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Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401

2014-08-27 03:14:33 | BioPortfolio

Summary

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pulmonary Arterial Hypertension

Intervention

ACT-385781A (Actelion Epoprostenol), Flolan®

Location

University of California - San Diego
La Jolla
California
United States
92037

Status

Enrolling by invitation

Source

Actelion

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:33-0400

Clinical Trials [2438 Associated Clinical Trials listed on BioPortfolio]

Safety, Efficacy and Treatment Satisfaction in Patients With Pulmonary Arterial Hypertension Rapidly Switched From Epoprostenol to Remodulin

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 R...

Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension

OBJECTIVES: I. Provide epoprostenol (Flolan, prostaglandin I2) by chronic infusion to patients with severe primary pulmonary hypertension for whom no alternative therapy is available. ...

Sorafenib Study: Dosing in Patients With Pulmonary Arterial Hypertension (PAH)

The purpose of this study is to assess the safety and tolerability of sorafenib in patients with PAH already on existing therapy with a prostacyclin [epoprostenol (Flolan)], treprostinil (...

Rapid Switch From Flolan to Remodulin in the Outpatient Clinic

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 R...

A Study of Nebulized Epoprostenol (FLOLAN) and Phenylephrine on Arterial Oxygenation During One Lung Ventilation (OLV)

This is a pilot study of a new use of Epoprostenol via inhalation (Epoprostenol is approved for intravenous use). The purpose of this study is to administered inhaled Epoprostenol and intr...

PubMed Articles [5020 Associated PubMed Articles listed on BioPortfolio]

Investigation of safety and efficacy of the new more thermostable formulation of Flolan (epoprostenol) in Japanese patients with pulmonary arterial hypertension (PAH)-An open-label, single-arm study.

This study was conducted to evaluate the safety and efficacy of a new more thermostable Flolan (epoprostenol) solution prepared with the reformulated pH 12.0 diluent in Japanese patients with pulmonar...

EXPRESS: Epoprostenol discontinuation in patients with pulmonary arterial hypertension: a complex medical and social problem.

Clinical and hemodynamic correlates of pulmonary arterial stiffness in incident, untreated patients with idiopathic pulmonary arterial hypertension.

The role of decreased pulmonary arterial (PA) compliance (C), equivalent to increased PA stiffness (1/C) as a critical determinant of right ventricular dysfunction and prognosis has been emphasized in...

The role of platelets in the development and progression of pulmonary arterial hypertension.

Pulmonary arterial hypertension is a multifactorial disease characterized by vasoconstriction, vascular remodeling, inflammation and thrombosis. Although an increasing number of research confirmed tha...

Out of proportion pulmonary hypertension in obstructive lung diseases.

Pulmonary hypertension is common (25-90%) in chronic obstructive pulmonary diseases (COPDs). Severe pulmonary hypertension, however, is quite rare (1-3%). The term 'out of proportion' pulmonary hypert...

Medical and Biotech [MESH] Definitions

A prostaglandin that is a powerful vasodilator and inhibits platelet aggregation. It is biosynthesized enzymatically from PROSTAGLANDIN ENDOPEROXIDES in human vascular tissue. The sodium salt has been also used to treat primary pulmonary hypertension (HYPERTENSION, PULMONARY).

A malformation of the heart in which the embryonic common PULMONARY VEIN was not incorporated into the LEFT ATRIUM leaving behind a perforated fibromuscular membrane bisecting the left atrium, a three-atrium heart. The opening between the two left atrium sections determines the degree of obstruction to pulmonary venous return, pulmonary venous and pulmonary arterial hypertension.

A syndrome characterized by the clinical triad of advanced chronic liver disease, pulmonary vascular dilatations, and reduced arterial oxygenation (HYPOXEMIA) in the absence of intrinsic cardiopulmonary disease. This syndrome is common in the patients with LIVER CIRRHOSIS or portal hypertension (HYPERTENSION, PORTAL).

Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.

Familial or idiopathic hypertension in the PULMONARY CIRCULATION which is not secondary to other disease.

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