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

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2012-004411-31-GB
• Date of registration: 12/06/2013
• Prospective Registration: Yes
• Primary sponsor: Actelion Pharmaceuticals Ltd
• Public title: Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome
• Scientific title: 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)
• Date of first enrolment: 25/11/2015
• Target sample size: 220
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004411-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Global Medical Information
• Affiliation: Actelion Pharmaceuticals Ltd

• Name: Global Medical Information
• Affiliation: Actelion Pharmaceuticals Ltd

Key inclusion & exclusion 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:
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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

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

Intervention(s)

Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: macitentan
CAS Number: 441798-33-0
Other descriptive name: MACITENTAN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Secondary Objective: N/A

Main Objective: To assess the long-term safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome (ES).

Primary end point(s): N/A

Timepoint(s) of evaluation of this end point: N/A

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: N/A

Secondary end point(s): N/A

Secondary ID(s)

AC-055-308

2012-004411-31-IT

Source(s) of Monetary Support

Actelion Pharmaceuticals Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 27/07/2018
• Date Completed: 12/01/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-004411-31/results