Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument



Status:Terminated
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:8/24/2018
Start Date:September 1, 2013
End Date:November 30, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

AC-055-402: 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 PAH-SYMPACT Instrument

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 PAH-SYMPACT instrument. The objective is to assess the
long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401
study.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
2
sites
Kentuckiana Pulmonary Associates
Louisville, Kentucky 40202
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Louisville, KY
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The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital
Cincinnati, Ohio 45219
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Cincinnati, OH
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