Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis

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: NCT01006265
Recruitment Status : Completed
First Posted : November 1, 2009
Results First Posted : June 11, 2021
Last Update Posted : June 11, 2021
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 Multiple Sclerosis
Interventions Drug: ACT-128800 Dose 1
Drug: Placebo
Drug: ACT-128800 Dose 2
Drug: ACT-128800 Dose 3
Enrollment 464
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ponesimod 40 mg Ponesimod 20 mg Ponesimod 10 mg Placebo
Hide Arm/Group Description Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24. Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24. Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24. Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
Period Title: Overall Study
Started 119 116 108 121
Treated 119 114 108 121
Completed 113 107 99 116
Not Completed 6 9 9 5
Reason Not Completed
Lost to Follow-up             1             0             1             0
Withdrawal by Subject             4             7             5             5
Administrative reason             1             2             3             0
Arm/Group Title Ponesimod 40 mg Ponesimod 20 mg Ponesimod 10 mg Placebo Total
Hide Arm/Group Description Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24. Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24. Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24. Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule. Total of all reporting groups
Overall Number of Baseline Participants 119 116 108 121 464
Hide Baseline Analysis Population Description
All-randomized analysis set included all randomized participants, whether or not they received study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age ( years ) Number Analyzed 119 participants 116 participants 108 participants 121 participants 464 participants
36.5  (8.52) 35.3  (8.52) 36.9  (9.24) 36.6  (8.58) 36.3  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Gender Number Analyzed 119 participants 116 participants 108 participants 121 participants 464 participants
Female
79
  66.4%
78
  67.2%
71
  65.7%
85
  70.2%
313
  67.5%
Male
40
  33.6%
38
  32.8%
37
  34.3%
36
  29.8%
151
  32.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 116 participants 108 participants 121 participants 464 participants
Hispanic or Latino
2
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.4%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
117
  98.3%
116
 100.0%
108
 100.0%
121
 100.0%
462
  99.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 116 participants 108 participants 121 participants 464 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
1
   0.2%
Asian
1
   0.8%
0
   0.0%
1
   0.9%
0
   0.0%
2
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   1.7%
2
   1.7%
2
   1.9%
6
   5.0%
12
   2.6%
White
114
  95.8%
114
  98.3%
105
  97.2%
114
  94.2%
447
  96.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 116 participants 108 participants 121 participants 464 participants
Australia
0
   0.0%
1
   0.9%
0
   0.0%
0
   0.0%
1
   0.2%
Austria
2
   1.7%
2
   1.7%
2
   1.9%
3
   2.5%
9
   1.9%
Belgium
2
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.4%
Bulgaria
5
   4.2%
4
   3.4%
5
   4.6%
5
   4.1%
19
   4.1%
Canada
3
   2.5%
3
   2.6%
4
   3.7%
3
   2.5%
13
   2.8%
Finland
6
   5.0%
4
   3.4%
4
   3.7%
6
   5.0%
20
   4.3%
Czech Republic
14
  11.8%
14
  12.1%
12
  11.1%
12
   9.9%
52
  11.2%
France
1
   0.8%
1
   0.9%
1
   0.9%
1
   0.8%
4
   0.9%
Germany
1
   0.8%
2
   1.7%
1
   0.9%
2
   1.7%
6
   1.3%
Hungary
7
   5.9%
7
   6.0%
2
   1.9%
3
   2.5%
19
   4.1%
Israel
3
   2.5%
2
   1.7%
1
   0.9%
3
   2.5%
9
   1.9%
Italy
8
   6.7%
7
   6.0%
6
   5.6%
7
   5.8%
28
   6.0%
Netherlands
1
   0.8%
1
   0.9%
2
   1.9%
2
   1.7%
6
   1.3%
Poland
7
   5.9%
8
   6.9%
10
   9.3%
12
   9.9%
37
   8.0%
Romania
1
   0.8%
2
   1.7%
3
   2.8%
3
   2.5%
9
   1.9%
Russia
9
   7.6%
9
   7.8%
8
   7.4%
7
   5.8%
33
   7.1%
Spain
4
   3.4%
2
   1.7%
3
   2.8%
4
   3.3%
13
   2.8%
Serbia
10
   8.4%
10
   8.6%
11
  10.2%
11
   9.1%
42
   9.1%
Sweden
5
   4.2%
6
   5.2%
4
   3.7%
6
   5.0%
21
   4.5%
Switzerland
0
   0.0%
2
   1.7%
2
   1.9%
1
   0.8%
5
   1.1%
United Kingdom
5
   4.2%
5
   4.3%
4
   3.7%
4
   3.3%
18
   3.9%
Ukraine
5
   4.2%
6
   5.2%
5
   4.6%
7
   5.8%
23
   5.0%
United States
20
  16.8%
18
  15.5%
18
  16.7%
19
  15.7%
75
  16.2%
1.Primary Outcome
Title Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24
Hide Description Cumulative Number of new T1 gadolinium-enhancing (Gd+) lesions per year on magnetic resonance imaging (MRI) scan from Week 12 to Week 24 were reported. Negative binomial (NB) regression analysis on Per protocol analysis set and imputation was applied for the missing data. Here, MS signifies multiple sclerosis.
Time Frame From Week 12 to 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis set included participants of mITT set (randomized participants who received at least one dose of study drug, and had at least one valid post-baseline MRI) who met the criteria for evaluable participants for the analysis of MRI data (participants with Relapsing-remitting multiple sclerosis (RRMS) received study drug until 168 days, two post-baseline MRIs b/w Week 12-24, no forbidden treatment for MS).
Arm/Group Title Ponesimod 40 mg Ponesimod 20 mg Ponesimod 10 mg Placebo
Hide Arm/Group Description:
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
Overall Number of Participants Analyzed 93 98 88 110
Mean (Standard Deviation)
Unit of Measure: Lesions
1.4  (3.24) 1.1  (1.96) 3.5  (7.27) 6.2  (13.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ponesimod 40 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Negative binomial regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment effect (rate ratio)
Estimated Value 0.226
Confidence Interval (2-Sided) 95%
0.133 to 0.384
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ponesimod 20 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Negative binomial regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment effect (rate ratio)
Estimated Value 0.170
Confidence Interval (2-Sided) 95%
0.100 to 0.289
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ponesimod 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0318
Comments [Not Specified]
Method Negative binomial regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment effect (rate ratio)
Estimated Value 0.566
Confidence Interval (2-Sided) 95%
0.337 to 0.952
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Annualized Confirmed Relapse Rate
Hide Description Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple Sclerosis (MS), not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS)
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all randomized participants who received at least one dose of study drug.
Arm/Group Title Ponesimod 40 mg Ponesimod 20 mg Ponesimod 10 mg Placebo
Hide Arm/Group Description:
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
Overall Number of Participants Analyzed 119 114 108 121
Mean (Standard Deviation)
Unit of Measure: Relapse per year
0.224  (0.7834) 0.396  (1.0169) 0.297  (0.7987) 0.601  (1.6626)
3.Secondary Outcome
Title Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24
Hide Description Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of MS, not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS). Kaplan-Meier estimate used for Outcome Measure analysis.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all randomized participants who received at least one dose of study drug. Here 'N' (number of participants analyzed) included all participants who were evaluated for this outcome measure.
Arm/Group Title Ponesimod 40 mg Ponesimod 20 mg Ponesimod 10 mg Placebo
Hide Arm/Group Description:
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
Overall Number of Participants Analyzed 66 71 60 65
Measure Type: Count of Participants
Unit of Measure: Participants
10
  15.2%
17
  23.9%
14
  23.3%
25
  38.5%
Time Frame Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
Adverse Event Reporting Description All Treated Analysis set included all randomized participants who received at least one dose of study drug.
 
Arm/Group Title Ponesimod 40 mg Ponesimod 20 mg Ponesimod 10 mg Placebo
Hide Arm/Group Description Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24. Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24. Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24. Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
All-Cause Mortality
Ponesimod 40 mg Ponesimod 20 mg Ponesimod 10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/119 (0.00%)   0/114 (0.00%)   0/108 (0.00%)   0/121 (0.00%) 
Hide Serious Adverse Events
Ponesimod 40 mg Ponesimod 20 mg Ponesimod 10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/119 (2.52%)   7/114 (6.14%)   7/108 (6.48%)   5/121 (4.13%) 
Cardiac disorders         
Atrioventricular Block Second Degree * 1  0/119 (0.00%)  1/114 (0.88%)  2/108 (1.85%)  0/121 (0.00%) 
Coronary Artery Disease * 1  0/119 (0.00%)  0/114 (0.00%)  1/108 (0.93%)  0/121 (0.00%) 
Ear and labyrinth disorders         
Vertigo * 1  0/119 (0.00%)  0/114 (0.00%)  1/108 (0.93%)  0/121 (0.00%) 
Eye disorders         
Macular Oedema * 1  0/119 (0.00%)  2/114 (1.75%)  0/108 (0.00%)  0/121 (0.00%) 
Papilloedema * 1  0/119 (0.00%)  1/114 (0.88%)  0/108 (0.00%)  0/121 (0.00%) 
Gastrointestinal disorders         
Abdominal Pain Upper * 1  0/119 (0.00%)  1/114 (0.88%)  0/108 (0.00%)  0/121 (0.00%) 
General disorders         
Pyrexia * 1  0/119 (0.00%)  0/114 (0.00%)  1/108 (0.93%)  0/121 (0.00%) 
Immune system disorders         
Anaphylactoid Reaction * 1  0/119 (0.00%)  0/114 (0.00%)  0/108 (0.00%)  1/121 (0.83%) 
Infections and infestations         
Appendicitis * 1  1/119 (0.84%)  1/114 (0.88%)  0/108 (0.00%)  0/121 (0.00%) 
Cellulitis * 1  1/119 (0.84%)  0/114 (0.00%)  0/108 (0.00%)  0/121 (0.00%) 
Measles * 1  0/119 (0.00%)  0/114 (0.00%)  0/108 (0.00%)  1/121 (0.83%) 
Urinary Tract Infection Bacterial * 1  0/119 (0.00%)  0/114 (0.00%)  0/108 (0.00%)  1/121 (0.83%) 
Investigations         
Alanine Aminotransferase Increased * 1  0/119 (0.00%)  0/114 (0.00%)  1/108 (0.93%)  0/121 (0.00%) 
Aspartate Aminotransferase Increased * 1  0/119 (0.00%)  0/114 (0.00%)  1/108 (0.93%)  0/121 (0.00%) 
Electrocardiogram QT Prolonged * 1  0/119 (0.00%)  0/114 (0.00%)  1/108 (0.93%)  0/121 (0.00%) 
Nuclear Magnetic Resonance Imaging Abnormal * 1  0/119 (0.00%)  1/114 (0.88%)  0/108 (0.00%)  0/121 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast Cancer * 1  0/119 (0.00%)  0/114 (0.00%)  1/108 (0.93%)  0/121 (0.00%) 
Cervix Carcinoma * 1  0/119 (0.00%)  0/114 (0.00%)  0/108 (0.00%)  1/121 (0.83%) 
Nervous system disorders         
Somnolence * 1  0/119 (0.00%)  0/114 (0.00%)  1/108 (0.93%)  0/121 (0.00%) 
Reproductive system and breast disorders         
Postmenopausal Haemorrhage * 1  0/119 (0.00%)  0/114 (0.00%)  0/108 (0.00%)  1/121 (0.83%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea * 1  1/119 (0.84%)  0/114 (0.00%)  0/108 (0.00%)  0/121 (0.00%) 
Pleural Effusion * 1  1/119 (0.84%)  0/114 (0.00%)  0/108 (0.00%)  0/121 (0.00%) 
Surgical and medical procedures         
Appendicectomy * 1  0/119 (0.00%)  1/114 (0.88%)  0/108 (0.00%)  0/121 (0.00%) 
1
Term from vocabulary, MedDRA Version 14.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Ponesimod 40 mg Ponesimod 20 mg Ponesimod 10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   83/119 (69.75%)   73/114 (64.04%)   69/108 (63.89%)   77/121 (63.64%) 
Blood and lymphatic system disorders         
Lymphopenia * 1  1/119 (0.84%)  3/114 (2.63%)  1/108 (0.93%)  0/121 (0.00%) 
Cardiac disorders         
Bradycardia * 1  2/119 (1.68%)  5/114 (4.39%)  0/108 (0.00%)  0/121 (0.00%) 
Palpitations * 1  2/119 (1.68%)  1/114 (0.88%)  3/108 (2.78%)  3/121 (2.48%) 
Ear and labyrinth disorders         
Ear Pain * 1  0/119 (0.00%)  1/114 (0.88%)  1/108 (0.93%)  3/121 (2.48%) 
Eye disorders         
Eye Pain * 1  0/119 (0.00%)  0/114 (0.00%)  3/108 (2.78%)  2/121 (1.65%) 
Gastrointestinal disorders         
Abdominal Pain * 1  1/119 (0.84%)  0/114 (0.00%)  0/108 (0.00%)  3/121 (2.48%) 
Abdominal Pain Upper * 1  3/119 (2.52%)  1/114 (0.88%)  1/108 (0.93%)  1/121 (0.83%) 
Diarrhoea * 1  3/119 (2.52%)  3/114 (2.63%)  3/108 (2.78%)  8/121 (6.61%) 
Dry Mouth * 1  0/119 (0.00%)  3/114 (2.63%)  0/108 (0.00%)  1/121 (0.83%) 
Dyspepsia * 1  1/119 (0.84%)  3/114 (2.63%)  0/108 (0.00%)  2/121 (1.65%) 
Nausea * 1  4/119 (3.36%)  3/114 (2.63%)  2/108 (1.85%)  6/121 (4.96%) 
Vomiting * 1  2/119 (1.68%)  1/114 (0.88%)  3/108 (2.78%)  0/121 (0.00%) 
General disorders         
Asthenia * 1  3/119 (2.52%)  1/114 (0.88%)  1/108 (0.93%)  4/121 (3.31%) 
Chest Discomfort * 1  4/119 (3.36%)  5/114 (4.39%)  0/108 (0.00%)  3/121 (2.48%) 
Disease Progression * 1  11/119 (9.24%)  9/114 (7.89%)  10/108 (9.26%)  6/121 (4.96%) 
Fatigue * 1  6/119 (5.04%)  9/114 (7.89%)  7/108 (6.48%)  7/121 (5.79%) 
Oedema Peripheral * 1  13/119 (10.92%)  3/114 (2.63%)  2/108 (1.85%)  2/121 (1.65%) 
Pain * 1  0/119 (0.00%)  0/114 (0.00%)  0/108 (0.00%)  3/121 (2.48%) 
Infections and infestations         
Bronchitis * 1  5/119 (4.20%)  4/114 (3.51%)  4/108 (3.70%)  3/121 (2.48%) 
Gastroenteritis * 1  1/119 (0.84%)  3/114 (2.63%)  5/108 (4.63%)  4/121 (3.31%) 
Influenza * 1  5/119 (4.20%)  3/114 (2.63%)  3/108 (2.78%)  2/121 (1.65%) 
Nasopharyngitis * 1  13/119 (10.92%)  12/114 (10.53%)  16/108 (14.81%)  17/121 (14.05%) 
Oral Herpes * 1  2/119 (1.68%)  0/114 (0.00%)  2/108 (1.85%)  6/121 (4.96%) 
Rhinitis * 1  0/119 (0.00%)  4/114 (3.51%)  3/108 (2.78%)  1/121 (0.83%) 
Sinusitis * 1  6/119 (5.04%)  5/114 (4.39%)  4/108 (3.70%)  5/121 (4.13%) 
Upper Respiratory Tract Infection * 1  11/119 (9.24%)  9/114 (7.89%)  4/108 (3.70%)  11/121 (9.09%) 
Urinary Tract Infection * 1  3/119 (2.52%)  1/114 (0.88%)  2/108 (1.85%)  6/121 (4.96%) 
Injury, poisoning and procedural complications         
Contusion * 1  1/119 (0.84%)  1/114 (0.88%)  3/108 (2.78%)  0/121 (0.00%) 
Muscle Strain * 1  0/119 (0.00%)  1/114 (0.88%)  3/108 (2.78%)  0/121 (0.00%) 
Investigations         
Alanine Aminotransferase Increased * 1  7/119 (5.88%)  7/114 (6.14%)  4/108 (3.70%)  1/121 (0.83%) 
Blood Cholesterol Increased * 1  2/119 (1.68%)  3/114 (2.63%)  3/108 (2.78%)  1/121 (0.83%) 
Forced Expiratory Volume Decreased * 1  3/119 (2.52%)  2/114 (1.75%)  2/108 (1.85%)  0/121 (0.00%) 
Hepatic Enzyme Increased * 1  1/119 (0.84%)  0/114 (0.00%)  3/108 (2.78%)  0/121 (0.00%) 
Pulmonary Function Test Decreased * 1  5/119 (4.20%)  0/114 (0.00%)  2/108 (1.85%)  0/121 (0.00%) 
Metabolism and nutrition disorders         
Hypercholesterolaemia * 1  3/119 (2.52%)  3/114 (2.63%)  2/108 (1.85%)  2/121 (1.65%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  1/119 (0.84%)  1/114 (0.88%)  2/108 (1.85%)  7/121 (5.79%) 
Back Pain * 1  6/119 (5.04%)  5/114 (4.39%)  2/108 (1.85%)  6/121 (4.96%) 
Joint Swelling * 1  1/119 (0.84%)  4/114 (3.51%)  0/108 (0.00%)  0/121 (0.00%) 
Muscle Spasms * 1  3/119 (2.52%)  0/114 (0.00%)  1/108 (0.93%)  5/121 (4.13%) 
Musculoskeletal Chest Pain * 1  3/119 (2.52%)  1/114 (0.88%)  1/108 (0.93%)  1/121 (0.83%) 
Musculoskeletal Pain * 1  1/119 (0.84%)  0/114 (0.00%)  3/108 (2.78%)  3/121 (2.48%) 
Myalgia * 1  1/119 (0.84%)  2/114 (1.75%)  1/108 (0.93%)  5/121 (4.13%) 
Pain in Extremity * 1  2/119 (1.68%)  3/114 (2.63%)  0/108 (0.00%)  1/121 (0.83%) 
Nervous system disorders         
Dizziness * 1  11/119 (9.24%)  7/114 (6.14%)  8/108 (7.41%)  3/121 (2.48%) 
Headache * 1  15/119 (12.61%)  16/114 (14.04%)  15/108 (13.89%)  18/121 (14.88%) 
Hypoaesthesia * 1  3/119 (2.52%)  2/114 (1.75%)  2/108 (1.85%)  2/121 (1.65%) 
Migraine * 1  5/119 (4.20%)  3/114 (2.63%)  1/108 (0.93%)  0/121 (0.00%) 
Paraesthesia * 1  1/119 (0.84%)  2/114 (1.75%)  3/108 (2.78%)  1/121 (0.83%) 
Psychiatric disorders         
Affect Lability * 1  0/119 (0.00%)  0/114 (0.00%)  0/108 (0.00%)  3/121 (2.48%) 
Anxiety * 1  4/119 (3.36%)  3/114 (2.63%)  5/108 (4.63%)  0/121 (0.00%) 
Depression * 1  4/119 (3.36%)  3/114 (2.63%)  1/108 (0.93%)  1/121 (0.83%) 
Insomnia * 1  2/119 (1.68%)  4/114 (3.51%)  4/108 (3.70%)  1/121 (0.83%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  8/119 (6.72%)  3/114 (2.63%)  1/108 (0.93%)  2/121 (1.65%) 
Dyspnoea * 1  16/119 (13.45%)  7/114 (6.14%)  5/108 (4.63%)  4/121 (3.31%) 
Oropharyngeal Pain * 1  5/119 (4.20%)  2/114 (1.75%)  4/108 (3.70%)  4/121 (3.31%) 
1
Term from vocabulary, MedDRA Version 14.0
*
Indicates events were collected by non-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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Leader
Organization: Actelion Pharmaceuticals Ltd.
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01006265    
Other Study ID Numbers: AC-058B201
First Submitted: October 30, 2009
First Posted: November 1, 2009
Results First Submitted: April 1, 2021
Results First Posted: June 11, 2021
Last Update Posted: June 11, 2021