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

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 - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004411-31-GB

Enrollment

220

Registered

2013-06-12

Start date

2015-11-25

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eisenmenger Syndrome MedDRA version: 20.0 Level: LLT Classification code 10058554 Term: Eisenmenger's syndrome System Organ Class: 100000164933

Interventions

Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: macit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: N/A;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	—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Austria, Belgium, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States, Vietnam

Contacts

Public ContactGlobal Medical Information

Actelion Pharmaceuticals Ltd

medinfo@actelion.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026