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
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials