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Last Updated: April 19, 2024

CLINICAL TRIALS PROFILE FOR TREPROSTINIL DIOLAMINE


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All Clinical Trials for treprostinil diolamine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01560624 ↗ Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy Completed United Therapeutics Phase 3 2012-06-26 This is an international, multicenter, randomized, double-blind, placebo-controlled, event driven study in subjects with pulmonary arterial hypertension.
NCT01746485 ↗ Three Times Daily Dosing of UT-15C Completed United Therapeutics Phase 1 2012-07-01 To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers
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.
NCT04882774 ↗ Telemonitoring to Treat Group 2 Pulmonary Hypertension Not yet recruiting Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) Phase 2 2022-04-01 This study aims to decrease elevated pressure in the lungs of patients with pulmonary hypertension from left heart with elevated pulmonary vascular resistance by utilizing aggressive fluid management with ReDS Pro System and CardioMEMS device. Participants with persistently elevated pulmonary pressure at Week 16 will begin oral treprostinil in combination with the fluid management plan while those with improved pressures maintain their fluid management plan for an additional 16 weeks.
NCT04882774 ↗ Telemonitoring to Treat Group 2 Pulmonary Hypertension Not yet recruiting Ohio State University Phase 2 2022-04-01 This study aims to decrease elevated pressure in the lungs of patients with pulmonary hypertension from left heart with elevated pulmonary vascular resistance by utilizing aggressive fluid management with ReDS Pro System and CardioMEMS device. Participants with persistently elevated pulmonary pressure at Week 16 will begin oral treprostinil in combination with the fluid management plan while those with improved pressures maintain their fluid management plan for an additional 16 weeks.
NCT04882774 ↗ Telemonitoring to Treat Group 2 Pulmonary Hypertension Not yet recruiting Mardi Gomberg -Maitland Phase 2 2022-04-01 This study aims to decrease elevated pressure in the lungs of patients with pulmonary hypertension from left heart with elevated pulmonary vascular resistance by utilizing aggressive fluid management with ReDS Pro System and CardioMEMS device. Participants with persistently elevated pulmonary pressure at Week 16 will begin oral treprostinil in combination with the fluid management plan while those with improved pressures maintain their fluid management plan for an additional 16 weeks.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for treprostinil diolamine

Condition Name

Condition Name for treprostinil diolamine
Intervention Trials
Pulmonary Arterial Hypertension 1
Pulmonary Hypertension Due to Left Heart Disease 1
Systemic Sclerosis 1
Calcinosis 1
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Condition MeSH

Condition MeSH for treprostinil diolamine
Intervention Trials
Hypertension 2
Scleroderma, Systemic 1
Scleroderma, Diffuse 1
Calcinosis 1
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Clinical Trial Locations for treprostinil diolamine

Trials by Country

Trials by Country for treprostinil diolamine
Location Trials
United States 28
China 9
Germany 8
India 7
France 6
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Trials by US State

Trials by US State for treprostinil diolamine
Location Trials
Texas 2
Ohio 2
California 2
Pennsylvania 2
Massachusetts 1
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Clinical Trial Progress for treprostinil diolamine

Clinical Trial Phase

Clinical Trial Phase for treprostinil diolamine
Clinical Trial Phase Trials
Phase 3 1
Phase 2 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for treprostinil diolamine
Clinical Trial Phase Trials
Completed 3
Not yet recruiting 1
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Clinical Trial Sponsors for treprostinil diolamine

Sponsor Name

Sponsor Name for treprostinil diolamine
Sponsor Trials
United Therapeutics 3
Stanford University 1
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) 1
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Sponsor Type

Sponsor Type for treprostinil diolamine
Sponsor Trials
Other 4
Industry 3
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