ong-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome
- Conditions
- Eisenmenger SyndromeMedDRA version: 18.0Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-004411-31-CZ
- Lead Sponsor
- Actelion Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
Subjects with ES (including those with Down Syndrome [DS]) 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
Subjects who prematurely discontinue double-blind study drug during the AC-055-305 / MAESTRO study due to:
- an adverse event (AE) assessed as related to the use of study drug, or
- elevated liver tests (LTs; related or unrelated to study drug)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome (ES).;Secondary Objective: N/A;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A
- Secondary Outcome Measures
Name Time Method Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A