Status:
TERMINATED
Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument
Lead Sponsor:
Actelion
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the...
Eligibility Criteria
Inclusion
- Signed informed consent prior to any study-mandated procedure.
- Patients with PAH who completed study AC-055-401
- Women of childbearing potential must:
- Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum pregnancy tests.
- Agree to use two methods of contraception from Visit 1 until 1 month after study drug discontinuation.
Exclusion
- Patients who prematurely discontinued study drug in study AC-055-401
- Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study
- Known hypersensitivity to macitentan or its excipients or drugs of the same class
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01847014
Start Date
September 1 2013
End Date
November 30 2017
Last Update
August 22 2018
Active Locations (2)
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1
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
2
The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States