Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401
NCT ID: NCT01105117
Last Updated: 2012-12-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
2 participants
INTERVENTIONAL
2010-05-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
ACT-385781A (Actelion Epoprostenol)
ACT-385781A (Actelion Epoprostenol)
per Prescribing Information
2
Flolan®
Flolan®
per Prescribing Information
Interventions
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ACT-385781A (Actelion Epoprostenol)
per Prescribing Information
Flolan®
per Prescribing Information
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Wade Benton, PharmD
Role: STUDY_DIRECTOR
Actelion
Locations
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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
Countries
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Other Identifiers
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AC-066A402
Identifier Type: -
Identifier Source: org_study_id