Trial Outcomes & Findings for Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (NCT NCT02021292)
NCT ID: NCT02021292
Last Updated: 2025-03-30
Results Overview
The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
From baseline to Week 16
Results posted on
2025-03-30
Participant Flow
A total of 48 sites in 20 countries screened subjects for recruitment. The study was conducted (i.e., randomized subjects) in a total of 36 sites across 16 countries: Belgium, China, Czech Republic, France, Germany, Hungary, Lithuania, Mexico, Poland, Russia, Thailand, Turkey, South Korea, Switzerland, Ukraine, and the United Kingdom).
Target screening period from Visit 1 up to Randomization was maximum of 30 days, but longer period (up to 60 days) was permitted with pre-approval from Actelion. Total of 186 subjects were screened. Of these, 80 subjects were randomized in 1:1 ratio to macitentan 10 milligram (mg) (n = 40) and placebo (n = 40). All randomized subjects were treated.
Participant milestones
| Measure |
Macitentan
Macitentan 10 mg, oral tablet, to be taken once daily.
|
Placebo
Matching placebo oral tablet, to be taken once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Macitentan
Macitentan 10 mg, oral tablet, to be taken once daily.
|
Placebo
Matching placebo oral tablet, to be taken once daily.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Asia includes: China, South Korea, Thailand; Eastern Europe: Czech Republic, Hungary, Lithuania, Poland, Russia, Ukraine; Latin America: Mexico; Western Europe: Belgium, France, Germany, Switzerland, Turkey and the United Kingdom.
Baseline characteristics by cohort
| Measure |
Macitentan
n=40 Participants
Macitentan 10 mg, oral tablet, to be taken once daily.
|
Placebo
n=40 Participants
Matching placebo oral tablet, to be taken once daily.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
>=65 years
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Age, Continuous
|
60.0 years
n=93 Participants
|
58.0 years
n=4 Participants
|
59.0 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Region of Enrollment
Asia
|
15 Participants
n=93 Participants • Asia includes: China, South Korea, Thailand; Eastern Europe: Czech Republic, Hungary, Lithuania, Poland, Russia, Ukraine; Latin America: Mexico; Western Europe: Belgium, France, Germany, Switzerland, Turkey and the United Kingdom.
|
14 Participants
n=4 Participants • Asia includes: China, South Korea, Thailand; Eastern Europe: Czech Republic, Hungary, Lithuania, Poland, Russia, Ukraine; Latin America: Mexico; Western Europe: Belgium, France, Germany, Switzerland, Turkey and the United Kingdom.
|
29 Participants
n=27 Participants • Asia includes: China, South Korea, Thailand; Eastern Europe: Czech Republic, Hungary, Lithuania, Poland, Russia, Ukraine; Latin America: Mexico; Western Europe: Belgium, France, Germany, Switzerland, Turkey and the United Kingdom.
|
|
Region of Enrollment
Eastern Europe
|
17 Participants
n=93 Participants • Asia includes: China, South Korea, Thailand; Eastern Europe: Czech Republic, Hungary, Lithuania, Poland, Russia, Ukraine; Latin America: Mexico; Western Europe: Belgium, France, Germany, Switzerland, Turkey and the United Kingdom.
|
19 Participants
n=4 Participants • Asia includes: China, South Korea, Thailand; Eastern Europe: Czech Republic, Hungary, Lithuania, Poland, Russia, Ukraine; Latin America: Mexico; Western Europe: Belgium, France, Germany, Switzerland, Turkey and the United Kingdom.
|
36 Participants
n=27 Participants • Asia includes: China, South Korea, Thailand; Eastern Europe: Czech Republic, Hungary, Lithuania, Poland, Russia, Ukraine; Latin America: Mexico; Western Europe: Belgium, France, Germany, Switzerland, Turkey and the United Kingdom.
|
|
Region of Enrollment
Latin America
|
1 Participants
n=93 Participants • Asia includes: China, South Korea, Thailand; Eastern Europe: Czech Republic, Hungary, Lithuania, Poland, Russia, Ukraine; Latin America: Mexico; Western Europe: Belgium, France, Germany, Switzerland, Turkey and the United Kingdom.
|
1 Participants
n=4 Participants • Asia includes: China, South Korea, Thailand; Eastern Europe: Czech Republic, Hungary, Lithuania, Poland, Russia, Ukraine; Latin America: Mexico; Western Europe: Belgium, France, Germany, Switzerland, Turkey and the United Kingdom.
|
2 Participants
n=27 Participants • Asia includes: China, South Korea, Thailand; Eastern Europe: Czech Republic, Hungary, Lithuania, Poland, Russia, Ukraine; Latin America: Mexico; Western Europe: Belgium, France, Germany, Switzerland, Turkey and the United Kingdom.
|
|
Region of Enrollment
Western Europe
|
7 Participants
n=93 Participants • Asia includes: China, South Korea, Thailand; Eastern Europe: Czech Republic, Hungary, Lithuania, Poland, Russia, Ukraine; Latin America: Mexico; Western Europe: Belgium, France, Germany, Switzerland, Turkey and the United Kingdom.
|
6 Participants
n=4 Participants • Asia includes: China, South Korea, Thailand; Eastern Europe: Czech Republic, Hungary, Lithuania, Poland, Russia, Ukraine; Latin America: Mexico; Western Europe: Belgium, France, Germany, Switzerland, Turkey and the United Kingdom.
|
13 Participants
n=27 Participants • Asia includes: China, South Korea, Thailand; Eastern Europe: Czech Republic, Hungary, Lithuania, Poland, Russia, Ukraine; Latin America: Mexico; Western Europe: Belgium, France, Germany, Switzerland, Turkey and the United Kingdom.
|
|
Body Mass Index (BMI)
|
25.7 kg/m^2
n=93 Participants
|
26.0 kg/m^2
n=4 Participants
|
25.7 kg/m^2
n=27 Participants
|
|
Time since diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH)
|
1.7 years
STANDARD_DEVIATION 2.36 • n=93 Participants
|
1.2 years
STANDARD_DEVIATION 1.95 • n=4 Participants
|
1.5 years
STANDARD_DEVIATION 2.16 • n=27 Participants
|
|
6-minute walk distance (6MWD)
|
353.0 meter
STANDARD_DEVIATION 87.90 • n=93 Participants
|
351.2 meter
STANDARD_DEVIATION 73.79 • n=4 Participants
|
352.1 meter
STANDARD_DEVIATION 80.64 • n=27 Participants
|
|
Pulmonary vascular resistance (PVR)
|
929.2 dynes*sec/cm^5
STANDARD_DEVIATION 379.65 • n=93 Participants
|
984.3 dynes*sec/cm^5
STANDARD_DEVIATION 487.06 • n=4 Participants
|
956.8 dynes*sec/cm^5
STANDARD_DEVIATION 434.78 • n=27 Participants
|
|
WHO functional class
class I
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
WHO functional class
class II
|
12 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
WHO functional class
class III
|
28 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
WHO functional class
class IV
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Use of pulmonary arterial hypertension (PAH) medication
NO
|
16 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Use of pulmonary arterial hypertension (PAH) medication
YES
|
24 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 16Population: Full analysis set included all subjects assigned to a study treatment.
The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.
Outcome measures
| Measure |
Macitentan
n=40 Participants
Macitentan 10 mg, oral tablet, to be taken once daily
|
Placebo
n=40 Participants
Matching placebo oral tablet, to be taken once daily
|
|---|---|---|
|
Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest.
|
73.0 percent of baseline PVR
Interval 63.6 to 83.8
|
87.2 percent of baseline PVR
Interval 78.5 to 96.7
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: Full analysis set
The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Outcome measures
| Measure |
Macitentan
n=40 Participants
Macitentan 10 mg, oral tablet, to be taken once daily
|
Placebo
n=40 Participants
Matching placebo oral tablet, to be taken once daily
|
|---|---|---|
|
Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD).
6MWD (m) at baseline
|
353.0 meter
Standard Deviation 87.90
|
351.2 meter
Standard Deviation 73.79
|
|
Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD).
6MWD (m) at Week 24
|
388.0 meter
Standard Deviation 83.31
|
352.2 meter
Standard Deviation 121.29
|
|
Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD).
Change in 6MWD (m) from baseline to Week 24
|
35.0 meter
Standard Deviation 52.52
|
1.0 meter
Standard Deviation 83.24
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: Full analysis set
This outcome measures the difference in the Borg dyspnea index collected at the end of the 6-minute walk test (6MWT) at Week 24 compared to baseline. The Borg dyspnea index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). A decrease in the Borg dyspnea index indicates an improvement.
Outcome measures
| Measure |
Macitentan
n=40 Participants
Macitentan 10 mg, oral tablet, to be taken once daily
|
Placebo
n=40 Participants
Matching placebo oral tablet, to be taken once daily
|
|---|---|---|
|
Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT).
Borg dyspnea index score at baseline
|
4.2 Score on a scale
Standard Deviation 2.52
|
4.2 Score on a scale
Standard Deviation 2.14
|
|
Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT).
Borg dyspnea index score at Week 24
|
4.1 Score on a scale
Standard Deviation 2.52
|
4.4 Score on a scale
Standard Deviation 2.45
|
|
Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT).
Change from baseline to Week 24
|
-0.1 Score on a scale
Standard Deviation 1.86
|
0.3 Score on a scale
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: Full analysis set
WHO functional classes are defined as follows: 1) class I: no symptoms with exercise or at rest. No limitation of activity. 2) class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing a flight of stairs, grocery shopping, or making the bed). 3) class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. 4) class IV: symptoms at rest (such as dyspnea and/or fatigue) and inability to carry out any physical activity without symptoms (e.g. may faint especially while bending over with their heads lowered). Patients in class IV manifest signs of right heart failure. Shifting to a higher class (e.g. from class III to class IV) represents a 'worsening' while shifting to a lower class (e.g. from class III to class II) means an 'improvement'.
Outcome measures
| Measure |
Macitentan
n=40 Participants
Macitentan 10 mg, oral tablet, to be taken once daily
|
Placebo
n=40 Participants
Matching placebo oral tablet, to be taken once daily
|
|---|---|---|
|
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
WHO functional class I at baseline
|
0 Participants
|
0 Participants
|
|
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
WHO functional class II at baseline
|
12 Participants
|
6 Participants
|
|
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
WHO functional class III at baseline
|
28 Participants
|
33 Participants
|
|
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
WHO functional class IV at baseline
|
0 Participants
|
1 Participants
|
|
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
WHO functional class I at Week 24
|
3 Participants
|
1 Participants
|
|
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
WHO functional class II at Week 24
|
15 Participants
|
10 Participants
|
|
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
WHO functional class III at Week 24
|
22 Participants
|
26 Participants
|
|
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
WHO functional class IV at Week 24
|
0 Participants
|
3 Participants
|
|
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
Worsened
|
0 Participants
|
3 Participants
|
|
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
Not worsened - total
|
40 Participants
|
37 Participants
|
|
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
Not Worsened - unchanged
|
31 Participants
|
29 Participants
|
|
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
Not worsened - improved
|
9 Participants
|
8 Participants
|
POST_HOC outcome
Timeframe: From baseline to Week 16Population: Full analysis set for this post-hoc analysis included all subjects assigned to a study treatment with SDV values.
The main analysis of the primary efficacy endpoint of PVR was repeated after the voluntary right heart catheterization source data verification (SDV) and independent medical review of hemodynamic data corrected for 13 subjects reported after the clinical database closure.
Outcome measures
| Measure |
Macitentan
n=40 Participants
Macitentan 10 mg, oral tablet, to be taken once daily
|
Placebo
n=40 Participants
Matching placebo oral tablet, to be taken once daily
|
|---|---|---|
|
Post-hoc Analysis of Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest Including Subjects With Corrected Hemodynamic Values
|
71.5 Percent of baseline PVR
Interval 63.5 to 80.4
|
87.6 Percent of baseline PVR
Interval 79.0 to 97.2
|
POST_HOC outcome
Timeframe: From baseline to Week 16Population: Full analysis set excluding subjects with corrected hemodynamic values.
The main analysis of the primary efficacy endpoint of PVR was repeated which excluded data for 13 subjects with corrected hemodynamic values. The hemodynamic values were reported after the SDV assessment clinical database closure.
Outcome measures
| Measure |
Macitentan
n=33 Participants
Macitentan 10 mg, oral tablet, to be taken once daily
|
Placebo
n=34 Participants
Matching placebo oral tablet, to be taken once daily
|
|---|---|---|
|
Post-hoc Analysis of Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest Excluding Subjects With Corrected Hemodynamic Values
|
68.4 Percent of baseline PVR
Interval 60.3 to 77.5
|
86.1 Percent of baseline PVR
Interval 77.3 to 95.7
|
POST_HOC outcome
Timeframe: From baseline to Week 16Population: Full analysis set excluding subjects with implausible hemodynamic findings.
The main analysis of the primary efficacy endpoint of PVR was repeated which excluded 14 subjects with implausible hemodynamic findings.
Outcome measures
| Measure |
Macitentan
n=32 Participants
Macitentan 10 mg, oral tablet, to be taken once daily
|
Placebo
n=34 Participants
Matching placebo oral tablet, to be taken once daily
|
|---|---|---|
|
Post-hoc Analysis of Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest Excluding Subjects With Implausible Hemodynamic Findings
|
73.9 Percent of baseline PVR
Interval 66.2 to 82.4
|
86.6 Percent of baseline PVR
Interval 77.9 to 96.4
|
POST_HOC outcome
Timeframe: From baseline to Week 24Population: Full analysis set excluding subjects with implausible hemodynamic findings.
The same analysis for the secondary endpoint, 6MWD, is repeated on the full analysis set excluding 14 subjects with implausible hemodynamic findings.
Outcome measures
| Measure |
Macitentan
n=32 Participants
Macitentan 10 mg, oral tablet, to be taken once daily
|
Placebo
n=34 Participants
Matching placebo oral tablet, to be taken once daily
|
|---|---|---|
|
Post-hoc Analysis of Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD) Excluding Subjects With Implausible Hemodynamic Findings
|
37.41 meter
Interval 11.12 to 63.71
|
0.23 meter
Interval -25.28 to 25.74
|
Adverse Events
Macitentan
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 19 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Macitentan
n=40 participants at risk
Macitentan 10 mg, oral tablet, to be taken once daily.
|
Placebo
n=40 participants at risk
Matching placebo oral tablet, to be taken once daily.
|
|---|---|---|
|
Cardiac disorders
Acute right ventricular failure
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
2.5%
1/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Vascular disorders
Embolism
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
General disorders
Oedema peripheral
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Infections and infestations
Sepsis
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Investigations
Weight increased
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
Other adverse events
| Measure |
Macitentan
n=40 participants at risk
Macitentan 10 mg, oral tablet, to be taken once daily.
|
Placebo
n=40 participants at risk
Matching placebo oral tablet, to be taken once daily.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
7.5%
3/40 • Number of events 4 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
7.5%
3/40 • Number of events 3 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
7.5%
3/40 • Number of events 4 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
2/40 • Number of events 3 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
7.5%
3/40 • Number of events 3 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
General disorders
Fatigue
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Investigations
Haemoglobin decreased
|
15.0%
6/40 • Number of events 7 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Vascular disorders
Hypotension
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
10.0%
4/40 • Number of events 4 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
General disorders
Oedema peripheral
|
20.0%
8/40 • Number of events 10 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
10.0%
4/40 • Number of events 4 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
3/40 • Number of events 3 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Infections and infestations
Pharyngitis
|
5.0%
2/40 • Number of events 3 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Nervous system disorders
Syncope
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
7.5%
3/40 • Number of events 3 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
3/40 • Number of events 4 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Infections and infestations
Urinary tract infection
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
2.5%
1/40 • Number of events 1 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/40 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
5.0%
2/40 • Number of events 2 • From double-blind study treatment initiation up to 30 days after study treatment discontinuation
|
Additional Information
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