Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401
EPITOME-1 Ext
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)
1 other identifier
interventional
2
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2010
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2010
CompletedFirst Posted
Study publicly available on registry
April 16, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
August 23, 2012
CompletedDecember 3, 2012
November 1, 2012
1.2 years
April 15, 2010
July 20, 2012
November 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication
Study Arms (2)
1
ACTIVE COMPARATORACT-385781A (Actelion Epoprostenol)
2
ACTIVE COMPARATORFlolan®
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Actelionlead
Study Sites (7)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wade Benton, PharmD, Director of Medical Affairs
- Organization
- Actelion Pharmaceuticals, US
Study Officials
- STUDY DIRECTOR
Wade Benton, PharmD
Actelion
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2010
First Posted
April 16, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2011
Study Completion
December 1, 2011
Last Updated
December 3, 2012
Results First Posted
August 23, 2012
Record last verified: 2012-11