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Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome (MAESTRO)

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ClinicalTrials.gov Identifier: NCT01743001
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : January 30, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: Macitentan 10 mg
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 71 sites in 26 countries (geographical regions: Asia-Pacific, Eastern Europe, Latin America, North America, Western Europe including Israel and Turkey, and South Africa), of which 55 sites in 21 countries randomized subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The screening period lasted a maximum of 30 days from Visit 1 up to Randomization (Visit 2). A total of 319 subjects were screened and 226 subjects were randomized to macitentan 10 mg and placebo.

Reporting Groups
  Description
Macitentan Subjects receive macitentan 10 mg, oral tablet, to be taken once daily
Placebo Subjects receive macitentan-matching placebo, oral tablet, to be taken once daily

Participant Flow:   Overall Study
    Macitentan   Placebo
STARTED   114   112 
COMPLETED   111   112 
NOT COMPLETED   3   0 
Physician Decision                1                0 
Pregnancy                1                0 
Death                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Macitentan Subjects receive macitentan 10 mg, oral tablet, to be taken once daily
Placebo Subjects receive macitentan-matching placebo, oral tablet, to be taken once daily
Total Total of all reporting groups

Baseline Measures
   Macitentan   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 114   112   226 
Age 
[Units: Years]
Median (Full Range)
 33.0 
 (12 to 82) 
 31.0 
 (13 to 62) 
 32.0 
 (12 to 82) 
Age, Customized 
[Units: Participants]
Count of Participants
     
12 - 17 years   13   2   15 
18 - 55 years   90   105   195 
≥ 56 years   11   5   16 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      82  71.9%      68  60.7%      150  66.4% 
Male      32  28.1%      44  39.3%      76  33.6% 
Region of Enrollment [1] 
[Units: Participants]
Count of Participants
     
Asia-Pacific   47   44   91 
Eastern Europe   25   27   52 
Latin America   19   18   37 
North America   2   5   7 
Western Europe - Israel   21   18   39 
[1] Asia-Pacific includes: China, Malaysia, Philippines, Vietnam; Eastern Europe: Bulgaria, Poland, Romania, Russian Federation, Serbia; Latin America: Chile, Mexico; North America: United States; Western Europe - Israel: Austria, France, Germany, Greece, Israel, Portugal, Spain, Turkey, United Kingdom
Body Mass Index (BMI) 
[Units: Kg/m^2]
Median (Full Range)
 21.15 
 (11.9 to 38.9) 
 21.55 
 (14.5 to 42.2) 
 21.35 
 (11.9 to 42.2) 
WHO functional class [1] [2] 
[Units: Participants]
Count of Participants
     
class I   0   0   0 
class II   69   66   135 
class III   45   46   91 
class IV   0   0   0 
[1] Class I: no symptoms with exercise or at rest. No limitation of activity. Class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing a flight of stairs, grocery shopping, or making the bed). Class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. Class IV: symptoms at rest (e.g. dyspnea and/or fatigue) and inability to carry out any physical activity without symptoms. Patients in class IV manifest signs of right heart failure.
[2] Per protocol patients in WHO functional class I were excluded.


  Outcome Measures

1.  Primary:   Change From Baseline to Week 16 in Exercise Capacity, as Measured by 6-minute Walk Distance (6MWD)   [ Time Frame: From baseline to Week 16 ]

2.  Secondary:   Change From Baseline to Week 16 in WHO Functional Class   [ Time Frame: From baseline to Week 16 ]

3.  Secondary:   Change From Baseline to Week 16 in Dyspnea, Assessed by the Borg Dyspnea Index   [ Time Frame: From baseline to Week 16 ]

4.  Secondary:   Change From Baseline to Week 16 in Quality of Life (QoL), Assessed by the Short Form-36 (SF-36) Questionnaire   [ Time Frame: From baseline to Week 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosure Desk
Organization: Actelion Pharmaceuticals Ltd
e-mail: clinical-trials-disclosure@actelion.com



Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01743001     History of Changes
Other Study ID Numbers: AC-055-305
First Submitted: November 29, 2012
First Posted: December 6, 2012
Results First Submitted: November 28, 2017
Results First Posted: January 30, 2018
Last Update Posted: February 23, 2018