Trial Outcomes & Findings for Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation (NCT NCT02554903)
NCT ID: NCT02554903
Last Updated: 2025-03-30
Results Overview
PVR ratio equals to Week 12 PVR / Baseline PVR. PVR represents the resistance against which the right ventricle needs to pump. PVR was calculated using the following formula: mean pulmonary arterial pressure (mPAP) - pulmonary artery wedge pressure (PAWP)/cardiac output (CO); where mPAP and PAWP were measured at end-expiration and CO was measured in triplicate using the thermodilution method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2025-03-30
Participant Flow
Participant milestones
| Measure |
Macitentan 10 Milligrams (mg)
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
Participants (with PH after LVAD implantation) received matching placebo orally once daily up to Week 12.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Macitentan 10 Milligrams (mg)
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
Participants (with PH after LVAD implantation) received matching placebo orally once daily up to Week 12.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Heart Transplant
|
1
|
2
|
Baseline Characteristics
Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
Baseline characteristics by cohort
| Measure |
Macitentan 10 Milligrams (mg)
n=28 Participants
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
n=29 Participants
Participants (with PH after LVAD implantation) received matching placebo orally once daily up to Week 12.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 8.21 • n=93 Participants
|
58.2 years
STANDARD_DEVIATION 6.98 • n=4 Participants
|
57.4 years
STANDARD_DEVIATION 7.59 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
UNITED STATES
|
28 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: The Full Analysis Set (FAS) included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure. Imputation for missing PAWP value was done using mPAP and CO or with left ventricular end diastolic pressure (LVEDP) values of same visit (if available).
PVR ratio equals to Week 12 PVR / Baseline PVR. PVR represents the resistance against which the right ventricle needs to pump. PVR was calculated using the following formula: mean pulmonary arterial pressure (mPAP) - pulmonary artery wedge pressure (PAWP)/cardiac output (CO); where mPAP and PAWP were measured at end-expiration and CO was measured in triplicate using the thermodilution method.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=27 Participants
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
n=28 Participants
Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.
|
|---|---|---|
|
Pulmonary Vascular Resistance (PVR) Ratio of Week 12 to Baseline
|
0.585 Ratio
Standard Deviation 0.2280
|
0.757 Ratio
Standard Deviation 0.2578
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.
mRAP was collected in the eCRF (electronic case record form). Right atrial pressure (RAP) is the blood pressure in the right atrium of the heart. Change from baseline to Week 12 in mRAP was measured at rest and no correction for multiple testing was applied.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=25 Participants
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
n=25 Participants
Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)
|
0.8 millimeters of mercury (mmHg)
Standard Deviation 5.49
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 4.71
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.
mPAP was collected in the eCRF. The pulmonary artery pressure is a measure of the blood pressure found in the main pulmonary artery. Change from baseline to Week 12 in mPAP was measured at rest and no correction for multiple testing was applied.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=25 Participants
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
n=25 Participants
Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)
|
-3.84 mmHg
Standard Deviation 8.821
|
-3.86 mmHg
Standard Deviation 7.982
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.
PAWP was collected in the eCRF. PAWP is pressure within the pulmonary arterial system when the catheter tip is 'wedged' in the tapering branch of one of the pulmonary arteries. Change from baseline to Week 12 in PAWP was measured at rest and no correction for multiple testing was applied.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=25 Participants
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
n=25 Participants
Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 12 in Pulmonary Arterial Wedge Pressure (PAWP)
|
4.0 mmHg
Standard Deviation 7.86
|
1.0 mmHg
Standard Deviation 4.93
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.
CI was calculated as Cardiac Output (CO)/body surface area (BSA), where CO is Thermodilution Cardiac Output (Liters per minute \[L/min\]) and BSA (m\^2) equals to 0.007184\*weight\^0.425 (kilograms)\*height\^0.725 (centimeter). CI was represented in liters per minute per square meter (L/min/m\^2). Change from baseline to Week 12 in CI was measured at rest and no correction for multiple testing was applied.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=24 Participants
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
n=25 Participants
Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 12 in Cardiac Index (CI)
|
0.093 L/min/m^2
Standard Deviation 0.4680
|
0.041 L/min/m^2
Standard Deviation 0.4576
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The FAS included all participants randomized. Here 'N' (number of participants analyzed) includes all participants who were evaluable for this outcome measure.
TPR was calculated as mPAP/CO where mPAP is mean pulmonary arterial pressure and CO is cardiac output. Change from baseline to Week 12 in TPR was calculated at rest and no correction for multiple testing was applied.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=24 Participants
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
n=25 Participants
Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR)
|
-1.399 Wood Unit
Standard Deviation 2.2515
|
-0.993 Wood Unit
Standard Deviation 2.2596
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.
Mixed venous oxygen saturation measures the end result of oxygen consumption and delivery. Change from baseline to Week 12 in SvO2 was reported and measured at rest and no correction for multiple testing was applied.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=25 Participants
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
n=25 Participants
Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SvO2)
|
4.260 Percentage of SvO2
Standard Deviation 17.1523
|
4.100 Percentage of SvO2
Standard Deviation 8.5202
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.
NT-proBNP levels in the blood are used for diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=22 Participants
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
n=25 Participants
Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 12 in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Levels
|
1325.68 nanograms/Liter (ng/L)
Standard Deviation 1214.719
|
1573.44 nanograms/Liter (ng/L)
Standard Deviation 2327.632
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.
WHO FC is a classification which reflects disease severity based on symptoms. WHO Functional Classification of pulmonary hypertension comprises of Class I (participants with pulmonary hypertension but without resulting limitation of physical activity), II (participants with pulmonary hypertension resulting in slight limitation of physical activity), III (participants with pulmonary hypertension resulting in marked limitation of physical activity) and IV (participants with pulmonary hypertension with inability to carry out any physical activity without symptoms). Change from baseline in WHO FC was reported. WHO FC was categorized as worsening (change greater than \[\>\] 0); improvement (change less than \[\<\] 0); or no change (change equals to \[=\] 0).
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=25 Participants
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
n=25 Participants
Participants (with PH after a LVAD implantation) received matching placebo orally once daily up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 12 in Participants World Health Organization (WHO) Functional Class (FC)
Worsening
|
2 Participants
|
2 Participants
|
|
Change From Baseline to Week 12 in Participants World Health Organization (WHO) Functional Class (FC)
No change
|
13 Participants
|
15 Participants
|
|
Change From Baseline to Week 12 in Participants World Health Organization (WHO) Functional Class (FC)
Improvement
|
10 Participants
|
8 Participants
|
Adverse Events
Macitentan 10 Milligrams (mg)
Serious events: 16 serious events
Other events: 24 other events
Deaths: 1 deaths
Placebo
Serious events: 16 serious events
Other events: 24 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Macitentan 10 Milligrams (mg)
n=28 participants at risk
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
n=29 participants at risk
Participants (with PH after LVAD implantation) received matching placebo orally once daily up to Week 12.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukaemoid Reaction
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial Flutter
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac Failure
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac Failure Acute
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Right Ventricular Failure
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
10.3%
3/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Complication Associated with Device
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Peripheral Swelling
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacterial Infection
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Enterococcal Bacteraemia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Groin Abscess
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Septic Shock
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Streptococcal Infection
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Anticoagulation Drug Level below Therapeutic
|
10.7%
3/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
13.8%
4/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Bilirubin Increased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
International Normalised Ratio Increased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Left Ventricular End-Diastolic Pressure Increased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Liver Function Test Increased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Troponin Increased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Haematoma
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Reversible Ischaemic Neurological Deficit
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Macitentan 10 Milligrams (mg)
n=28 participants at risk
Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12.
|
Placebo
n=29 participants at risk
Participants (with PH after LVAD implantation) received matching placebo orally once daily up to Week 12.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial Flutter
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiogenic Shock
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiorenal Syndrome
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Systolic Dysfunction
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular Tachycardia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Distension
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
13.8%
4/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Catheter Site Haemorrhage
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Chest Discomfort
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Complication Associated with Device
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
10.7%
3/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Feeling Abnormal
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Impaired Healing
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Medical Device Site Discharge
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Medical Device Site Erythema
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Medical Device Site Rash
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Oedema Peripheral
|
14.3%
4/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Peripheral Swelling
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Candida Infection
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Medical Device Site Infection
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Ophthalmic Herpes Simplex
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory Tract Infection
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
10.3%
3/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fractured Sacrum
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Anticoagulation Drug Level above Therapeutic
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Anticoagulation Drug Level below Therapeutic
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Bilirubin Increased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Creatinine Increased
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Potassium Decreased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Sodium Decreased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Triglycerides Increased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Urea Increased
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Uric Acid Increased
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Body Temperature Increased
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Cystatin C Increased
|
10.7%
3/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Echocardiogram Abnormal
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Ejection Fraction Decreased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram St Segment Elevation
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Haematocrit Decreased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin Abnormal
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin Decreased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Heart Rate Irregular
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
N-Terminal Prohormone Brain Natriuretic Peptide Increased
|
14.3%
4/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
13.8%
4/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Protein Total Decreased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Smear Cervix Abnormal
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Troponin Increased
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Venous Pressure Jugular Increased
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Weight Decreased
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Weight Increased
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck Mass
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
14.3%
4/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
24.1%
7/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lumbosacral Radiculopathy
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy Peripheral
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Breast Tenderness
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.7%
3/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Paroxysmal Nocturnal
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Chronic Pigmented Purpura
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity Vasculitis
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palpable Purpura
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
10.3%
3/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Tightness
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
7.1%
2/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Orthostatic Hypotension
|
3.6%
1/28 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Up to 16 weeks
The safety analysis included all participants who received at least one dose of study drug.
|
Additional Information
Medical Affairs Associate Director
Actelion Pharmaceuticals US, Inc
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER