You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 7, 2024

~ Buy the ORENITRAM (treprostinil diolamine) Drug Profile, 2024 PDF Report in the Report Store ~

CLINICAL TRIALS PROFILE FOR ORENITRAM


✉ Email this page to a colleague

« Back to Dashboard


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NCT02603068 ↗ Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis Withdrawn United Therapeutics Phase 2 2016-02-01 This multicenter, randomized, open-label study will assess the safety and efficacy of oral treprostinil in subjects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
Pulmonary Fibrosis 1
Pulmonary Hypertension 1
Raynaud's Phenomenon 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for orenitram
Intervention Trials
Hypertension 4
Pulmonary Arterial Hypertension 3
Familial Primary Pulmonary Hypertension 2
Hypertension, Pulmonary 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for orenitram

Trials by Country

Trials by Country for orenitram
Location Trials
United States 24
Germany 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for orenitram
Location Trials
California 4
Pennsylvania 3
Georgia 2
Ohio 2
Massachusetts 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for orenitram
Clinical Trial Phase Trials
Completed 3
Recruiting 2
Not yet recruiting 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for orenitram
Sponsor Trials
Industry 8
Other 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.