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.
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
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