Trial Outcomes & Findings for Study Effect of VIA-2291 on Vascular Inflammation (NCT NCT00358826)
NCT ID: NCT00358826
Last Updated: 2012-07-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
191 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2012-07-23
Participant Flow
Patients had an Acute Coronary Syndrome (ACS) within 3 weeks prior to randomization
Subset of patients agreed to participate in a Multi-Detector Computed Tomography (MDCT) substudy for an additional 12 weeks of treatment for a total of 24 weeks
Participant milestones
| Measure |
VIA-2291 25 mg
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
|
VIA-2291 50 mg
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
|
VIA-2291 100 mg
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
|
Placebo
Matching Placebo, 12 weeks
|
VIA-2291 25 mg MDCT Substudy
VIA-2291, 25 mg, oral dosing, daily, 24 weeks
|
VIA-2291 50 mg MDCT Substudy
VIA-2291, 50 mg, oral dosing, daily, 24 weeks
|
VIA-2291 100 mg MDCT Substudy
VIA-2291, 100 mg, oral dosing, daily, 24 weeks
|
Placebo MDCT Substudy
Matching Placebo, 24 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Core Study
STARTED
|
49
|
46
|
44
|
52
|
0
|
0
|
0
|
0
|
|
Core Study
COMPLETED
|
46
|
41
|
42
|
50
|
0
|
0
|
0
|
0
|
|
Core Study
NOT COMPLETED
|
3
|
5
|
2
|
2
|
0
|
0
|
0
|
0
|
|
MDCT Substudy
STARTED
|
0
|
0
|
0
|
0
|
25
|
22
|
19
|
27
|
|
MDCT Substudy
COMPLETED
|
0
|
0
|
0
|
0
|
24
|
20
|
19
|
27
|
|
MDCT Substudy
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
VIA-2291 25 mg
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
|
VIA-2291 50 mg
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
|
VIA-2291 100 mg
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
|
Placebo
Matching Placebo, 12 weeks
|
VIA-2291 25 mg MDCT Substudy
VIA-2291, 25 mg, oral dosing, daily, 24 weeks
|
VIA-2291 50 mg MDCT Substudy
VIA-2291, 50 mg, oral dosing, daily, 24 weeks
|
VIA-2291 100 mg MDCT Substudy
VIA-2291, 100 mg, oral dosing, daily, 24 weeks
|
Placebo MDCT Substudy
Matching Placebo, 24 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Core Study
Adverse Event
|
1
|
3
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Core Study
Withdrawal by Subject
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Core Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Core Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
MDCT Substudy
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
MDCT Substudy
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
MDCT Substudy
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study Effect of VIA-2291 on Vascular Inflammation
Baseline characteristics by cohort
| Measure |
VIA-2291 25 mg
n=49 Participants
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
|
VIA-2291 50 mg
n=46 Participants
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
|
VIA-2291 100 mg
n=44 Participants
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
|
Placebo
n=52 Participants
Matching Placebo, oral dosing, 12 weeks
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
149 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Age Continuous
|
56.4 years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 10.01 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 9.44 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 9.78 • n=4 Participants
|
57.0 years
STANDARD_DEVIATION 9.63 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
31 participants
n=5 Participants
|
34 participants
n=4 Participants
|
132 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
18 participants
n=4 Participants
|
59 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Core Study Evaluable Population
Outcome measures
| Measure |
VIA-2291 25 mg
n=43 Participants
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
|
VIA-2291 50 mg
n=36 Participants
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
|
VIA-2291 100 mg
n=38 Participants
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
|
Placebo
n=45 Participants
Matching Placebo, oral dosing, 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood
|
-88126 pg/mL
95% Confidence Interval 29.95 • Interval -100056.0 to -76196.0
|
-95703 pg/mL
95% Confidence Interval 31.01 • Interval -108810.0 to -82597.0
|
-122668 pg/mL
95% Confidence Interval 7.01 • Interval -135359.0 to -109976.0
|
-20843 pg/mL
95% Confidence Interval 174.12 • Interval -32509.0 to -9179.0
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Core Study Evaluable Population
Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate
Outcome measures
| Measure |
VIA-2291 25 mg
n=42 Participants
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
|
VIA-2291 50 mg
n=38 Participants
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
|
VIA-2291 100 mg
n=35 Participants
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
|
Placebo
n=44 Participants
Matching Placebo, oral dosing, 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Leukotriene E4 (LTE4)
|
-26.8 pg/mg Cr
Interval -39.3 to -14.4
|
-38.6 pg/mg Cr
Interval -51.7 to -25.5
|
-56.5 pg/mg Cr
Interval -70.2 to -42.9
|
8.4 pg/mg Cr
Interval -3.8 to 20.6
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Evaluable Population
Outcome measures
| Measure |
VIA-2291 25 mg
n=44 Participants
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
|
VIA-2291 50 mg
n=38 Participants
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
|
VIA-2291 100 mg
n=38 Participants
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
|
Placebo
n=48 Participants
Matching Placebo, oral dosing, 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study
|
-0.2 mg/L
Interval -1.1 to 0.4
|
-0.1 mg/L
Interval -1.9 to 0.1
|
-0.3 mg/L
Interval -0.8 to 0.1
|
-0.2 mg/L
Interval -0.9 to 0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 24 weeksPopulation: Evaluable Population of the MDCT substudy
Outcome measures
| Measure |
VIA-2291 25 mg
n=23 Participants
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
|
VIA-2291 50 mg
n=20 Participants
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
|
VIA-2291 100 mg
n=18 Participants
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
|
Placebo
n=27 Participants
Matching Placebo, oral dosing, 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy
|
-0.4 mg/L
Interval -1.2 to 0.3
|
-0.2 mg/L
Interval -3.7 to 0.2
|
-0.4 mg/L
Interval -3.9 to -0.2
|
0.0 mg/L
Interval -0.5 to 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 24 weeksPopulation: Evaluable Population
Outcome measures
| Measure |
VIA-2291 25 mg
n=7 Participants
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
|
VIA-2291 50 mg
n=8 Participants
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
|
VIA-2291 100 mg
n=7 Participants
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
|
Placebo
n=12 Participants
Matching Placebo, oral dosing, 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Noncalcified Plaque Volume
|
-1.55 mm^3
Interval -5.62 to 2.51
|
-5.6 mm^3
Interval -9.49 to -1.71
|
0.15 mm^3
Interval -3.84 to 4.14
|
2.83 mm^3
Interval -0.18 to 5.84
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 24 weeksPopulation: Evaluable Population
Plaque density is expressed in Hounsfield Units (HU)
Outcome measures
| Measure |
VIA-2291 25 mg
n=7 Participants
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
|
VIA-2291 50 mg
n=8 Participants
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
|
VIA-2291 100 mg
n=7 Participants
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
|
Placebo
n=12 Participants
Matching Placebo, oral dosing, 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Mean Plaque Density
|
19.11 HU
Interval -1.51 to 39.74
|
7.39 HU
Interval -11.96 to 26.74
|
12.22 HU
Interval -8.38 to 32.82
|
12.42 HU
Interval -3.32 to 28.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 24 weeksPopulation: Evaluable Population
Outcome measures
| Measure |
VIA-2291 25 mg
n=7 Participants
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
|
VIA-2291 50 mg
n=8 Participants
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
|
VIA-2291 100 mg
n=7 Participants
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
|
Placebo
n=12 Participants
Matching Placebo, oral dosing, 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Percent Stenosis
|
-0.11 Percentage
Interval -8.24 to 8.03
|
11.45 Percentage
Interval 3.73 to 19.17
|
2.36 Percentage
Interval -5.7 to 10.42
|
1.19 Percentage
Interval -4.95 to 7.32
|
Adverse Events
VIA-2291 25 mg
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
VIA-2291 50 mg
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
VIA-2291 100 mg
Serious events: 7 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VIA-2291 25 mg
n=49 participants at risk
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
|
VIA-2291 50 mg
n=46 participants at risk
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
|
VIA-2291 100 mg
n=44 participants at risk
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
|
Placebo
n=52 participants at risk
Matching Placebo, oral dosing, 12 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Angina Unstable
|
2.0%
1/49 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
4.5%
2/44 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.2%
1/46 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.0%
1/49 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
—
0/0 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/44 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
1.9%
1/52 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.2%
1/46 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/44 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/44 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
1.9%
1/52 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
General disorders
Non-cardiac Chest Pain
|
2.0%
1/49 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
General disorders
Chest Discomfort
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
General disorders
Chest Pain
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Infections and infestations
Bronchitis
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
General disorders
Pneumonia
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/44 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
1.9%
1/52 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Nervous system disorders
Presyncope
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.2%
1/46 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/44 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Nervous system disorders
Syncope
|
2.0%
1/49 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/44 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Vascular disorders
Accelerated Hypertension
|
2.0%
1/49 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/44 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/44 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
1.9%
1/52 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's Lymphoma
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/44 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
1.9%
1/52 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
Other adverse events
| Measure |
VIA-2291 25 mg
n=49 participants at risk
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
|
VIA-2291 50 mg
n=46 participants at risk
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
|
VIA-2291 100 mg
n=44 participants at risk
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
|
Placebo
n=52 participants at risk
Matching Placebo, oral dosing, 12 weeks
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
8.2%
4/49 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
13.0%
6/46 • Number of events 6 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
15.9%
7/44 • Number of events 7 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
9.6%
5/52 • Number of events 5 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
General disorders
Non-cardiac Chest Pain
|
10.2%
5/49 • Number of events 5 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
6.5%
3/46 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
9.1%
4/44 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
7.7%
4/52 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
General disorders
Chest pain
|
6.1%
3/49 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
4.3%
2/46 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
4.5%
2/44 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
14.3%
7/49 • Number of events 7 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
8.7%
4/46 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
11.4%
5/44 • Number of events 5 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
7.7%
4/52 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.1%
3/49 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
10.9%
5/46 • Number of events 5 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/44 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
5.8%
3/52 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
4/49 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
6.8%
3/44 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
1.9%
1/52 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.1%
2/49 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
6.5%
3/46 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
4/49 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
4.5%
2/44 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
3.8%
2/52 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Nervous system disorders
Headache
|
10.2%
5/49 • Number of events 5 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
10.9%
5/46 • Number of events 5 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
11.4%
5/44 • Number of events 5 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
11.5%
6/52 • Number of events 6 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Nervous system disorders
Dizziness
|
2.0%
1/49 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
6.5%
3/46 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
15.9%
7/44 • Number of events 7 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
9.6%
5/52 • Number of events 5 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/49 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
6.5%
3/46 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
15.9%
7/44 • Number of events 7 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
3.8%
2/52 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
6.1%
3/49 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
4.3%
2/46 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
9.1%
4/44 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/49 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
10.9%
5/46 • Number of events 5 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
3.8%
2/52 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
6.5%
3/46 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/44 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Gastrointestinal disorders
Nausea
|
6.1%
3/49 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.2%
1/46 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
9.1%
4/44 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
1.9%
1/52 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Gastrointestinal disorders
Dspepsia
|
6.1%
3/49 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.2%
1/46 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
6.8%
3/44 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
1.9%
1/52 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
8.2%
4/49 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
8.7%
4/46 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
9.1%
4/44 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
5.8%
3/52 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.1%
2/49 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.2%
1/46 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
9.1%
4/44 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/52 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Cardiac disorders
Angina Pectoris
|
6.1%
3/49 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
17.4%
8/46 • Number of events 8 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
15.9%
7/44 • Number of events 7 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
9.6%
5/52 • Number of events 5 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/49 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
10.9%
5/46 • Number of events 5 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/44 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
7.7%
4/52 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.1%
2/49 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
4.3%
2/46 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
7.7%
4/52 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Injury, poisoning and procedural complications
Contusion
|
10.2%
5/49 • Number of events 5 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
4.3%
2/46 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
9.1%
4/44 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
13.5%
7/52 • Number of events 7 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Investigations
Alanine Aminotransferase Increased
|
10.2%
5/49 • Number of events 5 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.2%
1/46 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
5.8%
3/52 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/44 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
7.7%
4/52 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Vascular disorders
Hypertension
|
2.0%
1/49 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
8.7%
4/46 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
1.9%
1/52 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Vascular disorders
Hypotension
|
4.1%
2/49 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.2%
1/46 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
4.5%
2/44 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
5.8%
3/52 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Psychiatric disorders
Insomnia
|
4.1%
2/49 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
0.00%
0/46 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
9.1%
4/44 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
3.8%
2/52 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Psychiatric disorders
Depression
|
0.00%
0/49 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.2%
1/46 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
9.1%
4/44 • Number of events 4 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
1.9%
1/52 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
3/49 • Number of events 3 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
4.3%
2/46 • Number of events 2 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
2.3%
1/44 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
1.9%
1/52 • Number of events 1 • 12 weeks for Core Study and 24 weeks for MDCT substudy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER