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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR TREPROSTINIL

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Clinical Trials for Treprostinil

Trial ID Title Status Sponsor Phase Summary
NCT00060996 Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures Terminated United Therapeutics Phase 3 The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to determine the effect of Remodulin on wound healing and treadmill walk distance.
NCT00147199 Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH) Completed United Therapeutics Phase 3 This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.
NCT00325403 FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH) Completed United Therapeutics Phase 3 This study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12. Patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
NCT00325442 FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH) Completed United Therapeutics Phase 3 This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16. Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
NCT00373360 Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin Completed United Therapeutics Phase 4 The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.
NCT00439946 Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH Terminated United Therapeutics Phase 4 The purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to be mixed daily and is stable at room temperature, so there is no need for ice packs. In addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every 8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a smaller and lighter medication pump called the Crono Five infusion pump. This study will also assess the effect that changing to Remodulin will have on treatment satisfaction and patient quality of life.
NCT00445159 UT-15C SR in the Treatment of Critical Limb Ischemia Unknown status Southern Illinois University Phase 2 This study will evaluate UT-15C sustained release tablets in subjects experiencing ischemic lower limb rest pain related to advanced peripheral arterial disease. Rest pain is one of the primary management issues of severe arterial occlusive disease and may lead to amputation when the pain becomes intolerable and unresponsive to narcotic analgesia. Rest pain also impacts the quality of sleep and mobility with frequent interruptions in sleep and decreased mobility. Treprostinil sodium (Remodulin®) has been studies in several small open-label studies and has been shown to be safe as well as an effective agent for ischemic rest pain when given by subcutaneous or intravenous delivery. However, these forms of administration have patient convenience limitations, including the need for an infusion device and associated pain at the site of infusion with subcutaneous delivery. UT-15C may allow patients suffering from CLI to benefit from the simplicity of an oral dosage form
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Treprostinil

Condition Name

Condition Name for Treprostinil
Intervention Trials
Pulmonary Arterial Hypertension 33
Pulmonary Hypertension 17
Hypertension, Pulmonary 5
Systemic Sclerosis 4
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Condition MeSH

Condition MeSH for Treprostinil
Intervention Trials
Hypertension 55
Familial Primary Pulmonary Hypertension 37
Hypertension, Pulmonary 28
Scleroderma, Diffuse 6
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Clinical Trial Locations for Treprostinil

Trials by Country

Trials by Country for Treprostinil
Location Trials
United States 457
India 25
Canada 23
France 20
Germany 20
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Trials by US State

Trials by US State for Treprostinil
Location Trials
California 31
Texas 28
New York 24
Pennsylvania 23
Massachusetts 19
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Clinical Trial Progress for Treprostinil

Clinical Trial Phase

Clinical Trial Phase for Treprostinil
Clinical Trial Phase Trials
Phase 4 13
Phase 3 21
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Treprostinil
Clinical Trial Phase Trials
Completed 27
Recruiting 18
Terminated 9
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Clinical Trial Sponsors for Treprostinil

Sponsor Name

Sponsor Name for Treprostinil
Sponsor Trials
United Therapeutics 53
University Hospital, Grenoble 4
Lung Biotechnology PBC 3
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Sponsor Type

Sponsor Type for Treprostinil
Sponsor Trials
Industry 62
Other 40
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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Deloitte
Fuji
Healthtrust
McKesson
UBS
Argus Health
Cantor Fitzgerald
Moodys

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