomatic primary or secondary Raynaud's Phenomenon (RP) resistant to
vasodilatory therapy.
The study will be randomized 1:1 UT-15C to placebo. The design is a crossover study and all
subjects will be randomized to receive oral treprostinil sustained release tablets or
matching placebo for 12 weeks and then crossover for 12 weeks. All subjects will be exposed
for 12 weeks of treatment with oral UT-15C during the study.
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