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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR REMODULIN

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Clinical Trials for Remodulin

Trial ID Title Status Sponsor Phase Summary
NCT00058929 A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension Completed United Therapeutics Phase 4 This trial is a study of Remodulin in patients with pulmonary arterial hypertension who have been transitioned from Flolan therapy. The study consists of Screening, Baseline and Treatment Phases. Patients meeting all inclusion/exclusion criteria during the Screening Phase will enter the Baseline Phase, during which baseline exercise capacity, vital signs, and clinical signs and symptoms of the disease will be assessed. After confirmation of all inclusion/exclusion criteria, patients will be assigned to study drug (Remodulin or placebo) and will enter the Treatment Phase. The Treatment Phase begins with a Dose Transition Period, during which patients will begin receiving subcutaneous study drug at a low dose determined by the patient's current dose of Flolan. The study drug dose will be increased gradually while the Flolan dose is decreased gradually over a period of up to 14 days. The dose changes will continue until Flolan therapy has been discontinued and the patient is stable on study drug. Patients who are transitioned off Flolan, who are stable on study drug will be discharged from the clinic, and will continue to receive study drug on an outpatient basis. The patient will return to the clinic at Weeks 4 and 8 for assessments. Patients will remain on study drug for 8 weeks from the first dose of study drug. At Week 8, final assessments will be conducted and the patient will be dismissed from the study. Patients who successfully complete Week 8 assessments may be offered Remodulin therapy or other therapy, at the investigator's discretion.
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.
NCT00067041 Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft Terminated United Therapeutics Phase 2/Phase 3 Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.
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
NCT00445159 UT-15C SR in the Treatment of Critical Limb Ischemia Unknown status Southern Arizona Vascular Institute 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 Remodulin

Condition Name

Condition Name for Remodulin
Intervention Trials
Pulmonary Arterial Hypertension 12
Pulmonary Hypertension 6
Critical Limb Ischemia 2
Peripheral Vascular Disease 2
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Condition MeSH

Condition MeSH for Remodulin
Intervention Trials
Hypertension 19
Familial Primary Pulmonary Hypertension 13
Hypertension, Pulmonary 10
Ischemia 3
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Clinical Trial Locations for Remodulin

Trials by Country

Trials by Country for Remodulin
Location Trials
United States 59
China 2
India 1
Canada 1
United Kingdom 1
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Trials by US State

Trials by US State for Remodulin
Location Trials
California 7
Illinois 5
New York 5
Ohio 5
Pennsylvania 4
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Clinical Trial Progress for Remodulin

Clinical Trial Phase

Clinical Trial Phase for Remodulin
Clinical Trial Phase Trials
Phase 4 11
Phase 3 2
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Remodulin
Clinical Trial Phase Trials
Completed 8
Terminated 7
Not yet recruiting 3
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Clinical Trial Sponsors for Remodulin

Sponsor Name

Sponsor Name for Remodulin
Sponsor Trials
United Therapeutics 20
University of California, Los Angeles 2
CVie Therapeutics Co. Ltd. 2
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Sponsor Type

Sponsor Type for Remodulin
Sponsor Trials
Industry 23
Other 16
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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Cipla
Johnson and Johnson
Covington
Express Scripts
Chinese Patent Office
Fuji
Boehringer Ingelheim

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