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Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction (MELODY-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02070991
Recruitment Status : Completed
First Posted : February 25, 2014
Results First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pulmonary Hypertension
Interventions Drug: Macitentan
Drug: Placebo
Enrollment 63
Recruitment Details Participants were screened from 28 sites across Europe and North America in 11 countries (Austria, Belgium, Canada, Czech Republic, Germany, France, Israel, Italy, Spain, Switzerland, USA).
Pre-assignment Details Of the 88 participants screened 63 were randomized in a 1:1 ratio to macitentan 10 mg (N = 31) or placebo (N = 32).
Arm/Group Title Macitentan Placebo
Hide Arm/Group Description Macitentan 10 mg to be taken once daily, oral use, film-coated tablet Matching placebo to be taken once daily, oral use, film-coated tablet
Period Title: Overall Study
Started 31 32
Completed 28 32
Not Completed 3 0
Reason Not Completed
Death             2             0
Withdrawal by Subject             1             0
Arm/Group Title Macitentan Placebo Total
Hide Arm/Group Description Macitentan 10 mg to be taken once daily, oral use, film-coated tablet Matching placebo to be taken once daily, oral use, film-coated tablet Total of all reporting groups
Overall Number of Baseline Participants 31 32 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 31 participants 32 participants 63 participants
70.0
(67.0 to 73.0)
72.0
(68.0 to 75.5)
71.0
(67.0 to 75.0)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
18-64 years
5
  16.1%
3
   9.4%
8
  12.7%
65-84 years
26
  83.9%
28
  87.5%
54
  85.7%
≥ 85 years
0
   0.0%
1
   3.1%
1
   1.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Female
25
  80.6%
16
  50.0%
41
  65.1%
Male
6
  19.4%
16
  50.0%
22
  34.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Hispanic or Latino
1
   3.2%
1
   3.1%
2
   3.2%
Not Hispanic or Latino
30
  96.8%
31
  96.9%
61
  96.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Black or African American
0
   0.0%
1
   3.1%
1
   1.6%
American Indian or Alaska Native
1
   3.2%
0
   0.0%
1
   1.6%
White
30
  96.8%
30
  93.8%
60
  95.2%
Other
0
   0.0%
1
   3.1%
1
   1.6%
Time from Left Ventricular Dysfunction (LVD) diagnosis  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 31 participants 32 participants 63 participants
0.9
(0.1 to 5.4)
1.5
(0.4 to 3.4)
1.3
(0.2 to 4.2)
Time from Combined pre- and post-capillary Pulmonary Hypertension (CpcPH) diagnosis   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 30 participants 32 participants 62 participants
0.2
(0.0 to 1.4)
0.2
(0.0 to 0.5)
0.2
(0.0 to 0.5)
[1]
Measure Analysis Population Description: The value of 1 patient is missing in the macitentan group.
New York Heart Association (NYHA) Functional Class at baseline   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Class I
0
   0.0%
0
   0.0%
0
   0.0%
Class II
5
  16.1%
10
  31.3%
15
  23.8%
Class III
26
  83.9%
22
  68.8%
48
  76.2%
Class IV
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Class I: No symptoms and no limitation in ordinary physical activity, e.g., shortness of breath when walking, climbing stairs etc. Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: Marked limitation in activity due to symptoms, even during less-than ordinary activity, e.g., walking short distances (20–100 m). Comfortable only at rest. Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
6-minute walk distance (6MWD) at baseline  
Median (Inter-Quartile Range)
Unit of measure:  Meter
Number Analyzed 31 participants 32 participants 63 participants
300.0
(216.0 to 435.0)
305.0
(206.5 to 379.5)
300.0
(215.0 to 410.0)
Participants with Atrial Fibrillation at baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Yes
22
  71.0%
24
  75.0%
46
  73.0%
No
9
  29.0%
8
  25.0%
17
  27.0%
Participants with Diabetes Mellitus Type II  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Yes
14
  45.2%
13
  40.6%
27
  42.9%
No
17
  54.8%
19
  59.4%
36
  57.1%
Participants with Right Heart Failure (RHF)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Yes
7
  22.6%
11
  34.4%
18
  28.6%
No
24
  77.4%
21
  65.6%
45
  71.4%
Participants with Systemic Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Yes
30
  96.8%
27
  84.4%
57
  90.5%
No
1
   3.2%
5
  15.6%
6
   9.5%
Participants with Chronic Kidney Disease (CKD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Yes
8
  25.8%
6
  18.8%
14
  22.2%
No
23
  74.2%
26
  81.3%
49
  77.8%
Left Ventricular Ejection Fraction (LEVF) at baseline as measured by Investigator  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
< 50%
6
  19.4%
9
  28.1%
15
  23.8%
≥ 50%
25
  80.6%
23
  71.9%
48
  76.2%
Pulmonary Vascular Resistance (PVR) at baseline  
Median (Inter-Quartile Range)
Unit of measure:  Dyn*sec/cm^5
Number Analyzed 31 participants 32 participants 63 participants
450.0
(296.0 to 590.0)
483.5
(362.0 to 738.5)
462.0
(341.0 to 695.0)
Body Mass Index (BMI) at baseline  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 31 participants 32 participants 63 participants
33.30
(28.80 to 38.30)
31.15
(27.60 to 34.45)
32.40
(28.70 to 36.00)
Participants with obesity (BMI > 30 kg/m^2)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Yes
20
  64.5%
20
  62.5%
40
  63.5%
No
11
  35.5%
12
  37.5%
23
  36.5%
1.Primary Outcome
Title Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment
Hide Description The main endpoint is the number of participants who had at least one of the following: A) significant fluid retention, defined as increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload and/or parenteral administration of diuretics. B) Worsening of NYHA functional class from baseline.
Time Frame From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Macitentan Placebo
Hide Arm/Group Description:
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
Matching placebo to be taken once daily, oral use, film-coated tablet
Overall Number of Participants Analyzed 31 32
Measure Type: Count of Participants
Unit of Measure: Participants
Total participants with at least one condition
7
  22.6%
4
  12.5%
Participants with fluid retention
7
  22.6%
3
   9.4%
Participants with worsening in NYHA FC
1
   3.2%
2
   6.3%
Participants with both conditions
1
   3.2%
1
   3.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Macitentan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3372
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference between maci. and placebo
Estimated Value 10.08
Confidence Interval (2-Sided) 95%
-15.07 to 33.26
Estimation Comments [Not Specified]
2.Secondary Outcome
Title NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest
Hide Description [Not Specified]
Time Frame From randomization up to end of treatment period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The values of 6 patients are missing in both the macitentan and the placebo group.
Arm/Group Title Macitentan Placebo
Hide Arm/Group Description:
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
Matching placebo to be taken once daily, oral use, film-coated tablet
Overall Number of Participants Analyzed 25 26
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage of baseline NT-proBNP
91.56
(72.37 to 115.83)
118.90
(92.53 to 152.78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Macitentan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment effect (ratio of geom. means)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.55 to 1.08
Estimation Comments [Not Specified]
3.Secondary Outcome
Title PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest
Hide Description Pulmonary vascular resistance (PVR) was assessed at rest by right heart catheterization (RHC).
Time Frame From randomization up to end of treatment period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing.
Arm/Group Title Macitentan Placebo
Hide Arm/Group Description:
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
Matching placebo to be taken once daily, oral use, film-coated tablet
Overall Number of Participants Analyzed 20 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage of baseline PVR
66.31
(56.15 to 78.30)
71.23
(51.35 to 98.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Macitentan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment effect (ratio of geom. means)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.64 to 1.36
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)
Hide Description [Not Specified]
Time Frame From randomization up to end of treatment period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The values of 10 patients in the macitentan group and of 7 patients in the placebo group are missing.
Arm/Group Title Macitentan Placebo
Hide Arm/Group Description:
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
Matching placebo to be taken once daily, oral use, film-coated tablet
Overall Number of Participants Analyzed 21 25
Mean (95% Confidence Interval)
Unit of Measure: mmHg
mPAP at baseline
44.6
(40.7 to 48.6)
45.9
(41.7 to 50.1)
mPAP at Week 12
41.1
(36.2 to 46.0)
42.1
(37.5 to 46.7)
Change in mPAP from baseline to Week 12
-3.5
(-6.1 to -0.9)
-3.8
(-7.5 to -0.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Macitentan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment effect (mean change from BL)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-4.3 to 4.9
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)
Hide Description [Not Specified]
Time Frame From randomization up to end of treatment period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The values of 10 patients in the macitentan group and of 7 patients in the placebo group are missing.
Arm/Group Title Macitentan Placebo
Hide Arm/Group Description:
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
Matching placebo to be taken once daily, oral use, film-coated tablet
Overall Number of Participants Analyzed 21 25
Mean (95% Confidence Interval)
Unit of Measure: mmHg
mRAP at baseline
12.1
(10.0 to 14.3)
13.0
(11.0 to 14.9)
mRAP at Week 12
11.2
(8.7 to 13.8)
11.3
(9.2 to 13.5)
Change in mRAP from baseline to Week 12
-0.9
(-3.5 to 1.7)
-1.6
(-3.3 to 0.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Macitentan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment effect (mean change from BL)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-2.2 to 3.6
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP)
Hide Description [Not Specified]
Time Frame From randomization up to end of treatment period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing.
Arm/Group Title Macitentan Placebo
Hide Arm/Group Description:
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
Matching placebo to be taken once daily, oral use, film-coated tablet
Overall Number of Participants Analyzed 20 24
Mean (95% Confidence Interval)
Unit of Measure: mmHg
PAWP at baseline
19.1
(17.4 to 20.7)
19.7
(18.2 to 21.2)
PAWP at Week 12
19.9
(16.6 to 23.1)
20.8
(17.8 to 23.7)
Change in PAWP from baseline to Week 12
0.8
(-2.3 to 3.9)
1.1
(-1.6 to 3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Macitentan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment effect (mean change from BL)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-4.2 to 3.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Week 12 in Cardiac Index (CI)
Hide Description [Not Specified]
Time Frame From randomization up to end of treatment period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing.
Arm/Group Title Macitentan Placebo
Hide Arm/Group Description:
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
Matching placebo to be taken once daily, oral use, film-coated tablet
Overall Number of Participants Analyzed 20 24
Mean (95% Confidence Interval)
Unit of Measure: L/min/m^2
CI at baseline
2.32
(2.02 to 2.61)
2.33
(2.09 to 2.57)
CI at Week 12
2.69
(2.36 to 3.02)
2.30
(2.03 to 2.57)
Change in CI from baseline to Week 12
0.37
(0.14 to 0.60)
-0.03
(-0.22 to 0.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Macitentan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment effect (mean change from BL)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.11 to 0.69
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG)
Hide Description [Not Specified]
Time Frame From randomization up to end of treatment period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing.
Arm/Group Title Macitentan Placebo
Hide Arm/Group Description:
Macitentan 10 mg to be taken once daily, oral use, film-coated tablet
Matching placebo to be taken once daily, oral use, film-coated tablet
Overall Number of Participants Analyzed 20 24
Mean (95% Confidence Interval)
Unit of Measure: mmHg
DPG at baseline
11.8
(9.0 to 14.5)
11.4
(9.5 to 13.2)
DPG at Week 12
7.0
(4.2 to 9.8)
7.0
(3.7 to 10.4)
Change in DPG from baseline to Week 12
-4.8
(-7.2 to -2.3)
-4.3
(-7.5 to -1.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Macitentan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment effect (mean change from BL)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-4.5 to 3.6
Estimation Comments [Not Specified]
Time Frame From study treatment initiation up to 30 days after study treatment discontinuation (Week 12 + 30 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Macitentan Placebo
Hide Arm/Group Description Macitentan 10 mg to be taken once daily, oral use, film-coated tablet Matching placebo to be taken once daily, oral use, film-coated tablet
All-Cause Mortality
Macitentan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/31 (6.45%)      0/32 (0.00%)    
Hide Serious Adverse Events
Macitentan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/31 (35.48%)      6/32 (18.75%)    
Cardiac disorders     
Atrial fibrillation  1  0/31 (0.00%)  0 1/32 (3.13%)  1
Cardiac failure acute  1  1/31 (3.23%)  1 0/32 (0.00%)  0
Cardiac failure congestive  1  1/31 (3.23%)  1 1/32 (3.13%)  1
Cardiorenal syndrome  1  1/31 (3.23%)  1 0/32 (0.00%)  0
Left ventricular failure  1  1/31 (3.23%)  1 0/32 (0.00%)  0
Right ventricular failure  1  1/31 (3.23%)  1 1/32 (3.13%)  1
Ventricular tachycardia  1  1/31 (3.23%)  1 0/32 (0.00%)  0
Gastrointestinal disorders     
Mouth haemorrhage  1  1/31 (3.23%)  1 0/32 (0.00%)  0
General disorders     
Oedema peripheral  1  1/31 (3.23%)  1 1/32 (3.13%)  1
Sudden death  1  1/31 (3.23%)  1 0/32 (0.00%)  0
Infections and infestations     
Pneumonia  1  2/31 (6.45%)  2 0/32 (0.00%)  0
Respiratory tract infection bacterial  1  1/31 (3.23%)  1 0/32 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  0/31 (0.00%)  0 1/32 (3.13%)  2
Metabolism and nutrition disorders     
Hypoglycaemia  1  1/31 (3.23%)  1 0/32 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  0/31 (0.00%)  0 1/32 (3.13%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic respiratory failure  1  1/31 (3.23%)  1 0/32 (0.00%)  0
Pulmonary congestion  1  1/31 (3.23%)  1 0/32 (0.00%)  0
Pulmonary mass  1  1/31 (3.23%)  1 0/32 (0.00%)  0
Pulmonary oedema  1  1/31 (3.23%)  1 0/32 (0.00%)  0
Respiratory failure  1  1/31 (3.23%)  1 0/32 (0.00%)  0
Vascular disorders     
Jugular vein thrombosis  1  1/31 (3.23%)  1 0/32 (0.00%)  0
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Macitentan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/31 (51.61%)      15/32 (46.88%)    
Blood and lymphatic system disorders     
Anaemia  1  2/31 (6.45%)  2 0/32 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  1/31 (3.23%)  1 2/32 (6.25%)  2
Mitral valve incompetence  1  2/31 (6.45%)  2 0/32 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea  1  3/31 (9.68%)  3 1/32 (3.13%)  1
Nausea  1  1/31 (3.23%)  1 2/32 (6.25%)  2
General disorders     
Fatigue  1  0/31 (0.00%)  0 2/32 (6.25%)  2
Oedema peripheral  1  2/31 (6.45%)  2 3/32 (9.38%)  3
Infections and infestations     
Respiratory tract infection  1  2/31 (6.45%)  2 0/32 (0.00%)  0
Urinary tract infection  1  0/31 (0.00%)  0 2/32 (6.25%)  3
Investigations     
Blood bilirubin increased  1  0/31 (0.00%)  0 2/32 (6.25%)  2
Haemoglobin decreased  1  2/31 (6.45%)  2 0/32 (0.00%)  0
Walking distance test abnormal  1  0/31 (0.00%)  0 2/32 (6.25%)  2
Metabolism and nutrition disorders     
Fluid retention  1  2/31 (6.45%)  3 0/32 (0.00%)  0
Hypokalaemia  1  2/31 (6.45%)  2 0/32 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hepatic neoplasm  1  2/31 (6.45%)  2 0/32 (0.00%)  0
Nervous system disorders     
Dizziness  1  2/31 (6.45%)  2 0/32 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/31 (3.23%)  1 2/32 (6.25%)  2
Dyspnoea  1  3/31 (9.68%)  4 4/32 (12.50%)  5
Pleural effusion  1  0/31 (0.00%)  0 2/32 (6.25%)  3
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure Desk
Organization: Actelion Pharmaceuticals Ltd
Phone: +41 61 565 6565
EMail: clinical-trials-disclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02070991    
Other Study ID Numbers: AC-055G201
First Submitted: February 21, 2014
First Posted: February 25, 2014
Results First Submitted: January 30, 2019
Results First Posted: May 15, 2019
Last Update Posted: May 15, 2019