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CLINICAL TRIALS PROFILE FOR ORENITRAM

All Clinical Trials for orenitram

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02276872 ↗	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.
NCT02583789 ↗	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.
NCT02583789 ↗	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.
NCT02603068 ↗	Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis	Withdrawn	United Therapeutics	Phase 2	2016-02-01	This multicenter, randomized, open-label study will assess the safety and efficacy of oral treprostinil in subjects diagnosed with pulmonary hypertension associated with pulmonary fibrosis.

Clinical Trial Conditions for orenitram

Condition Name

Condition Name for orenitram
Intervention	Trials
Pulmonary Arterial Hypertension	3
Raynaud's Phenomenon	1
Systemic Sclerosis	1
Calcinosis	1

Condition MeSH

Condition MeSH for orenitram
Intervention	Trials
Hypertension	4
Pulmonary Arterial Hypertension	3
Familial Primary Pulmonary Hypertension	2
Sclerosis	1

Clinical Trial Locations for orenitram

Trials by Country

Trials by Country for orenitram
Location	Trials
United States	24
Germany	1

Trials by US State

Trials by US State for orenitram
Location	Trials
California	4
Pennsylvania	3
Ohio	2
Massachusetts	2
Georgia	2

Clinical Trial Progress for orenitram

Clinical Trial Phase

Clinical Trial Phase for orenitram
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	3
Phase 1	1

Clinical Trial Status

Clinical Trial Status for orenitram
Clinical Trial Phase	Trials
Completed	3
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for orenitram

Sponsor Name

Sponsor Name for orenitram
Sponsor	Trials
United Therapeutics	6
Brigham and Women's Hospital	1
Stanford University	1

Sponsor Type

Sponsor Type for orenitram
Sponsor	Trials
Industry	8
Other	2