CLINICAL TRIALS PROFILE FOR TREPROSTINIL

All Clinical Trials for TREPROSTINIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00060996 ↗	Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures	Terminated	United Therapeutics	Phase 3	2003-02-01	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	2005-06-01	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	2006-10-01	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	2006-10-01	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	2006-09-01	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	2007-02-01	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.

Clinical Trial Conditions for TREPROSTINIL

Condition Name

Condition Name for TREPROSTINIL
Intervention	Trials
Pulmonary Arterial Hypertension	44
Pulmonary Hypertension	21
Interstitial Lung Disease	10
Hypertension, Pulmonary	5

Condition MeSH

Condition MeSH for TREPROSTINIL
Intervention	Trials
Hypertension	73
Pulmonary Arterial Hypertension	52
Familial Primary Pulmonary Hypertension	48
Hypertension, Pulmonary	36

Clinical Trial Locations for TREPROSTINIL

Trials by Country

Trials by Country for TREPROSTINIL
Location	Trials
United States	654
Canada	26
India	25
Germany	24
France	23

Trials by US State

Trials by US State for TREPROSTINIL
Location	Trials
California	38
Texas	37
Pennsylvania	32
Ohio	29
New York	29

Clinical Trial Progress for TREPROSTINIL

Clinical Trial Phase

Clinical Trial Phase for TREPROSTINIL
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	28
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for TREPROSTINIL
Clinical Trial Phase	Trials
Completed	50
Terminated	16
Recruiting	13

Clinical Trial Sponsors for TREPROSTINIL

Sponsor Name

Sponsor Name for TREPROSTINIL
Sponsor	Trials
United Therapeutics	65
Lung Biotechnology PBC	6
Insmed Incorporated	6

Sponsor Type

Sponsor Type for TREPROSTINIL
Sponsor	Trials
Industry	91
Other	55