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

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: ACT-385781A (Actelion Epoprostenol) (Drug); Flolan® (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Actelion

Official(s) and/or principal investigator(s):
Wade Benton, PharmD, Study Director, Affiliation: Actelion

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.

Official 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)

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

Primary outcome:

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

Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Signed informed consent prior to initiation of any study-mandated procedure 2. Patients who completed participation in study AC-066A401 3. Patients who have not obtained authorization for commercial ACT-385781 and Flolan at the time of ending participation in study AC-066A401 Exclusion Criteria: 1. Patients who prematurely discontinued study drug in study AC-066A401 2. Patients for whom continued treatment with either ACT-385781 and Flolan is no longer considered appropriate 3. Known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients 4. 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 5. Known concomitant life-threatening disease with a life expectancy < 12 months

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

University of Colorado - Denver, Aurora, Colorado 80045, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

University of Pennsylvania-Penn Presybyterian Medical Center, Philadelphia, Pennsylvania 19104, United States

Vanderbilt Medical Center, Nashville, Tennessee 37232, United States

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Starting date: May 2010
Last updated: November 29, 2012