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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: July 12, 2017
Last verified: July 2017
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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    Treatment-emergent (serious) AEs up to 30 days after study drug discontinuation

  • Treatment-emergent marked laboratory abnormalities (MLAs) [ Time Frame: up to EOT ]
    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 ]
    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
Actual Study Start Date: September 1, 2013
Estimated Study Completion Date: August 30, 2018
Estimated Primary Completion Date: July 31, 2018 (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)
Sexes 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
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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: July 12, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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 August 18, 2017