Trial Outcomes & Findings for AZD8601 Study in CABG Patients (NCT NCT03370887)
NCT ID: NCT03370887
Last Updated: 2024-10-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
From baseline to end of follow up at 6 months
Results posted on
2024-10-10
Participant Flow
This study was conducted at 4 clinical research centers in Finland and Germany First subject enrolled (First subject first visit/first consent signed date): 2018. Last subject last visit: 2021.
The study was to include two dose cohorts, which were to receive a total dose of 3 or 30 mg ofAZD8601. However, due to low recruitment levels, only 7 participants receiving a total dose of 3 mg AZD8601 and 4 participants receiving placebo completed dosing, according to the randomisation scheme
Participant milestones
| Measure |
AZD8601 3mg
AZD8601 3mg
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AZD8601 Study in CABG Patients
Baseline characteristics by cohort
| Measure |
AZD8601 3mg
n=7 Participants
AZD8601 3mg
|
Placebo
n=4 Participants
Placebo
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.3 Years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
67.8 Years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
68.1 Years
STANDARD_DEVIATION 7.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsOutcome measures
| Measure |
AZD8601 3 mg
n=7 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With Adverse Events
|
7 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsOutcome measures
| Measure |
AZD8601 3 mg
n=7 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Pulse Rate (Vital Sign)
Baseline
|
63.1 beats/min
Standard Deviation 10.42
|
62.6 beats/min
Standard Deviation 6.04
|
|
Pulse Rate (Vital Sign)
Day 1
|
81.3 beats/min
Standard Deviation 7.38
|
75.2 beats/min
Standard Deviation 4.20
|
|
Pulse Rate (Vital Sign)
Day 2
|
85.2 beats/min
Standard Deviation 5.54
|
81.1 beats/min
Standard Deviation 7.01
|
|
Pulse Rate (Vital Sign)
Day 3
|
83.6 beats/min
Standard Deviation 8.38
|
82.4 beats/min
Standard Deviation 6.80
|
|
Pulse Rate (Vital Sign)
Day 4
|
81.9 beats/min
Standard Deviation 14.54
|
75.3 beats/min
Standard Deviation 7.63
|
|
Pulse Rate (Vital Sign)
Visit 5 (Day 30)
|
74.3 beats/min
Standard Deviation 13.33
|
65.5 beats/min
Standard Deviation 6.81
|
|
Pulse Rate (Vital Sign)
Visit 6 (Day 91)
|
66.9 beats/min
Standard Deviation 15.05
|
70.8 beats/min
Standard Deviation 7.18
|
|
Pulse Rate (Vital Sign)
Visit 7 (Day 182)
|
63.6 beats/min
Standard Deviation 15.62
|
61.0 beats/min
Standard Deviation 2.16
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsOutcome measures
| Measure |
AZD8601 3 mg
n=7 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With an ECG Determined to be Abnormal and Clinically Significant
Baseline
|
0 Participants
|
0 Participants
|
|
Number of Subjects With an ECG Determined to be Abnormal and Clinically Significant
End of treatment
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=6 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Leukocytes, Particle Concentration
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Leukocytes, Particle Concentration
Maximum value during treatment
|
3 Number of subjects
|
1 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: No SD calculated when only one subject in group
Outcome measures
| Measure |
AZD8601 3 mg
n=7 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Oxygen Saturation (Vital Sign)
Baseline
|
96.0 Percent
|
100.0 Percent
|
|
Oxygen Saturation (Vital Sign)
Day 1
|
97.6 Percent
Standard Deviation 4.46
|
99.3 Percent
Standard Deviation 0.80
|
|
Oxygen Saturation (Vital Sign)
Day 2
|
97.7 Percent
Standard Deviation 1.68
|
97.4 Percent
Standard Deviation 2.42
|
|
Oxygen Saturation (Vital Sign)
Day 3
|
95.6 Percent
Standard Deviation 2.14
|
96.6 Percent
Standard Deviation 3.60
|
|
Oxygen Saturation (Vital Sign)
Day 4
|
95.7 Percent
Standard Deviation 1.85
|
95.8 Percent
Standard Deviation 3.74
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsOutcome measures
| Measure |
AZD8601 3 mg
n=7 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Systolic Blood Pressure (Vital Sign)
Baseline
|
141.1 mmHg
Standard Deviation 24.42
|
141.7 mmHg
Standard Deviation 23.32
|
|
Systolic Blood Pressure (Vital Sign)
Day 1
|
113.5 mmHg
Standard Deviation 5.67
|
116.8 mmHg
Standard Deviation 12.53
|
|
Systolic Blood Pressure (Vital Sign)
Day 2
|
118.1 mmHg
Standard Deviation 11.98
|
104.8 mmHg
Standard Deviation 4.39
|
|
Systolic Blood Pressure (Vital Sign)
Day 3
|
118.5 mmHg
Standard Deviation 8.04
|
100.8 mmHg
Standard Deviation 10.82
|
|
Systolic Blood Pressure (Vital Sign)
Day 4
|
129.1 mmHg
Standard Deviation 16.63
|
109.0 mmHg
Standard Deviation 6.48
|
|
Systolic Blood Pressure (Vital Sign)
Visit 5 (Day 30)
|
135.9 mmHg
Standard Deviation 17.56
|
134.5 mmHg
Standard Deviation 29.49
|
|
Systolic Blood Pressure (Vital Sign)
Visit 6 (Day 91)
|
146.3 mmHg
Standard Deviation 11.76
|
163.0 mmHg
Standard Deviation 35.39
|
|
Systolic Blood Pressure (Vital Sign)
Visit 7 (Day 182)
|
142.3 mmHg
Standard Deviation 13.00
|
147.3 mmHg
Standard Deviation 34.07
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Erythrocytes, Particle Concentration
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Erythrocytes, Particle Concentration
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsOutcome measures
| Measure |
AZD8601 3 mg
n=7 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Diastolic Blood Pressure (Vital Sign)
Baseline
|
82.1 mmHg
Standard Deviation 17.95
|
74.5 mmHg
Standard Deviation 23.57
|
|
Diastolic Blood Pressure (Vital Sign)
Day 1
|
59.2 mmHg
Standard Deviation 6.52
|
62.0 mmHg
Standard Deviation 7.63
|
|
Diastolic Blood Pressure (Vital Sign)
Day 2
|
59.2 mmHg
Standard Deviation 10.62
|
58.0 mmHg
Standard Deviation 5.12
|
|
Diastolic Blood Pressure (Vital Sign)
Day 3
|
63.7 mmHg
Standard Deviation 8.64
|
56.9 mmHg
Standard Deviation 2.83
|
|
Diastolic Blood Pressure (Vital Sign)
Day 4
|
73.7 mmHg
Standard Deviation 11.07
|
66.8 mmHg
Standard Deviation 5.91
|
|
Diastolic Blood Pressure (Vital Sign)
Visit 5 (Day 30)
|
78.1 mmHg
Standard Deviation 10.16
|
83.5 mmHg
Standard Deviation 14.55
|
|
Diastolic Blood Pressure (Vital Sign)
Visit 6 (Day 91)
|
80.0 mmHg
Standard Deviation 7.09
|
93.8 mmHg
Standard Deviation 16.62
|
|
Diastolic Blood Pressure (Vital Sign)
Visit 7 (Day 182)
|
79.4 mmHg
Standard Deviation 8.06
|
83.5 mmHg
Standard Deviation 19.60
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=6 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Erythrocyte, Volume Fraction
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Erythrocyte, Volume Fraction
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=6 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Erythrocytes, Mean Cell Volume
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Erythrocytes, Mean Cell Volume
Maximum value during treatment
|
1 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=6 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Hemoglobin
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Hemoglobin
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Neutrophils
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Neutrophils
Maximum value during treatment
|
2 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Lymphocytes
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Lymphocytes
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Monocytes
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Monocytes
Maximum value during treatment
|
0 Number of subjects
|
1 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Eosinophils
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Eosinophils
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Basophils
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Basophils
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=6 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Platelets
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Platelets
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=2 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Reticulocytes
Baseline
|
1 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects With High Values of Reticulocytes
Maximum value during treatment
|
1 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=4 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Prothrombin Complex INR
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Prothrombin Complex INR
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=4 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Activated Partial Thromboplastin Time
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Activated Partial Thromboplastin Time
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=3 Participants
AZD8601 3 mg
|
Placebo
n=3 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Fibrinogen
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Fibrinogen
Maximum value during treatment
|
3 Number of subjects
|
2 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=6 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Sodium
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Sodium
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=6 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Potassium
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Potassium
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=4 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Urea
Baseline
|
0 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects With High Values of Urea
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Creatinine
Baseline
|
1 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects With High Values of Creatinine
Maximum value during treatment
|
1 Number of subjects
|
1 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Albumin
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Albumin
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Calcium
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Calcium
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=4 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Phosphate
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Phosphate
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Alkaline Phosphatase
Baseline
|
0 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects With High Values of Alkaline Phosphatase
Maximum value during treatment
|
0 Number of subjects
|
1 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Alanine Aminotransferase
Baseline
|
0 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects With High Values of Alanine Aminotransferase
Maximum value during treatment
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Aspartate Aminotransferase
Baseline
|
1 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects With High Values of Aspartate Aminotransferase
Maximum value during treatment
|
0 Number of subjects
|
1 Number of subjects
|
PRIMARY outcome
Timeframe: From baseline to end of follow up at 6 monthsPopulation: For some participants laboratory analysis have not been made
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Outcome measures
| Measure |
AZD8601 3 mg
n=5 Participants
AZD8601 3 mg
|
Placebo
n=4 Participants
Placebo
|
|---|---|---|
|
Number of Subjects With High Values of Bilirubin, Total
Baseline
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects With High Values of Bilirubin, Total
Maximum value during treatment
|
1 Number of subjects
|
0 Number of subjects
|
Adverse Events
AZD8601 3mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD8601 3mg
n=7 participants at risk
AZD8601 3mg
|
Placebo
n=4 participants at risk
Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Injury, poisoning and procedural complications
Incision site impaired healing
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Injury, poisoning and procedural complications
Incision site inflammation
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Nervous system disorders
Embolic cerebral infarction
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/7 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
25.0%
1/4 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
Other adverse events
| Measure |
AZD8601 3mg
n=7 participants at risk
AZD8601 3mg
|
Placebo
n=4 participants at risk
Placebo
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Eye disorders
Cataract
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
General disorders
Chest pain
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
General disorders
Feeling cold
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
25.0%
1/4 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
25.0%
1/4 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
25.0%
1/4 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Infections and infestations
Wound infection
|
0.00%
0/7 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
25.0%
1/4 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
50.0%
2/4 • Number of events 2 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/7 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
25.0%
1/4 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Investigations
Liver function test increased
|
0.00%
0/7 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
25.0%
1/4 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/7 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
25.0%
1/4 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
25.0%
1/4 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
25.0%
1/4 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Nervous system disorders
Embolic cerebral infarction
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Nervous system disorders
Syncope
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
25.0%
1/4 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
25.0%
1/4 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
50.0%
2/4 • Number of events 2 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Cardiac disorders
Atrial fibrillation
|
28.6%
2/7 • Number of events 2 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
50.0%
2/4 • Number of events 2 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Cardiac disorders
Left ventricular dysfunction
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Cardiac disorders
Sinus bradycardia
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Cardiac disorders
Tachycardia
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Cardiac disorders
Ventricular arrhythmia
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
|
Cardiac disorders
Ventricular extrasystoles
|
14.3%
1/7 • Number of events 1 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
0.00%
0/4 • All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60