Clinical trial NCT01105117: Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension
PAH
EPITOME-1
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2010-04-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication
measure: Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths
timeFrame: Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California - San Diego
state: California
city: Aurora
country: United States
facility: University of Colorado - Denver
state: Colorado
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania-Penn Presybyterian Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Actelion
name: Wade Benton, PharmD
role: STUDY_DIRECTOR
References: