Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome



Status:Terminated
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:12 - Any
Updated:8/22/2018
Start Date:September 10, 2013
End Date:January 12, 2018

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Long Term, Single-arm, Open-label Extension Study of Protocol AC-055-305 to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome

Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used
for treatment of Eisenmenger syndrome.


Inclusion Criteria:

Subjects with ES (including those with Down Syndrome) having completed the double-blind
AC-055-305 / MAESTRO study as scheduled, i.e., who remained in the double-blind study up to
Week 16 (whether or not they were still taking study drug at the end of this period).

Exclusion Criteria:

Subjects who prematurely discontinue double-blind study drug during the AC-055-305 /
MAESTRO study due to:

- an AE assessed as related to the use of study drug,

- or elevated liver tests (related or unrelated to study drug).
We found this trial at
6
sites
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Las Vegas, Nevada 89109
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4921 Parkview Place
Saint Louis, Missouri 63110
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