CLINICAL TRIALS PROFILE FOR EPOPROSTENOL SODIUM

All Clinical Trials for epoprostenol sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00643604 ↗	Rapid Switch From Flolan to Remodulin in the Outpatient Clinic	Terminated	United Therapeutics	Phase 4	2008-03-01	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.
NCT01014156 ↗	Epoprostenol in Pulmonary Embolism	Completed	Free University Medical Center	Phase 4	2004-01-01	You are admitted to hospital because of pulmonary embolism. You are treated with anticoagulants. The investigators know that, despite this treatment, pulmonary embolism can be a threat especially if heart function is compromized. The investigators investigate a well known study drug (epoprostenol) on top of regular treatment with anticoagulants, to see if heart function can be optimized
NCT01105091 ↗	Epoprostenol for Injection in Pulmonary Arterial Hypertension	Completed	Actelion	Phase 4	2010-03-01	This is a prospective, multi-center, open-label, randomized, Phase IV exploratory study comparing safety, tolerability, pharmacokinetics, and effectiveness of ACT-385781A and Flolan (epoprostenol sodium) in patients with pulmonary arterial hypertension who are naïve to injectable prostanoid treatment and in need of such treatment. Approximately 30 patients from 8 U.S. clinical sites will be randomized to receive either ACT-385781A or Flolan (2:1 respectively) for 28 days of treatment.
NCT01105117 ↗	Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401	Completed	Actelion	Phase 4	2010-05-01	This is an open-label, non-randomized extension to study AC-066A401. The study will assess safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a means for continuing treatment after ending participation in study AC-0066A401.
NCT01462565 ↗	Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)	Completed	GlaxoSmithKline	Phase 4	2011-11-01	The purpose of this multicentre, open label, single-arm study in approximately 20 adult patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH).

Clinical Trial Conditions for epoprostenol sodium

Condition Name

Condition Name for epoprostenol sodium
Intervention	Trials
Pulmonary Arterial Hypertension	3
Hypertension, Pulmonary	2
Acute Pulmonary Embolism	1
Pulmonary Hypertension	1

Condition MeSH

Condition MeSH for epoprostenol sodium
Intervention	Trials
Hypertension	6
Pulmonary Arterial Hypertension	5
Familial Primary Pulmonary Hypertension	4
Hypertension, Pulmonary	3

Clinical Trial Locations for epoprostenol sodium

Trials by Country

Trials by Country for epoprostenol sodium
Location	Trials
United States	23
Netherlands	2
Canada	1

Trials by US State

Trials by US State for epoprostenol sodium
Location	Trials
North Carolina	3
California	3
Texas	3
Tennessee	2
Pennsylvania	2

Clinical Trial Progress for epoprostenol sodium

Clinical Trial Phase

Clinical Trial Phase for epoprostenol sodium
Clinical Trial Phase	Trials
Phase 4	7

Clinical Trial Status

Clinical Trial Status for epoprostenol sodium
Clinical Trial Phase	Trials
Completed	5
Terminated	2

Clinical Trial Sponsors for epoprostenol sodium

Sponsor Name

Sponsor Name for epoprostenol sodium
Sponsor	Trials
United Therapeutics	3
Actelion	2
Free University Medical Center	1

Sponsor Type

Sponsor Type for epoprostenol sodium
Sponsor	Trials
Industry	6
Other	1