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

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

sites

Gen Hosp Univ Vienna Dept Cardiology

Vienna,

from

Vienna,