Long-term study to evaluate if macitentan is safe, tolerable and efficient 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004411-31-IT

Enrollment

220

Registered

2013-01-11

Start date

2013-02-01

Completion date

Unknown

Last updated

2017-01-31

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

Conditions

Eisenmenger Syndrome MedDRA version: 14.1 Level: PT Classification code 10058554 Term: Eisenmenger's syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Product Name: Macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Macitentan CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Other descriptive nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subjects with ES 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: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

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 function tests (LFTs; related or unrelated to study drug).

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the long-term safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome (ES).;Secondary Objective: NA;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Secondary

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

Countries

Austria, Bulgaria, Canada, Chile, China, Czech Republic, Germany, Greece, Hungary, India, Israel, Italy, Malaysia, Mexico, Philippines, Portugal, Romania, Russian Federation, South Africa, Spain, Taiwan, Turkey, United States, Vietnam

Contacts

Public ContactGlobal medical Information

Actelion Pharmaceuticals Ltd

medinfo_ch@actelion.com.

Outcome results

None listed

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