MAESTRO (Macitentan in Eisenmenger Syndrome To Restore Exercise Capacity)

This study is currently recruiting participants.
Verified April 2014 by Actelion
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01743001
First received: November 29, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.


Condition Intervention Phase
Eisenmenger Syndrome
Drug: Macitentan 10 mg, oral tablet, to be taken once daily.
Drug: Matching placebo oral tablet, to be taken once daily.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome.

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Change from baseline to Week 16 in exercise capacity, as measured by 6MWD [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to Week 16 in WHO functional class [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 16 in dyspnea (assessed by the Borg dyspnea index) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 16 in quality of life (assessed by the SF-36 questionnaire) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: May 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Macitentan
Macitentan 10 mg, oral tablet, to be taken once daily.
Drug: Macitentan 10 mg, oral tablet, to be taken once daily.
Macitentan 10 mg, oral tablet, to be taken once daily.
Other Name: Macitentan, ACT-064992
Placebo Comparator: Placebo
Matching placebo oral tablet, to be taken once daily.
Drug: Matching placebo oral tablet, to be taken once daily.
Matching placebo oral tablet, to be taken once daily.
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects:

    • not participating in the hemodynamic sub-study: males or females ≥ 12 and ≤ 70 years of age.
    • participating in the hemodynamic sub-study: males or females ≥ 18 and ≤ 70 years of age.
  • Subjects with confirmed ES (European Society of Cardiology [ESC] and the European Respiratory Society [ERS] guidelines):

    • Established by echocardiography as:

      • Isolated ASD > 2 cm in diameter,
      • or isolated VSD > 1 cm in diameter,
      • or presence of both ASD and VSD (with either VSD ≤ 1 cm in diameter and ASD > 2 cm in diameter, or VSD > 1 cm in diameter and ASD ≤ 2 cm in diameter, or VSD > 1 cm in diameter and ASD > 2 cm in diameter),
      • and right to left shunt or bi-directional shunt with prevalent right to left direction.
    • Unoperated, or previously palliated surgically for defects mentioned above (incomplete closure) and including fully repaired patent ductus arteriosus (PDA).
    • Resting peripheral arterial oxygen saturation (SaO2) ≤ 90% and >70% (pulse oximetry, room air).
  • Cardiac catheterization measurements must show the following:

    • mPAP > 25 mmHg,
    • PCWP or LAP or LVED ≤ 15 mmHg,
    • PVR ≥ 800 dyn∙s/cm5 or ≥ 10 Wood units.
  • Subjects with WHO functional class ≥ II.
  • Subjects able to perform the 6MWT with a minimum distance of 50 m and a maximum distance of 450 m.

Exclusion Criteria:

  • PAH not fulfilling the criteria of ES as described in inclusion criteria (e.g., complex cardiac defects, single ventricle, and unrepaired or partially repaired PDA).
  • Known moderate-to-severe restrictive (i.e., TLC < 60% of predicted value) or obstructive lung disease (i.e., FEV1 < 80 % of predicted, with FEV1 / FVC < 70%).
  • Down Syndrome.
  • Treatment with PDE-5 inhibitors or prostanoids within 1 month prior to Randomization.
  • Treatment with ERAs within 1 month prior to Randomization.
  • Subjects who initiated diuretics within 1 week prior to Randomization or subjects whose diuretic treatment has not been stable within 1 week prior to Randomization.
  • Subjects being considered for an organ transplant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743001

  Show 93 Study Locations
Sponsors and Collaborators
Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01743001     History of Changes
Other Study ID Numbers: AC-055-305
Study First Received: November 29, 2012
Last Updated: April 14, 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 Publica 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 April 15, 2014