Trial Outcomes & Findings for Pilot Study of COR-1 in Heart Failure (NCT NCT01391507)
NCT ID: NCT01391507
Last Updated: 2014-10-17
Results Overview
The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (\>) 55% are considered normal. It was measured by biplane echocardiography (central assessment).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Baseline and Month 6
Results posted on
2014-10-17
Participant Flow
Participant milestones
| Measure |
Placebo
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
6
|
12
|
|
Overall Study
COMPLETED
|
6
|
4
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
4
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
1
|
2
|
Baseline Characteristics
Pilot Study of COR-1 in Heart Failure
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
n=8 Participants
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
n=6 Participants
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
n=12 Participants
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 9.61 • n=93 Participants
|
57.5 years
STANDARD_DEVIATION 10.92 • n=4 Participants
|
62 years
STANDARD_DEVIATION 13.59 • n=27 Participants
|
59.8 years
STANDARD_DEVIATION 11.88 • n=483 Participants
|
59.6 years
STANDARD_DEVIATION 10.97 • n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
|
Region of Enrollment
Germany
|
10 participants
n=93 Participants
|
8 participants
n=4 Participants
|
6 participants
n=27 Participants
|
12 participants
n=483 Participants
|
36 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: Intention-to-treat (ITT) population included all participants who were randomly assigned to treatment. Missing data was imputed using last observation carried forward (LOCF) method.
The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (\>) 55% are considered normal. It was measured by biplane echocardiography (central assessment).
Outcome measures
| Measure |
Placebo
n=10 Participants
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
n=8 Participants
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
n=6 Participants
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
n=12 Participants
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6
Change at Month 6
|
-1.6 Percentage of blood pumped out
Standard Deviation 5.94
|
0.8 Percentage of blood pumped out
Standard Deviation 5.55
|
5.4 Percentage of blood pumped out
Standard Deviation 10.11
|
-0.9 Percentage of blood pumped out
Standard Deviation 3.09
|
|
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6
Baseline
|
35.4 Percentage of blood pumped out
Standard Deviation 11.72
|
29.4 Percentage of blood pumped out
Standard Deviation 12.06
|
35.0 Percentage of blood pumped out
Standard Deviation 13.42
|
32.4 Percentage of blood pumped out
Standard Deviation 10.77
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.
The LVEF is a measure of how much blood is pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (\>) 55% are considered normal. It was measured by biplane echocardiography (local assessment).
Outcome measures
| Measure |
Placebo
n=10 Participants
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
n=8 Participants
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
n=6 Participants
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
n=12 Participants
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9
Baseline
|
32.6 Percentage of blood pumped out
Standard Deviation 5.78
|
33.6 Percentage of blood pumped out
Standard Deviation 9.77
|
35.3 Percentage of blood pumped out
Standard Deviation 8.57
|
32.5 Percentage of blood pumped out
Standard Deviation 9.27
|
|
Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9
Change at Month 9
|
-0.8 Percentage of blood pumped out
Standard Deviation 4.39
|
-1.9 Percentage of blood pumped out
Standard Deviation 5.99
|
3.8 Percentage of blood pumped out
Standard Deviation 4.02
|
-1.8 Percentage of blood pumped out
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.
The NT-ProBNP is a biomarker (a biologic molecule) that has been shown to predict cardiac events.
Outcome measures
| Measure |
Placebo
n=10 Participants
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
n=8 Participants
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
n=6 Participants
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
n=12 Participants
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6
Baseline
|
5678.0 Picogram (pg)/ Milliliter (mL)
Standard Deviation 9347.1
|
2215.9 Picogram (pg)/ Milliliter (mL)
Standard Deviation 1692.1
|
971.4 Picogram (pg)/ Milliliter (mL)
Standard Deviation 665.1
|
2299.4 Picogram (pg)/ Milliliter (mL)
Standard Deviation 2024.1
|
|
Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6
Change at Month 6
|
-805.7 Picogram (pg)/ Milliliter (mL)
Standard Deviation 1241.0
|
1363.4 Picogram (pg)/ Milliliter (mL)
Standard Deviation 3948.7
|
392.8 Picogram (pg)/ Milliliter (mL)
Standard Deviation 295.7
|
1109.6 Picogram (pg)/ Milliliter (mL)
Standard Deviation 2130.6
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. No participants were evaluable for arms COR-1 80 mg and COR-1 160 mg.
Transmitral flow VTI measures how blood flows through the heart. This was measured by echocardiogram. Most of the values for transmitral flow VTI were not provided in the reports from central core echocardiographic laboratory due to technical reasons.
Outcome measures
| Measure |
Placebo
n=2 Participants
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
n=1 Participants
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6
Change at Month 6
|
0.0 Centimeter (cm)
Standard Deviation 0.00
|
0.0 Centimeter (cm)
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
—
|
—
|
|
Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6
Baseline
|
45.0 Centimeter (cm)
Standard Deviation 31.11
|
21.0 Centimeter (cm)
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
Tissue doppler mitral annular velocity is a measure of how well the heart fills with blood. This was measured by echocardiogram. Most of the values for E-wave were not provided in the reports from central core echocardiographic laboratory due to technical reasons.
Outcome measures
| Measure |
Placebo
n=5 Participants
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
n=5 Participants
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
n=1 Participants
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
n=4 Participants
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6
Baseline
|
5.6 Centimeter (cm)/ Second (sec)
Standard Deviation 1.52
|
5.2 Centimeter (cm)/ Second (sec)
Standard Deviation 1.10
|
4.0 Centimeter (cm)/ Second (sec)
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
5.8 Centimeter (cm)/ Second (sec)
Standard Deviation 1.71
|
|
Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6
Change at Month 6
|
-0.2 Centimeter (cm)/ Second (sec)
Standard Deviation 0.45
|
0.0 Centimeter (cm)/ Second (sec)
Standard Deviation 0.00
|
0.0 Centimeter (cm)/ Second (sec)
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
0.0 Centimeter (cm)/ Second (sec)
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.
A standardized 6-minute walk test was performed and the distance covered in 6 minutes was measured.
Outcome measures
| Measure |
Placebo
n=10 Participants
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
n=8 Participants
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
n=6 Participants
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
n=12 Participants
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6
Baseline
|
421.1 Meter
Standard Deviation 113.29
|
451.1 Meter
Standard Deviation 51.02
|
395.2 Meter
Standard Deviation 81.03
|
420.7 Meter
Standard Deviation 109.77
|
|
Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6
Change at Month 6
|
38.7 Meter
Standard Deviation 63.11
|
-8.7 Meter
Standard Deviation 104.35
|
12.8 Meter
Standard Deviation 57.70
|
2.4 Meter
Standard Deviation 41.01
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point.
Disease progression (morbidity) was measured by the NYHA classification. The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of 4 stages. Stage I- No symptoms/limitation in ordinary physical activity (for example, shortness of breath when walking, climbing stairs); Stage II-Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Stage III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity, (for example, walking short distances \[20-100 m\]), comfortable only at rest; and Stage IV- Severe limitations in activity/experiences symptoms while at rest (mostly bedbound participants).
Outcome measures
| Measure |
Placebo
n=10 Participants
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
n=8 Participants
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
n=6 Participants
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
n=12 Participants
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression
Baseline: Stage III (n= 10, 8, 6, 12)
|
3 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression
Baseline: Stage II (n= 10, 8, 6, 12)
|
7 Participants
|
8 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression
Month 6: Stage I (n= 7, 7, 5, 8)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression
Month 6: Stage II (n= 7, 7, 5, 8)
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression
Month 6: Stage III (n= 7, 7, 5, 8)
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
Minnesota living with heart failure questionnaire is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses participant's perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Participants responded to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL.
Outcome measures
| Measure |
Placebo
n=7 Participants
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
n=7 Participants
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
n=5 Participants
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
n=11 Participants
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6
Baseline
|
23.7 Units on a scale
Standard Deviation 11.57
|
21.4 Units on a scale
Standard Deviation 12.09
|
33.2 Units on a scale
Standard Deviation 23.09
|
25.9 Units on a scale
Standard Deviation 25.27
|
|
Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6
Change at Month 6
|
3.3 Units on a scale
Standard Deviation 10.70
|
3.3 Units on a scale
Standard Deviation 16.25
|
1.8 Units on a scale
Standard Deviation 9.50
|
2.4 Units on a scale
Standard Deviation 20.50
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Safety population included all participants who received at least 1 dose of the study agent.
A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Mean heart rate, maximum heart rate and minimum heart rate were evaluated.
Outcome measures
| Measure |
Placebo
n=7 Participants
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
n=7 Participants
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
n=5 Participants
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
n=11 Participants
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6
Change at Month 6: Mean Heart Rate
|
1.3 Beats per minute
Standard Deviation 6.68
|
-0.9 Beats per minute
Standard Deviation 3.63
|
-5.8 Beats per minute
Standard Deviation 10.18
|
1.4 Beats per minute
Standard Deviation 6.97
|
|
Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6
Change at Month 6: Maximum Heart Rate
|
-0.8 Beats per minute
Standard Deviation 15.24
|
5.4 Beats per minute
Standard Deviation 40.15
|
0.0 Beats per minute
Standard Deviation 25.30
|
-2.0 Beats per minute
Standard Deviation 31.56
|
|
Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6
Baseline: Mean Heart Rate
|
74.6 Beats per minute
Standard Deviation 7.00
|
76.9 Beats per minute
Standard Deviation 10.92
|
84.2 Beats per minute
Standard Deviation 11.43
|
75.3 Beats per minute
Standard Deviation 8.59
|
|
Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6
Baseline: Maximum Heart Rate
|
126.4 Beats per minute
Standard Deviation 18.28
|
130.3 Beats per minute
Standard Deviation 33.26
|
123.0 Beats per minute
Standard Deviation 15.26
|
125.1 Beats per minute
Standard Deviation 35.23
|
|
Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6
Baseline: Minimum Heart Rate
|
51.6 Beats per minute
Standard Deviation 11.54
|
59.3 Beats per minute
Standard Deviation 13.12
|
66.0 Beats per minute
Standard Deviation 4.16
|
58.7 Beats per minute
Standard Deviation 6.65
|
|
Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6
Change at Month 6: Minimum Heart Rate
|
0.5 Beats per minute
Standard Deviation 3.39
|
0.1 Beats per minute
Standard Deviation 3.93
|
-7.8 Beats per minute
Standard Deviation 4.50
|
-2.3 Beats per minute
Standard Deviation 10.09
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Safety population included all participants who received at least 1 dose of the study agent.
A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Block, Heart rhythm, AV junctional, Ventricular, Lown classification, Results were evaluated.
Outcome measures
| Measure |
Placebo
n=7 Participants
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
n=7 Participants
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
n=5 Participants
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
n=11 Participants
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: AV block II
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: Atrial fibrillation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: Atrial fibrillation-paroxysmal/persistent
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: Other
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: Ventricular, 1001-2400/24h
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: Abnormal, NCS
|
6 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: Abnormal, CS
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: No block
|
7 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: AV block I
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: AV block III
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: Sinus rhythm
|
5 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: Atrial fibrillation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline:Atrial fibrillation-paroxysmal/persistent
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: Other
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline; AV junctional, 0-240/24h
|
5 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: AV junctional, 241-1000/24h
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: AV junctional, 1001-2400/24h
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: Ventricular, 0-240/24h
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: Ventricular, 241-1000/24h
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: Ventricular, 1001-2400/24h
|
4 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: 0 No VES
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: I Occasional individual VES (< 30/h)
|
3 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: II Frequent VES (>30/h)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: IIIa Polymorphous VES
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: IIIb Ventricular bigeminy
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: IVa Couplets, repetitive VES
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: IVb Runs, repetitive VES
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: V Early occurring VES(R-on T phenomenon)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: II, IIIa, IVa, IVb
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: Normal
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: Abnormal, NCS
|
5 Participants
|
5 Participants
|
1 Participants
|
8 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Baseline: Abnormal, CS
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: No block
|
6 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: AV block I
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: AV block II
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: AV block III
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: Sinus rhythm
|
2 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: AV junctional, 0-240/24h
|
5 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: AV junctional, 241-1000/24h
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: AV junctional, 1001-2400/24h
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: Ventricular, 0-240/24h
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: Ventricular, 241-1000/24h
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: 0 No VES
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: I Occasional individual VES (< 30/h)
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: II Frequent VES (>30/h)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: IIIa Polymorphous VES
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: IVa Couplets, repetitive VES
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: IVb Runs, repetitive VES
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: V Early occurring VES (R-on T phenomenon)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: II, IIIa, IVa, IVb
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Holter Electrocardiography (ECG) Parameters
Month 6: Normal
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
COR-1 20 Milligram (mg)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
COR-1 80 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
COR-1 160 mg
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
n=8 participants at risk
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
n=6 participants at risk
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
n=12 participants at risk
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac Failure
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
16.7%
1/6 • 9 months
|
16.7%
2/12 • 9 months
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Cardiac disorders
Heart Valve Incompetence
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Cardiac disorders
Sinus Arrest
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
General disorders
Cardiac Death
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Investigations
Ejection Fraction Decreased
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Investigations
Weight Increased
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Psychiatric disorders
Mental Disorder
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Surgical and medical procedures
Haemodialysis
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 20 Milligram (mg)
n=8 participants at risk
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 80 mg
n=6 participants at risk
COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
COR-1 160 mg
n=12 participants at risk
COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
|
|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Cardiac disorders
Cardiac Failure
|
10.0%
1/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Gastrointestinal disorders
Anal Inflammation
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
16.7%
2/12 • 9 months
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
16.7%
1/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
General disorders
Asthenia
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
General disorders
Chest Pain
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
General disorders
Fatigue
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
General disorders
Injection Site Haematoma
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
General disorders
Oedema Peripheral
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
33.3%
2/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
General disorders
Pyrexia
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
16.7%
1/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Infections and infestations
Acute Tonsillitis
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Infections and infestations
Cystitis
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
33.3%
2/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Infections and infestations
Respiratory Tract Infection
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
16.7%
1/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
16.7%
1/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Injury, poisoning and procedural complications
Face Injury
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Injury, poisoning and procedural complications
Overdose
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Investigations
Blood Creatine Increased
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Investigations
Blood Potassium Increased
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Investigations
Blood Pressure Decreased
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Investigations
Carotid Bruit
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
16.7%
1/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Investigations
Glomerular Filtration Rate Abnormal
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
16.7%
1/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Investigations
Heart Rate Increased
|
10.0%
1/10 • 9 months
|
12.5%
1/8 • 9 months
|
16.7%
1/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
16.7%
1/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Investigations
Prostatic Specific Antigen Increased
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Investigations
Weight Increased
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
16.7%
1/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
16.7%
1/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
16.7%
1/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Nervous system disorders
Aura
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
16.7%
1/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Nervous system disorders
Sciatica
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Psychiatric disorders
Mental Disorder
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Renal and urinary disorders
Renal Impairment
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
16.7%
1/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
16.7%
2/12 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • 9 months
|
12.5%
1/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
|
Surgical and medical procedures
Wisdom Teeth Removal
|
0.00%
0/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
8.3%
1/12 • 9 months
|
|
Vascular disorders
Venous Insufficiency
|
10.0%
1/10 • 9 months
|
0.00%
0/8 • 9 months
|
0.00%
0/6 • 9 months
|
0.00%
0/12 • 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If Sponsor should have justified objections, then Hospital will respond to these objections as the scientific nature of publication are not negatively affected. If no agreement can be reached, they will appeal to an independent body of experts to resolve the points in dispute. It is not permissible to publish study data before overall study results are published without the written consent of Sponsor. However, this applies to a maximum period of 12 months after study has ended or been cancelled.
- Publication restrictions are in place
Restriction type: OTHER