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Last Updated: May 27, 2022

CLINICAL TRIALS PROFILE FOR ORENITRAM


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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NCT02603068 ↗ Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis Withdrawn United Therapeutics Phase 2 2016-02-01 This multicenter, randomized, open-label study will assess the safety and efficacy of oral treprostinil in subjects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.
NCT02663895 ↗ Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis Completed United Therapeutics Phase 2 2016-10-01 This is a prospective open-label trial that will enroll 12 patients with systemic sclerosis (SSc) and at least one calcinotic lesion of the hands that is palpable on physical examination and also measureable on hand radiographs, at one single center. Each subject will receive treprostinil orally for 12 months, and follow-up evaluations will be performed every 3 months. Our main objective is to determine whether oral treprostinil is safe, and effective in reducing calcinosis in patients with SSc. We hypothesize that calcinosis is a result of microvascular injury and ischemic damage, and that therefore treprostinil may be beneficial in the treatment of calcinosis in patients with SSc.
NCT02663895 ↗ Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis Completed Stanford University Phase 2 2016-10-01 This is a prospective open-label trial that will enroll 12 patients with systemic sclerosis (SSc) and at least one calcinotic lesion of the hands that is palpable on physical examination and also measureable on hand radiographs, at one single center. Each subject will receive treprostinil orally for 12 months, and follow-up evaluations will be performed every 3 months. Our main objective is to determine whether oral treprostinil is safe, and effective in reducing calcinosis in patients with SSc. We hypothesize that calcinosis is a result of microvascular injury and ischemic damage, and that therefore treprostinil may be beneficial in the treatment of calcinosis in patients with SSc.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Orenitram

Condition Name

Condition Name for Orenitram
Intervention Trials
Pulmonary Arterial Hypertension 3
Calcinosis 1
PAH 1
Pulmonary Fibrosis 1
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Condition MeSH

Condition MeSH for Orenitram
Intervention Trials
Hypertension 4
Pulmonary Arterial Hypertension 3
Familial Primary Pulmonary Hypertension 2
Hypertension, Pulmonary 1
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Clinical Trial Locations for Orenitram

Trials by Country

Trials by Country for Orenitram
Location Trials
United States 24
Germany 1
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Trials by US State

Trials by US State for Orenitram
Location Trials
California 4
Pennsylvania 3
Georgia 2
Ohio 2
Massachusetts 2
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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
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Clinical Trial Status

Clinical Trial Status for Orenitram
Clinical Trial Phase Trials
Completed 3
Recruiting 2
Not yet recruiting 1
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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
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Sponsor Type

Sponsor Type for Orenitram
Sponsor Trials
Industry 8
Other 2
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Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Harvard Business School
Boehringer Ingelheim
McKesson
Baxter

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