Trial Outcomes & Findings for A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction (NCT NCT03098979)
NCT ID: NCT03098979
Last Updated: 2019-07-23
Results Overview
The 6MWD test is designed to evaluate a subject's exercise capacity while performing an everyday activity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
305 participants
Primary outcome timeframe
Baseline, and up to 20 weeks of treatment
Results posted on
2019-07-23
Participant Flow
The study was conducted at 76 study centers in 12 countries, between 10 May 2017 (first patient first visit) and 20 June 2018 (last patient last visit)
A total of 339 subjects entered the screening period, of whom 34 withdrew before randomization. The remaining 305 subjects were randomized and received at least one dose of study drug
Participant milestones
| Measure |
Placebo
Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 5 mg
Subjects received 5 milligrams (mg) of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 10 mg
Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 20 mg
Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 30 mg
Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 40 mg
Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
76
|
27
|
50
|
51
|
50
|
51
|
|
Overall Study
COMPLETED
|
70
|
25
|
46
|
46
|
41
|
47
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
4
|
5
|
9
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 5 mg
Subjects received 5 milligrams (mg) of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 10 mg
Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 20 mg
Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 30 mg
Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 40 mg
Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
4
|
6
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
1
|
2
|
1
|
|
Overall Study
Death
|
1
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Non-compliance
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Included subjects with valid baseline value for this characteristic
Baseline characteristics by cohort
| Measure |
Placebo
n=76 Participants
Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 5 mg
n=27 Participants
Subjects received 5 milligrams (mg) of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 10 mg
n=50 Participants
Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 20 mg
n=51 Participants
Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 30 mg
n=50 Participants
Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 40 mg
n=51 Participants
Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
73.1 Years
STANDARD_DEVIATION 8.0 • n=76 Participants
|
74.3 Years
STANDARD_DEVIATION 9.3 • n=27 Participants
|
73.5 Years
STANDARD_DEVIATION 9.9 • n=50 Participants
|
71.4 Years
STANDARD_DEVIATION 6.8 • n=51 Participants
|
76 Years
STANDARD_DEVIATION 9.4 • n=50 Participants
|
73.7 Years
STANDARD_DEVIATION 8.3 • n=51 Participants
|
73.6 Years
STANDARD_DEVIATION 8.6 • n=305 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=76 Participants
|
16 Participants
n=27 Participants
|
26 Participants
n=50 Participants
|
21 Participants
n=51 Participants
|
32 Participants
n=50 Participants
|
29 Participants
n=51 Participants
|
160 Participants
n=305 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=76 Participants
|
11 Participants
n=27 Participants
|
24 Participants
n=50 Participants
|
30 Participants
n=51 Participants
|
18 Participants
n=50 Participants
|
22 Participants
n=51 Participants
|
145 Participants
n=305 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=76 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
2 Participants
n=305 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=76 Participants
|
27 Participants
n=27 Participants
|
49 Participants
n=50 Participants
|
51 Participants
n=51 Participants
|
50 Participants
n=50 Participants
|
50 Participants
n=51 Participants
|
300 Participants
n=305 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=76 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=51 Participants
|
3 Participants
n=305 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=76 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=76 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=50 Participants
|
5 Participants
n=51 Participants
|
5 Participants
n=50 Participants
|
5 Participants
n=51 Participants
|
33 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=76 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=76 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=51 Participants
|
5 Participants
n=305 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=76 Participants
|
24 Participants
n=27 Participants
|
44 Participants
n=50 Participants
|
45 Participants
n=51 Participants
|
45 Participants
n=50 Participants
|
45 Participants
n=51 Participants
|
267 Participants
n=305 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=76 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=305 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=76 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=305 Participants
|
|
LVEF
|
57.09 percentage of blood ejected
STANDARD_DEVIATION 8.68 • n=45 Participants • Included subjects with valid baseline value for this characteristic
|
56.54 percentage of blood ejected
STANDARD_DEVIATION 9.62 • n=20 Participants • Included subjects with valid baseline value for this characteristic
|
53.78 percentage of blood ejected
STANDARD_DEVIATION 11.6 • n=32 Participants • Included subjects with valid baseline value for this characteristic
|
57.3 percentage of blood ejected
STANDARD_DEVIATION 10.4 • n=32 Participants • Included subjects with valid baseline value for this characteristic
|
59.43 percentage of blood ejected
STANDARD_DEVIATION 8.72 • n=32 Participants • Included subjects with valid baseline value for this characteristic
|
52.3 percentage of blood ejected
STANDARD_DEVIATION 12.76 • n=33 Participants • Included subjects with valid baseline value for this characteristic
|
56.09 percentage of blood ejected
STANDARD_DEVIATION 10.5 • n=194 Participants • Included subjects with valid baseline value for this characteristic
|
|
NT-proBNP
|
882.0 pg/ml
n=63 Participants • Included subjects with valid baseline value for this characteristic
|
1013.0 pg/ml
n=23 Participants • Included subjects with valid baseline value for this characteristic
|
1000.0 pg/ml
n=44 Participants • Included subjects with valid baseline value for this characteristic
|
834.5 pg/ml
n=42 Participants • Included subjects with valid baseline value for this characteristic
|
626.0 pg/ml
n=39 Participants • Included subjects with valid baseline value for this characteristic
|
886.5 pg/ml
n=44 Participants • Included subjects with valid baseline value for this characteristic
|
869.0 pg/ml
n=255 Participants • Included subjects with valid baseline value for this characteristic
|
|
NYHA class
II
|
61 Participants
n=76 Participants
|
23 Participants
n=27 Participants
|
37 Participants
n=50 Participants
|
41 Participants
n=51 Participants
|
31 Participants
n=50 Participants
|
39 Participants
n=51 Participants
|
232 Participants
n=305 Participants
|
|
NYHA class
III/IV
|
15 Participants
n=76 Participants
|
4 Participants
n=27 Participants
|
13 Participants
n=50 Participants
|
10 Participants
n=51 Participants
|
19 Participants
n=50 Participants
|
12 Participants
n=51 Participants
|
73 Participants
n=305 Participants
|
|
Medical history: diabetes
|
36 Participants
n=76 Participants
|
7 Participants
n=27 Participants
|
23 Participants
n=50 Participants
|
20 Participants
n=51 Participants
|
22 Participants
n=50 Participants
|
21 Participants
n=51 Participants
|
129 Participants
n=305 Participants
|
|
Medical history: Atrial fibrillation
|
28 Participants
n=76 Participants
|
10 Participants
n=27 Participants
|
18 Participants
n=50 Participants
|
19 Participants
n=51 Participants
|
20 Participants
n=50 Participants
|
21 Participants
n=51 Participants
|
116 Participants
n=305 Participants
|
|
Medical history: hypertension
|
66 Participants
n=76 Participants
|
25 Participants
n=27 Participants
|
45 Participants
n=50 Participants
|
45 Participants
n=51 Participants
|
46 Participants
n=50 Participants
|
42 Participants
n=51 Participants
|
269 Participants
n=305 Participants
|
|
eGFR
|
62.0 mL/min/1.73 square meter
STANDARD_DEVIATION 17.9 • n=76 Participants
|
52.6 mL/min/1.73 square meter
STANDARD_DEVIATION 17.1 • n=27 Participants
|
61.0 mL/min/1.73 square meter
STANDARD_DEVIATION 24.2 • n=50 Participants
|
57.1 mL/min/1.73 square meter
STANDARD_DEVIATION 17.3 • n=51 Participants
|
57.5 mL/min/1.73 square meter
STANDARD_DEVIATION 18.2 • n=50 Participants
|
60.0 mL/min/1.73 square meter
STANDARD_DEVIATION 17.5 • n=51 Participants
|
59.1 mL/min/1.73 square meter
STANDARD_DEVIATION 18.9 • n=305 Participants
|
|
6MWD
|
322.8 meter
STANDARD_DEVIATION 97.1 • n=76 Participants
|
311.6 meter
STANDARD_DEVIATION 108.2 • n=27 Participants
|
295.8 meter
STANDARD_DEVIATION 110.4 • n=50 Participants
|
324.5 meter
STANDARD_DEVIATION 105 • n=51 Participants
|
321.1 meter
STANDARD_DEVIATION 93.4 • n=50 Participants
|
347.2 meter
STANDARD_DEVIATION 94.5 • n=51 Participants
|
321.5 meter
STANDARD_DEVIATION 101 • n=305 Participants
|
PRIMARY outcome
Timeframe: Baseline, and up to 20 weeks of treatmentPopulation: Per-protocol set (PPS): Included all full analysis set (FAS) population subjects without validity findings for this outcome measure, and it also included subjects who were censored due to cardiovascular (CV) death or hospitalization for heart failure (HF) that prevented assessment of efficacy at 20 weeks.
The 6MWD test is designed to evaluate a subject's exercise capacity while performing an everyday activity.
Outcome measures
| Measure |
Placebo
n=65 Participants
Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 5 mg
n=22 Participants
Subjects received 5 milligrams (mg) of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 10 mg
n=44 Participants
Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 20 mg
n=41 Participants
Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 30 mg
n=34 Participants
Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 40 mg
n=37 Participants
Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment
Value at baseline
|
329 meter
Standard Deviation 95
|
306 meter
Standard Deviation 117
|
300 meter
Standard Deviation 109
|
328 meter
Standard Deviation 105
|
321 meter
Standard Deviation 101
|
363 meter
Standard Deviation 83
|
|
Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment
Change from baseline to Week 20
|
1.89 meter
Standard Deviation 49.5
|
24.8 meter
Standard Deviation 72.4
|
27.2 meter
Standard Deviation 90.0
|
14.6 meter
Standard Deviation 54.1
|
16.3 meter
Standard Deviation 55.4
|
10.7 meter
Standard Deviation 60.2
|
SECONDARY outcome
Timeframe: Baseline, and up to 20 weeks of treatmentPopulation: Per-protocol set (PPS): Included all full analysis set (FAS) population subjects without validity findings for this outcome measure
AVIVO™ Mobile Patient Management System, a wearable wireless device worn by the subject, was used to monitor subjects' cardiovascular status. The patient's everyday physical activity e.g. duration, intensity, was also tracked by the AVIVO device. For Activity Intensity, the Unit of Measure is "percentage of maximum activity", and length of intervals is "daily".
Outcome measures
| Measure |
Placebo
n=56 Participants
Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 5 mg
n=20 Participants
Subjects received 5 milligrams (mg) of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 10 mg
n=39 Participants
Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 20 mg
n=35 Participants
Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 30 mg
n=32 Participants
Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 40 mg
n=33 Participants
Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity
Value at visit Baseline
|
2.83 percentage of maximum activity
Standard Deviation 1.03
|
2.76 percentage of maximum activity
Standard Deviation 0.72
|
2.83 percentage of maximum activity
Standard Deviation 0.95
|
2.51 percentage of maximum activity
Standard Deviation 0.91
|
2.61 percentage of maximum activity
Standard Deviation 0.94
|
2.43 percentage of maximum activity
Standard Deviation 0.57
|
|
Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity
Change from baseline at Week 20
|
-0.19 percentage of maximum activity
Standard Deviation 0.58
|
-0.25 percentage of maximum activity
Standard Deviation 0.51
|
-0.12 percentage of maximum activity
Standard Deviation 0.58
|
-0.08 percentage of maximum activity
Standard Deviation 0.67
|
-0.18 percentage of maximum activity
Standard Deviation 0.57
|
-0.14 percentage of maximum activity
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Baseline, and up to 20 weeks of treatmentPopulation: Per-protocol set (PPS): Included all full analysis set (FAS) population subjects without validity findings for this outcome measure
NT-proBNP = N-terminal pro-hormone b-type natriuretic peptide
Outcome measures
| Measure |
Placebo
n=62 Participants
Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 5 mg
n=21 Participants
Subjects received 5 milligrams (mg) of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 10 mg
n=44 Participants
Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 20 mg
n=39 Participants
Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 30 mg
n=33 Participants
Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 40 mg
n=36 Participants
Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks
|
|---|---|---|---|---|---|---|
|
Measured Values (Log Transformed) and Absolute Change in NT-proBNP From Baseline to 20 Weeks
Absolute change from baseline to Week 20
|
-0.07 log (pg/ml)
Interval -1.3 to 1.6
|
0.08 log (pg/ml)
Interval -3.0 to 0.9
|
0.13 log (pg/ml)
Interval -1.7 to 1.6
|
0.06 log (pg/ml)
Interval -1.2 to 2.3
|
0.09 log (pg/ml)
Interval -1.3 to 0.9
|
0.19 log (pg/ml)
Interval -1.0 to 2.9
|
|
Measured Values (Log Transformed) and Absolute Change in NT-proBNP From Baseline to 20 Weeks
Value at baseline
|
6.80 log (pg/ml)
Interval 4.0 to 8.0
|
6.78 log (pg/ml)
Interval 4.9 to 8.1
|
6.81 log (pg/ml)
Interval 4.8 to 8.2
|
6.73 log (pg/ml)
Interval 5.2 to 8.7
|
6.68 log (pg/ml)
Interval 4.5 to 8.0
|
6.64 log (pg/ml)
Interval 4.1 to 8.8
|
SECONDARY outcome
Timeframe: Baseline, and up to 20 weeks of treatmentPopulation: Per-protocol set (PPS): Included all full analysis set (FAS) population subjects without validity findings for this outcome measure
High sensitivity troponin T (hs-TNT) was measured
Outcome measures
| Measure |
Placebo
n=63 Participants
Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 5 mg
n=22 Participants
Subjects received 5 milligrams (mg) of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 10 mg
n=44 Participants
Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 20 mg
n=38 Participants
Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 30 mg
n=33 Participants
Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 40 mg
n=37 Participants
Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks
|
|---|---|---|---|---|---|---|
|
Measured Values (Log-transformed) and Absolute Change in High Sensitivity Troponin T (Hs-TNT) From Baseline to 20 Weeks
Value at baseline
|
2.92 log(pg/mL)
Interval 1.9 to 4.4
|
3.25 log(pg/mL)
Interval 1.9 to 4.7
|
2.95 log(pg/mL)
Interval 1.9 to 4.7
|
2.76 log(pg/mL)
Interval 1.9 to 4.2
|
2.73 log(pg/mL)
Interval 1.9 to 3.9
|
2.76 log(pg/mL)
Interval 1.9 to 4.8
|
|
Measured Values (Log-transformed) and Absolute Change in High Sensitivity Troponin T (Hs-TNT) From Baseline to 20 Weeks
Absolute change from baseline to Week 20
|
0.00 log(pg/mL)
Interval -1.4 to 1.6
|
0.02 log(pg/mL)
Interval -0.9 to 0.9
|
0.00 log(pg/mL)
Interval -0.7 to 1.1
|
0.12 log(pg/mL)
Interval -0.8 to 1.5
|
0.13 log(pg/mL)
Interval -0.4 to 1.2
|
0.01 log(pg/mL)
Interval -0.8 to 0.9
|
SECONDARY outcome
Timeframe: Baseline, and up to 20 weeks of treatmentPopulation: Per-protocol set (PPS): Included all full analysis set (FAS) population subjects without validity findings for this outcome measure
The KCCQ is the leading health-related quality-of-life measure for patients with chronic heart failure (CHF). It is a 23-item questionnaire that independently measures the impact of patient's heart failure (HF), or its treatment, on 7 distinct domains: 1) Symptom Frequency 2) Symptom Burden 3) Physical Limitation 4) Quality of Life 5) Social Limitations 6) Self-efficacy 7) Symptoms Stability. Overall summary score= mean score of (symptom frequency + symptom burden+ physical limitation + quality of life + social limitation); scores on a scale of 0 to 100, higher scores means better outcome; Physical Limitation: scores on a scale of 0 to 100, higher scores means better outcome; Total symptom score=mean score of (symptom frequency + symptom burden): scores on a scale of 0 to 100, higher scores means better outcome. Positive change means improvement and negative change means deterioration.
Outcome measures
| Measure |
Placebo
n=65 Participants
Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 5 mg
n=22 Participants
Subjects received 5 milligrams (mg) of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 10 mg
n=44 Participants
Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 20 mg
n=41 Participants
Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 30 mg
n=34 Participants
Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks
|
Neladenoson Bialanate 40 mg
n=37 Participants
Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks
|
|---|---|---|---|---|---|---|
|
Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score
Overall Summary Score Baseline
|
69.19 scores on a scale
Standard Deviation 18.02
|
64.75 scores on a scale
Standard Deviation 23.99
|
66.42 scores on a scale
Standard Deviation 21.21
|
64.57 scores on a scale
Standard Deviation 20.73
|
63.67 scores on a scale
Standard Deviation 17.76
|
64.65 scores on a scale
Standard Deviation 18.07
|
|
Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score
Overall Summary Score Change from baseline
|
3.38 scores on a scale
Standard Deviation 13.55
|
7.04 scores on a scale
Standard Deviation 17.24
|
-1.33 scores on a scale
Standard Deviation 20.61
|
3.73 scores on a scale
Standard Deviation 13.03
|
0.27 scores on a scale
Standard Deviation 14.83
|
2.25 scores on a scale
Standard Deviation 14.25
|
|
Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score
Physical Limitation Score Baseline
|
69.07 scores on a scale
Standard Deviation 19.43
|
63.18 scores on a scale
Standard Deviation 25.24
|
68.03 scores on a scale
Standard Deviation 22.79
|
69.35 scores on a scale
Standard Deviation 22.64
|
64.53 scores on a scale
Standard Deviation 22.47
|
63.12 scores on a scale
Standard Deviation 23.44
|
|
Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score
Physical Limitation Score Change from baseline
|
2.18 scores on a scale
Standard Deviation 17.54
|
1.40 scores on a scale
Standard Deviation 17.62
|
-1.34 scores on a scale
Standard Deviation 22.56
|
0.92 scores on a scale
Standard Deviation 14.65
|
-3.75 scores on a scale
Standard Deviation 22.10
|
2.17 scores on a scale
Standard Deviation 17.32
|
|
Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score
Total Symptom Score Baseline
|
76.78 scores on a scale
Standard Deviation 19.64
|
72.25 scores on a scale
Standard Deviation 21.73
|
68.99 scores on a scale
Standard Deviation 23.13
|
69.99 scores on a scale
Standard Deviation 20.18
|
68.00 scores on a scale
Standard Deviation 20.09
|
71.03 scores on a scale
Standard Deviation 18.80
|
|
Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score
Total Symptom Score Change from baseline
|
2.96 scores on a scale
Standard Deviation 15.85
|
5.82 scores on a scale
Standard Deviation 17.51
|
0.14 scores on a scale
Standard Deviation 19.08
|
3.56 scores on a scale
Standard Deviation 14.04
|
2.54 scores on a scale
Standard Deviation 16.79
|
2.62 scores on a scale
Standard Deviation 16.04
|
Adverse Events
Placebo
Serious events: 21 serious events
Other events: 24 other events
Deaths: 2 deaths
Neladenoson Bialanate 5mg
Serious events: 9 serious events
Other events: 13 other events
Deaths: 0 deaths
Neladenoson Bialanate 10mg
Serious events: 11 serious events
Other events: 14 other events
Deaths: 2 deaths
Neladenoson Bialanate 20mg
Serious events: 11 serious events
Other events: 22 other events
Deaths: 1 deaths
Neladenoson Bialanate 30mg
Serious events: 14 serious events
Other events: 17 other events
Deaths: 1 deaths
Neladenoson Bialanate 40mg
Serious events: 16 serious events
Other events: 24 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=76 participants at risk
Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks.
|
Neladenoson Bialanate 5mg
n=27 participants at risk
Subjects received 5 mg of neladenoson bialanate tablets orally for 20 weeks.
|
Neladenoson Bialanate 10mg
n=50 participants at risk
Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks.
|
Neladenoson Bialanate 20mg
n=51 participants at risk
Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks.
|
Neladenoson Bialanate 30mg
n=50 participants at risk
Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks.
|
Neladenoson Bialanate 40mg
n=51 participants at risk
Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
2.6%
2/76 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Eye disorders
Cataract
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Ascites
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Bronchitis
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Otitis media chronic
|
1.3%
1/76 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Pneumonia
|
2.6%
2/76 • Number of events 2 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Wound infection
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Investigations
Arteriogram coronary
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Investigations
Blood glucose increased
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Investigations
Influenza A virus test positive
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
1.3%
1/76 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
4.0%
2/50 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
3.9%
2/51 • Number of events 4 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 2 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/76 • Number of events 4 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Surgical and medical procedures
Insertion of ambulatory peritoneal catheter
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Surgical and medical procedures
Hysterosalpingectomy
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Vascular disorders
Aortic stenosis
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Product Issues
Device dislocation
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
3.9%
2/51 • Number of events 2 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Atrial flutter
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Bradycardia
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardiac arrest
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardiac failure
|
2.6%
2/76 • Number of events 2 • From start of study drug administration up to 26 weeks
|
7.4%
2/27 • Number of events 2 • From start of study drug administration up to 26 weeks
|
6.0%
3/50 • Number of events 3 • From start of study drug administration up to 26 weeks
|
7.8%
4/51 • Number of events 4 • From start of study drug administration up to 26 weeks
|
4.0%
2/50 • Number of events 2 • From start of study drug administration up to 26 weeks
|
13.7%
7/51 • Number of events 8 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
3.9%
3/76 • Number of events 7 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Mitral valve incompetence
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Sinoatrial block
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Tricuspid valve incompetence
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
Other adverse events
| Measure |
Placebo
n=76 participants at risk
Subjects received placebo matched to neladenoson bialanate tablets orally for 20 weeks.
|
Neladenoson Bialanate 5mg
n=27 participants at risk
Subjects received 5 mg of neladenoson bialanate tablets orally for 20 weeks.
|
Neladenoson Bialanate 10mg
n=50 participants at risk
Subjects received 10 mg of neladenoson bialanate tablets orally for 20 weeks.
|
Neladenoson Bialanate 20mg
n=51 participants at risk
Subjects received 20 mg of neladenoson bialanate tablets orally for 20 weeks.
|
Neladenoson Bialanate 30mg
n=50 participants at risk
Subjects received 30 mg of neladenoson bialanate tablets orally for 20 weeks.
|
Neladenoson Bialanate 40mg
n=51 participants at risk
Subjects received 40 mg of neladenoson bialanate tablets orally for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
6.6%
5/76 • Number of events 5 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
6.0%
3/50 • Number of events 3 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
7.8%
4/51 • Number of events 6 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardiac failure
|
6.6%
5/76 • Number of events 5 • From start of study drug administration up to 26 weeks
|
7.4%
2/27 • Number of events 3 • From start of study drug administration up to 26 weeks
|
6.0%
3/50 • Number of events 3 • From start of study drug administration up to 26 weeks
|
11.8%
6/51 • Number of events 9 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
5.9%
3/51 • Number of events 3 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
3.9%
3/76 • Number of events 5 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
7.8%
4/51 • Number of events 4 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.9%
3/76 • Number of events 3 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
4.0%
2/50 • Number of events 2 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
10.0%
5/50 • Number of events 6 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
5.9%
3/51 • Number of events 3 • From start of study drug administration up to 26 weeks
|
6.0%
3/50 • Number of events 3 • From start of study drug administration up to 26 weeks
|
3.9%
2/51 • Number of events 2 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
6.0%
3/50 • Number of events 3 • From start of study drug administration up to 26 weeks
|
3.9%
2/51 • Number of events 2 • From start of study drug administration up to 26 weeks
|
|
General disorders
Fatigue
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
3.9%
2/51 • Number of events 2 • From start of study drug administration up to 26 weeks
|
6.0%
3/50 • Number of events 4 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
5/76 • Number of events 6 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
6.0%
3/50 • Number of events 3 • From start of study drug administration up to 26 weeks
|
5.9%
3/51 • Number of events 3 • From start of study drug administration up to 26 weeks
|
4.0%
2/50 • Number of events 3 • From start of study drug administration up to 26 weeks
|
7.8%
4/51 • Number of events 5 • From start of study drug administration up to 26 weeks
|
|
Investigations
Blood creatinine increased
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
7.8%
4/51 • Number of events 4 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 2 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.9%
3/76 • Number of events 3 • From start of study drug administration up to 26 weeks
|
7.4%
2/27 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
6.0%
3/50 • Number of events 4 • From start of study drug administration up to 26 weeks
|
5.9%
3/51 • Number of events 4 • From start of study drug administration up to 26 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
5.9%
3/51 • Number of events 3 • From start of study drug administration up to 26 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
4/76 • Number of events 5 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
3.9%
2/51 • Number of events 2 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
2/76 • Number of events 2 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
7.8%
4/51 • Number of events 4 • From start of study drug administration up to 26 weeks
|
4.0%
2/50 • Number of events 3 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Dizziness
|
1.3%
1/76 • Number of events 2 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
6.0%
3/50 • Number of events 3 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Renal and urinary disorders
Renal impairment
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 2 • From start of study drug administration up to 26 weeks
|
9.8%
5/51 • Number of events 5 • From start of study drug administration up to 26 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/76 • From start of study drug administration up to 26 weeks
|
7.4%
2/27 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/76 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/27 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
8.0%
4/50 • Number of events 4 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.9%
3/76 • Number of events 3 • From start of study drug administration up to 26 weeks
|
7.4%
2/27 • Number of events 2 • From start of study drug administration up to 26 weeks
|
4.0%
2/50 • Number of events 2 • From start of study drug administration up to 26 weeks
|
9.8%
5/51 • Number of events 6 • From start of study drug administration up to 26 weeks
|
6.0%
3/50 • Number of events 3 • From start of study drug administration up to 26 weeks
|
5.9%
3/51 • Number of events 3 • From start of study drug administration up to 26 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
2/76 • Number of events 2 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
5.9%
3/51 • Number of events 3 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
0.00%
0/51 • From start of study drug administration up to 26 weeks
|
|
Vascular disorders
Hypertension
|
2.6%
2/76 • Number of events 2 • From start of study drug administration up to 26 weeks
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/50 • From start of study drug administration up to 26 weeks
|
7.8%
4/51 • Number of events 6 • From start of study drug administration up to 26 weeks
|
2.0%
1/50 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.0%
1/51 • Number of events 1 • From start of study drug administration up to 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Material for public dissemination will be submitted to the Sponsor for review at least thirty (30) days prior to submission for publication, public dissemination, or review by a publication committee. If Sponsor does not respond within this period Institution and/or the Principal Investigator is/are free to proceed with the intended publication or presentation without further delay
- Publication restrictions are in place
Restriction type: OTHER