Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome (MAESTRO-OL)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Actelion Identifier:
First received: November 29, 2012
Last updated: December 21, 2016
Last verified: December 2016
Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.

Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Macitentan 10 mg tablet, once daily.
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Actelion:

Primary Outcome Measures:
  • (Serious) treatment-emergent adverse events (AEs) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Treatment-emergent (serious) AEs up to 30 days after study drug discontinuation

  • Treatment-emergent marked laboratory abnormalities (MLAs) [ Time Frame: up to EOT ] [ Designated as safety issue: Yes ]
    Treatment-emergent marked laboratory abnormalities (MLA) of interest up to EOT

  • Proportion of subjects with treatment-emergent ALT and/or AST abnormality [ Time Frame: up to EOT ] [ Designated as safety issue: Yes ]
    Proportion of subjects with treatment-emergent ALT and/orAST abnormality (> 3 and ≤ 5 x ULN; > 5 and ≤ 8 x ULN;> 8 x ULN) associated or not with total bilirubin ≥ 2 x ULN, up to EOT.

Estimated Enrollment: 220
Study Start Date: September 2013
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Macitentan
Macitentan 10 mg tablet, once daily.
Drug: Macitentan 10 mg tablet, once daily.
Macitentan 10 mg tablet, once daily.
Other Names:
  • Macitentan
  • ACT-064992


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01739400

  Show 51 Study Locations
Sponsors and Collaborators
  More Information

Responsible Party: Actelion Identifier: NCT01739400     History of Changes
Other Study ID Numbers: AC-055-308 
Study First Received: November 29, 2012
Last Updated: December 21, 2016
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration
Chile: Instituto de Salud Pública de Chile
Vietnam: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Germany: Federal Institute for Drugs and Medical Devices
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Malaysia: Ministry of Health
Philippines: Department of Health
South Africa: Medicines Control Council
Hungary: National Institute of Pharmacy
Austria: Austrian Medicines and Medical Devices Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Mexico: Federal Commission for Protection Against Health Risks
Israel: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Medicines Agency
Bulgaria: Bulgarian Drug Agency
Taiwan: Department of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Portugal: National Pharmacy and Medicines Institute
Philippines : Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
India: Drugs Controller General of India
Canada: Health Canada
Turkey: Ministry of Health

Keywords provided by Actelion:
Eisenmenger Syndrome
exercise capacity

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Eisenmenger Complex
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists processed this record on January 17, 2017