The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
142
film-coated tablet; oral use
film-coated tablet; oral use
Change From Baseline in Peak Oxygen Uptake/Consumption (VO2) Up to Week 16
Change from baseline in peak VO2 up to Week 16 was reported.
Time frame: Baseline up to Week 16
Change From Baseline in Peak VO2 Up to Week 52
Change from baseline in peak VO2 up to Week 52 was reported.
Time frame: Baseline up to Week 52
Change From Baseline in Mean Count Per Minute of Daily Physical Activity Measured by Accelerometer (PA-Ac) Up to Week 16
Change from baseline in mean count per minute of daily PA-Ac up to Week 16 was reported. The daily physical activity (counts per min) of the participant was assessed via accelerometer during daytime. The accelerometer was given to the participant at Visit 1, and data was collected for 9 consecutive daily daytime periods after Visit 1 (baseline) to Visit 4 (Week 16).
Time frame: Baseline up to Week 16
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to 56 weeks
Number of Participants With Treatment-emergent Adverse Events (AEs)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to 56 weeks
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University of Alabama at Birmingham
Birmingham, Alabama, United States
UCLA
Los Angeles, California, United States
Massachusetts General Hospital Heart Center
Boston, Massachusetts, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Texas Children's Hospital
Houston, Texas, United States
Providence Medical Research Providence Health Care
Spokane, Washington, United States
Royal Adelaide Hospital
Adelaide, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
The Prince Charles Hospital, Adult Congenital Heart Disease Unit
Chermside, Australia
Royal Children's Hospital
Parkville, Australia
...and 22 more locations
Number of Participants With AEs Leading to Premature Discontinuation of Study Treatment
Number of participants with AEs leading to premature discontinuation of study treatment was reported. AEs leading to premature discontinuation of study treatment were those with action taken with study drug reported as 'permanently discontinued' by the investigator.
Time frame: Up to 56 weeks
Change From Baseline in Systolic and Diastolic Arterial Blood Pressure (BP)
Change from baseline in systolic and diastolic arterial BP at Week 8, Week 16, Week 32 and Week 52 was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Pulse Rate
Change from baseline in pulse rate at Week 8, Week 16, Week 32 and Week 52 was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Oxygen Saturation (SpO2)
Change from baseline in SpO2 was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Body Weight
Change from baseline in body weight was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Values
Number of participants with treatment-emergent markedly laboratory abnormal laboratory values were reported. Abnormal values for platelets (LL \< 75); Lymphocytes (HH \> 4.0); Neutrophils (LL \< 1.5); Prothrombin International Normalized Ratio: HH (greater than and equal to \[\>=\] 1.5 upper limit of normal \[ULN\]), Ratio: HH \>= 2.5 ULN); Bilirubin (HH \>= 2 ULN); Alkaline Phosphatase (HH \> 2.5 ULN); Glomerular Filtration Rate (LL \< 60); Glucose (HH \> 8.9); Triglycerides (HH \> 3.42). Here "HH" refers to values above the normal range, where H stands for "high" and "LL" refers to values below the normal range where L stands for "low".
Time frame: Up to 56 weeks
Change From Baseline in Hemoglobin
Change from baseline in hemoglobin was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Hematocrit
Change from baseline in hematocrit was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Erythrocytes and Reticulocytes
Change from baseline in erythrocytes and reticulocytes at Week 8, Week 16, Week 32 and Week 52 was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelets
Change from baseline in leucocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets at Week 8, Week 16, Week 32 and Week 52 was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Prothrombin Time
Change from baseline in prothrombin time was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Prothrombin International Normalized Ratio
Change from baseline in prothrombin international normalized ratio was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (AP)
Change from baseline in ALT, AST and AP were reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Bilirubin and Direct Bilirubin
Change from baseline in bilirubin and direct bilirubin was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Gamma Glutamyl Transferase
Change from baseline in gamma glutamyl transferase was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Creatinine
Change from baseline in creatinine was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Urea Nitrogen
Change from baseline in urea nitrogen was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Urate
Change from baseline in urate was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Glucose, Cholesterol, Triglycerides, Sodium, Potassium, Chloride and Calcium
Change from baseline in glucose, cholesterol, triglycerides, sodium, potassium, chloride and calcium was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Albumin and Protein
Change from baseline in albumin and protein was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Alpha Fetoprotein
Change from baseline in alpha fetoprotein was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52
Change From Baseline in Cystatin C
Change from baseline in cystatin C was reported.
Time frame: Baseline, Week 8, Week 16, Week 32 and Week 52