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

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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-066A401
Patients who have not obtained authorization for commercial ACT-385781 and Flolan at the time of ending participation in study AC-066A401

Exclusion criteria

Patients who prematurely discontinued study drug in study AC-066A401
Patients for whom continued treatment with either ACT-385781 and Flolan is no longer considered appropriate
Known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients
Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
Known concomitant life-threatening disease with a life expectancy < 12 months

Treatment and study plan

ACT-385781A (Actelion Epoprostenol)

Drug

per Prescribing Information

Flolan®

Drug

per Prescribing Information

Primary outcomes

Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) - Number of Patients With Adverse Events Leading Discontinuation of Study Treatment

Time frame: Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication
Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths

Time frame: Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)

Acronym: EPITOME-1 Ext

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Apr 16, 2010
Registry last updated: Dec 3, 2012

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