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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.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01739400
First received: November 29, 2012
Last updated: March 22, 2017
Last verified: March 2017
  Purpose
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: No masking
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: September 1, 2020
Estimated Primary Completion Date: August 1, 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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01739400

  Show 51 Study Locations
Sponsors and Collaborators
Actelion
  More Information

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01739400     History of Changes
Other Study ID Numbers: AC-055-308
Study First Received: November 29, 2012
Last Updated: March 22, 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:
Hypertension
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
Macitentan
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists

ClinicalTrials.gov processed this record on May 22, 2017