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

November 29, 2012
April 14, 2014
May 2013
May 2014   (final data collection date for primary outcome measure)
Change from baseline to Week 16 in exercise capacity, as measured by 6MWD [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01743001 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
MAESTRO (Macitentan in Eisenmenger Syndrome To Restore Exercise Capacity)
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.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Eisenmenger Syndrome
  • 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
  • Drug: Matching placebo oral tablet, to be taken once daily.
    Matching placebo oral tablet, to be taken once daily.
    Other Name: Placebo
  • Experimental: Macitentan
    Macitentan 10 mg, oral tablet, to be taken once daily.
    Intervention: Drug: Macitentan 10 mg, oral tablet, to be taken once daily.
  • Placebo Comparator: Placebo
    Matching placebo oral tablet, to be taken once daily.
    Intervention: Drug: Matching placebo oral tablet, to be taken once daily.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
June 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
12 Years to 70 Years
No
Not Provided
United States,   Austria,   Belgium,   Bulgaria,   Canada,   Chile,   Czech Republic,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Malaysia,   Mexico,   Netherlands,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   South Africa,   Spain,   Taiwan,   Turkey,   United Kingdom,   Vietnam
 
NCT01743001
AC-055-305
Yes
Actelion
Actelion
Not Provided
Not Provided
Actelion
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP