Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401
Completed · Phase 4
Conditions studied: Pulmonary Arterial Hypertension
In brief
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.
Key facts
- Study ID
- NCT01105117
- Run by
- Actelion
- People needed
- 2
- Starts
- 2010-05-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2012-12-03
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- University of California - San Diego — La Jolla, California, United States
- University of Colorado - Denver — Aurora, Colorado, United States
- Duke University Medical Center — Durham, North Carolina, United States
- University of Pennsylvania-Penn Presybyterian Medical Center — Philadelphia, Pennsylvania, United States
- Vanderbilt Medical Center — Nashville, Tennessee, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.