MAESTRO-OL: Macitentan in Eisenmenger Syndrome To Restore Exercise Capacity (Open-Label)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Actelion
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01739400
First received: November 29, 2012
Last updated: August 7, 2014
Last verified: August 2014
  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
Eisenmenger Syndrome
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:
  • assessment of the long-term safety and tolerability [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    • Treatment-emergent AEs up to 30 days after study drug discontinuation.
    • AEs leading to premature discontinuation of study drug.
    • Treatment-emergent serious adverse events (SAEs) up to 30 days after study drug discontinuation.
    • Treatment-emergent marked laboratory abnormalities (MLA) of interest up to EOT.
    • Proportion of subjects with treatment-emergent ALT and/or AST 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: June 2016
Estimated Primary Completion Date: May 2016 (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 Name: Macitentan, ACT-064992

  Eligibility

Ages Eligible for Study:   12 Years to 71 Years
Genders Eligible for Study:   Both
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 84 Study Locations
Sponsors and Collaborators
Actelion
  More Information

No publications provided

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: August 7, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Malaysia: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Philippines: Department of Health
Philippines : Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan: Department of Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Vietnam: Ministry of Health

Keywords provided by Actelion:
Eisenmenger Syndrome

Additional relevant MeSH terms:
Eisenmenger Complex
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 21, 2014