Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension

This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed informed consent prior to initiation of any study-mandated procedure
Patients who completed participation in study AC-066A301
Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301

Exclusion criteria

Patients who prematurely discontinued study drug in study AC-066A301
Patients for whom continued treatment with EFI is no longer considered appropriate

Treatment and study plan

Epoprostenol

Drug

Administered by continuous intravenous infusion via a central venous catheter; using an ambulatory infusion pump. The dose and infusion rate of EFI may be adjusted throughout the study in order to balance tolerability and maximum clinical benefit

Primary outcomes

Treatment-emergent Adverse Events

Time frame: On average 2.72 years

Secondary outcomes

Exposure Duration

Time frame: On average 2.72 years

Duration of exposure to EFI

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Collaborators

Chiltern International Ltd.
Effi-Stat

Registry information

Official study title

An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)

Acronym: Epitome2ext

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Nov 11, 2011
Registry last updated: Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed