Trial Outcomes & Findings for Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction (NCT NCT02070991)
NCT ID: NCT02070991
Last Updated: 2019-05-15
Results Overview
The main endpoint is the number of participants who had at least one of the following: A) significant fluid retention, defined as increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload and/or parenteral administration of diuretics. B) Worsening of NYHA functional class from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day
Results posted on
2019-05-15
Participant Flow
Participants were screened from 28 sites across Europe and North America in 11 countries (Austria, Belgium, Canada, Czech Republic, Germany, France, Israel, Italy, Spain, Switzerland, USA).
Of the 88 participants screened 63 were randomized in a 1:1 ratio to macitentan 10 mg (N = 31) or placebo (N = 32).
Participant milestones
| Measure |
Macitentan
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
|
Placebo
Matching placebo to be taken once daily, oral use, film-coated tablet
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
|
Overall Study
COMPLETED
|
28
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Macitentan
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
|
Placebo
Matching placebo to be taken once daily, oral use, film-coated tablet
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The value of 1 patient is missing in the macitentan group.
Baseline characteristics by cohort
| Measure |
Macitentan
n=31 Participants
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
|
Placebo
n=32 Participants
Matching placebo to be taken once daily, oral use, film-coated tablet
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.0 Years
n=31 Participants
|
72.0 Years
n=32 Participants
|
71.0 Years
n=63 Participants
|
|
Age, Customized
18-64 years
|
5 Participants
n=31 Participants
|
3 Participants
n=32 Participants
|
8 Participants
n=63 Participants
|
|
Age, Customized
65-84 years
|
26 Participants
n=31 Participants
|
28 Participants
n=32 Participants
|
54 Participants
n=63 Participants
|
|
Age, Customized
≥ 85 years
|
0 Participants
n=31 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=63 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=31 Participants
|
16 Participants
n=32 Participants
|
41 Participants
n=63 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=31 Participants
|
16 Participants
n=32 Participants
|
22 Participants
n=63 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=31 Participants
|
1 Participants
n=32 Participants
|
2 Participants
n=63 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=31 Participants
|
31 Participants
n=32 Participants
|
61 Participants
n=63 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=63 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=31 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=63 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=31 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=63 Participants
|
|
Race/Ethnicity, Customized
White
|
30 Participants
n=31 Participants
|
30 Participants
n=32 Participants
|
60 Participants
n=63 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=31 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=63 Participants
|
|
Time from Left Ventricular Dysfunction (LVD) diagnosis
|
0.9 years
n=31 Participants
|
1.5 years
n=32 Participants
|
1.3 years
n=63 Participants
|
|
Time from Combined pre- and post-capillary Pulmonary Hypertension (CpcPH) diagnosis
|
0.2 years
n=30 Participants • The value of 1 patient is missing in the macitentan group.
|
0.2 years
n=32 Participants • The value of 1 patient is missing in the macitentan group.
|
0.2 years
n=62 Participants • The value of 1 patient is missing in the macitentan group.
|
|
New York Heart Association (NYHA) Functional Class at baseline
Class I
|
0 Participants
n=31 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=63 Participants
|
|
New York Heart Association (NYHA) Functional Class at baseline
Class II
|
5 Participants
n=31 Participants
|
10 Participants
n=32 Participants
|
15 Participants
n=63 Participants
|
|
New York Heart Association (NYHA) Functional Class at baseline
Class III
|
26 Participants
n=31 Participants
|
22 Participants
n=32 Participants
|
48 Participants
n=63 Participants
|
|
New York Heart Association (NYHA) Functional Class at baseline
Class IV
|
0 Participants
n=31 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=63 Participants
|
|
6-minute walk distance (6MWD) at baseline
|
300.0 meter
n=31 Participants
|
305.0 meter
n=32 Participants
|
300.0 meter
n=63 Participants
|
|
Participants with Atrial Fibrillation at baseline
Yes
|
22 Participants
n=31 Participants
|
24 Participants
n=32 Participants
|
46 Participants
n=63 Participants
|
|
Participants with Atrial Fibrillation at baseline
No
|
9 Participants
n=31 Participants
|
8 Participants
n=32 Participants
|
17 Participants
n=63 Participants
|
|
Participants with Diabetes Mellitus Type II
Yes
|
14 Participants
n=31 Participants
|
13 Participants
n=32 Participants
|
27 Participants
n=63 Participants
|
|
Participants with Diabetes Mellitus Type II
No
|
17 Participants
n=31 Participants
|
19 Participants
n=32 Participants
|
36 Participants
n=63 Participants
|
|
Participants with Right Heart Failure (RHF)
Yes
|
7 Participants
n=31 Participants
|
11 Participants
n=32 Participants
|
18 Participants
n=63 Participants
|
|
Participants with Right Heart Failure (RHF)
No
|
24 Participants
n=31 Participants
|
21 Participants
n=32 Participants
|
45 Participants
n=63 Participants
|
|
Participants with Systemic Hypertension
Yes
|
30 Participants
n=31 Participants
|
27 Participants
n=32 Participants
|
57 Participants
n=63 Participants
|
|
Participants with Systemic Hypertension
No
|
1 Participants
n=31 Participants
|
5 Participants
n=32 Participants
|
6 Participants
n=63 Participants
|
|
Participants with Chronic Kidney Disease (CKD)
Yes
|
8 Participants
n=31 Participants
|
6 Participants
n=32 Participants
|
14 Participants
n=63 Participants
|
|
Participants with Chronic Kidney Disease (CKD)
No
|
23 Participants
n=31 Participants
|
26 Participants
n=32 Participants
|
49 Participants
n=63 Participants
|
|
Left Ventricular Ejection Fraction (LEVF) at baseline as measured by Investigator
< 50%
|
6 Participants
n=31 Participants
|
9 Participants
n=32 Participants
|
15 Participants
n=63 Participants
|
|
Left Ventricular Ejection Fraction (LEVF) at baseline as measured by Investigator
≥ 50%
|
25 Participants
n=31 Participants
|
23 Participants
n=32 Participants
|
48 Participants
n=63 Participants
|
|
Pulmonary Vascular Resistance (PVR) at baseline
|
450.0 dyn*sec/cm^5
n=31 Participants
|
483.5 dyn*sec/cm^5
n=32 Participants
|
462.0 dyn*sec/cm^5
n=63 Participants
|
|
Body Mass Index (BMI) at baseline
|
33.30 kg/m^2
n=31 Participants
|
31.15 kg/m^2
n=32 Participants
|
32.40 kg/m^2
n=63 Participants
|
|
Participants with obesity (BMI > 30 kg/m^2)
Yes
|
20 Participants
n=31 Participants
|
20 Participants
n=32 Participants
|
40 Participants
n=63 Participants
|
|
Participants with obesity (BMI > 30 kg/m^2)
No
|
11 Participants
n=31 Participants
|
12 Participants
n=32 Participants
|
23 Participants
n=63 Participants
|
PRIMARY outcome
Timeframe: From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar dayThe main endpoint is the number of participants who had at least one of the following: A) significant fluid retention, defined as increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload and/or parenteral administration of diuretics. B) Worsening of NYHA functional class from baseline.
Outcome measures
| Measure |
Macitentan
n=31 Participants
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
|
Placebo
n=32 Participants
Matching placebo to be taken once daily, oral use, film-coated tablet
|
|---|---|---|
|
Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment
Total participants with at least one condition
|
7 Participants
|
4 Participants
|
|
Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment
Participants with fluid retention
|
7 Participants
|
3 Participants
|
|
Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment
Participants with worsening in NYHA FC
|
1 Participants
|
2 Participants
|
|
Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment
Participants with both conditions
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From randomization up to end of treatment period (Week 12)Population: The values of 6 patients are missing in both the macitentan and the placebo group.
Outcome measures
| Measure |
Macitentan
n=25 Participants
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
|
Placebo
n=26 Participants
Matching placebo to be taken once daily, oral use, film-coated tablet
|
|---|---|---|
|
NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest
|
91.56 percentage of baseline NT-proBNP
Interval 72.37 to 115.83
|
118.90 percentage of baseline NT-proBNP
Interval 92.53 to 152.78
|
SECONDARY outcome
Timeframe: From randomization up to end of treatment period (Week 12)Population: The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing.
Pulmonary vascular resistance (PVR) was assessed at rest by right heart catheterization (RHC).
Outcome measures
| Measure |
Macitentan
n=20 Participants
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
|
Placebo
n=24 Participants
Matching placebo to be taken once daily, oral use, film-coated tablet
|
|---|---|---|
|
PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest
|
66.31 percentage of baseline PVR
Interval 56.15 to 78.3
|
71.23 percentage of baseline PVR
Interval 51.35 to 98.81
|
SECONDARY outcome
Timeframe: From randomization up to end of treatment period (Week 12)Population: The values of 10 patients in the macitentan group and of 7 patients in the placebo group are missing.
Outcome measures
| Measure |
Macitentan
n=21 Participants
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
|
Placebo
n=25 Participants
Matching placebo to be taken once daily, oral use, film-coated tablet
|
|---|---|---|
|
Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)
mPAP at baseline
|
44.6 mmHg
Interval 40.7 to 48.6
|
45.9 mmHg
Interval 41.7 to 50.1
|
|
Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)
mPAP at Week 12
|
41.1 mmHg
Interval 36.2 to 46.0
|
42.1 mmHg
Interval 37.5 to 46.7
|
|
Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)
Change in mPAP from baseline to Week 12
|
-3.5 mmHg
Interval -6.1 to -0.9
|
-3.8 mmHg
Interval -7.5 to -0.1
|
SECONDARY outcome
Timeframe: From randomization up to end of treatment period (Week 12)Population: The values of 10 patients in the macitentan group and of 7 patients in the placebo group are missing.
Outcome measures
| Measure |
Macitentan
n=21 Participants
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
|
Placebo
n=25 Participants
Matching placebo to be taken once daily, oral use, film-coated tablet
|
|---|---|---|
|
Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)
mRAP at baseline
|
12.1 mmHg
Interval 10.0 to 14.3
|
13.0 mmHg
Interval 11.0 to 14.9
|
|
Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)
mRAP at Week 12
|
11.2 mmHg
Interval 8.7 to 13.8
|
11.3 mmHg
Interval 9.2 to 13.5
|
|
Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)
Change in mRAP from baseline to Week 12
|
-0.9 mmHg
Interval -3.5 to 1.7
|
-1.6 mmHg
Interval -3.3 to 0.0
|
SECONDARY outcome
Timeframe: From randomization up to end of treatment period (Week 12)Population: The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing.
Outcome measures
| Measure |
Macitentan
n=20 Participants
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
|
Placebo
n=24 Participants
Matching placebo to be taken once daily, oral use, film-coated tablet
|
|---|---|---|
|
Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP)
Change in PAWP from baseline to Week 12
|
0.8 mmHg
Interval -2.3 to 3.9
|
1.1 mmHg
Interval -1.6 to 3.8
|
|
Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP)
PAWP at baseline
|
19.1 mmHg
Interval 17.4 to 20.7
|
19.7 mmHg
Interval 18.2 to 21.2
|
|
Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP)
PAWP at Week 12
|
19.9 mmHg
Interval 16.6 to 23.1
|
20.8 mmHg
Interval 17.8 to 23.7
|
SECONDARY outcome
Timeframe: From randomization up to end of treatment period (Week 12)Population: The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing.
Outcome measures
| Measure |
Macitentan
n=20 Participants
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
|
Placebo
n=24 Participants
Matching placebo to be taken once daily, oral use, film-coated tablet
|
|---|---|---|
|
Change From Baseline to Week 12 in Cardiac Index (CI)
CI at baseline
|
2.32 L/min/m^2
Interval 2.02 to 2.61
|
2.33 L/min/m^2
Interval 2.09 to 2.57
|
|
Change From Baseline to Week 12 in Cardiac Index (CI)
CI at Week 12
|
2.69 L/min/m^2
Interval 2.36 to 3.02
|
2.30 L/min/m^2
Interval 2.03 to 2.57
|
|
Change From Baseline to Week 12 in Cardiac Index (CI)
Change in CI from baseline to Week 12
|
0.37 L/min/m^2
Interval 0.14 to 0.6
|
-0.03 L/min/m^2
Interval -0.22 to 0.16
|
SECONDARY outcome
Timeframe: From randomization up to end of treatment period (Week 12)Population: The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing.
Outcome measures
| Measure |
Macitentan
n=20 Participants
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
|
Placebo
n=24 Participants
Matching placebo to be taken once daily, oral use, film-coated tablet
|
|---|---|---|
|
Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG)
DPG at baseline
|
11.8 mmHg
Interval 9.0 to 14.5
|
11.4 mmHg
Interval 9.5 to 13.2
|
|
Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG)
DPG at Week 12
|
7.0 mmHg
Interval 4.2 to 9.8
|
7.0 mmHg
Interval 3.7 to 10.4
|
|
Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG)
Change in DPG from baseline to Week 12
|
-4.8 mmHg
Interval -7.2 to -2.3
|
-4.3 mmHg
Interval -7.5 to -1.1
|
Adverse Events
Macitentan
Serious events: 11 serious events
Other events: 16 other events
Deaths: 2 deaths
Placebo
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Macitentan
n=31 participants at risk
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
|
Placebo
n=32 participants at risk
Matching placebo to be taken once daily, oral use, film-coated tablet
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/31 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
3.1%
1/32 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Cardiac disorders
Cardiac failure acute
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Cardiac disorders
Cardiac failure congestive
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
3.1%
1/32 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Cardiac disorders
Cardiorenal syndrome
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Cardiac disorders
Left ventricular failure
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Cardiac disorders
Right ventricular failure
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
3.1%
1/32 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Cardiac disorders
Ventricular tachycardia
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
General disorders
Oedema peripheral
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
3.1%
1/32 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
General disorders
Sudden death
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Infections and infestations
Pneumonia
|
6.5%
2/31 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Infections and infestations
Respiratory tract infection bacterial
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/31 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
3.1%
1/32 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/31 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
3.1%
1/32 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Vascular disorders
Jugular vein thrombosis
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
Other adverse events
| Measure |
Macitentan
n=31 participants at risk
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
|
Placebo
n=32 participants at risk
Matching placebo to be taken once daily, oral use, film-coated tablet
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
2/31 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
6.2%
2/32 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Cardiac disorders
Mitral valve incompetence
|
6.5%
2/31 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
3/31 • Number of events 3 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
3.1%
1/32 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
6.2%
2/32 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
General disorders
Fatigue
|
0.00%
0/31 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
6.2%
2/32 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
General disorders
Oedema peripheral
|
6.5%
2/31 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
9.4%
3/32 • Number of events 3 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Infections and infestations
Respiratory tract infection
|
6.5%
2/31 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/31 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
6.2%
2/32 • Number of events 3 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/31 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
6.2%
2/32 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Investigations
Haemoglobin decreased
|
6.5%
2/31 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Investigations
Walking distance test abnormal
|
0.00%
0/31 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
6.2%
2/32 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Metabolism and nutrition disorders
Fluid retention
|
6.5%
2/31 • Number of events 3 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.5%
2/31 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
6.5%
2/31 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Nervous system disorders
Dizziness
|
6.5%
2/31 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
0.00%
0/32 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
1/31 • Number of events 1 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
6.2%
2/32 • Number of events 2 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.7%
3/31 • Number of events 4 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
12.5%
4/32 • Number of events 5 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/31 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
6.2%
2/32 • Number of events 3 • From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
|
Additional Information
Clinical Trial Disclosure Desk
Actelion Pharmaceuticals Ltd
Phone: +41 61 565 6565
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any study-related publication written independently by investigators must be submitted to Actelion for review at least 30 days prior to submission for publication or presentation. Upon review, Actelion may provide comments, and may also request alterations and/or deletions for the sole purpose of protecting its confidential information and/or patent rights.
- Publication restrictions are in place
Restriction type: OTHER