Trial Outcomes & Findings for A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (NCT NCT02338843)
NCT ID: NCT02338843
Last Updated: 2018-03-27
Results Overview
Response with respect to mean arterial pressure (MAP) at hour 3 after the start of infusion was defined as an increase from baseline of at least 10 mm Hg or an increase to at least 75 mm Hg, without an increase in the dose of background vasopressors.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
344 participants
Primary outcome timeframe
Hour 3
Results posted on
2018-03-27
Participant Flow
Participant milestones
| Measure |
LJPC-501 (Angiotensin II)
Treatment arm Injection for Intravenous Infusion
|
Placebo (0.9% Sodium Chloride Solution)
Placebo arm Volume matched saline administered via intravenous infusion
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
158
|
|
Overall Study
COMPLETED
|
119
|
100
|
|
Overall Study
NOT COMPLETED
|
44
|
58
|
Reasons for withdrawal
| Measure |
LJPC-501 (Angiotensin II)
Treatment arm Injection for Intravenous Infusion
|
Placebo (0.9% Sodium Chloride Solution)
Placebo arm Volume matched saline administered via intravenous infusion
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Death
|
40
|
53
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Subject Recovered
|
0
|
2
|
|
Overall Study
Discontinued prior to randomizat
|
1
|
0
|
Baseline Characteristics
BMI could not be calculated for two patients in the treatment group and three patients in the placebo group.
Baseline characteristics by cohort
| Measure |
LJPC-501 (Angiotensin II)
n=163 Participants
Treatment arm
LJPC-501: Treatment arm
|
Placebo (0.9% Sodium Chloride Solution)
n=158 Participants
Placebo arm
Placebo: PBO
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Cause of Shock
Other
|
6 Participants
n=163 Participants
|
4 Participants
n=158 Participants
|
10 Participants
n=321 Participants
|
|
Age, Continuous
|
63 years
n=163 Participants
|
65 years
n=158 Participants
|
64 years
n=321 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=163 Participants
|
55 Participants
n=158 Participants
|
126 Participants
n=321 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=163 Participants
|
103 Participants
n=158 Participants
|
195 Participants
n=321 Participants
|
|
Region of Enrollment
New Zealand
|
4 Participants
n=163 Participants
|
5 Participants
n=158 Participants
|
9 Participants
n=321 Participants
|
|
Region of Enrollment
Canada
|
26 Participants
n=163 Participants
|
10 Participants
n=158 Participants
|
36 Participants
n=321 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=163 Participants
|
1 Participants
n=158 Participants
|
1 Participants
n=321 Participants
|
|
Region of Enrollment
United States
|
90 Participants
n=163 Participants
|
110 Participants
n=158 Participants
|
200 Participants
n=321 Participants
|
|
Region of Enrollment
Finland
|
5 Participants
n=163 Participants
|
2 Participants
n=158 Participants
|
7 Participants
n=321 Participants
|
|
Region of Enrollment
United Kingdom
|
9 Participants
n=163 Participants
|
9 Participants
n=158 Participants
|
18 Participants
n=321 Participants
|
|
Region of Enrollment
Australia
|
24 Participants
n=163 Participants
|
19 Participants
n=158 Participants
|
43 Participants
n=321 Participants
|
|
Region of Enrollment
France
|
5 Participants
n=163 Participants
|
1 Participants
n=158 Participants
|
6 Participants
n=321 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=163 Participants
|
1 Participants
n=158 Participants
|
1 Participants
n=321 Participants
|
|
Body Mass Index (BMI)
BMI ≥ 30
|
69 Participants
n=161 Participants • BMI could not be calculated for two patients in the treatment group and three patients in the placebo group.
|
71 Participants
n=155 Participants • BMI could not be calculated for two patients in the treatment group and three patients in the placebo group.
|
140 Participants
n=316 Participants • BMI could not be calculated for two patients in the treatment group and three patients in the placebo group.
|
|
Body Mass Index (BMI)
BMI < 30
|
92 Participants
n=161 Participants • BMI could not be calculated for two patients in the treatment group and three patients in the placebo group.
|
84 Participants
n=155 Participants • BMI could not be calculated for two patients in the treatment group and three patients in the placebo group.
|
176 Participants
n=316 Participants • BMI could not be calculated for two patients in the treatment group and three patients in the placebo group.
|
|
Mean Arterial Pressure (MAP)
|
66.3 mmHg
n=163 Participants
|
66.3 mmHg
n=158 Participants
|
66.3 mmHg
n=321 Participants
|
|
APACHE II Score
|
27 points
n=163 Participants
|
29 points
n=158 Participants
|
28 points
n=321 Participants
|
|
Vasopressor Dose
|
0.33 mcg/kg/min
n=163 Participants
|
0.34 mcg/kg/min
n=158 Participants
|
0.34 mcg/kg/min
n=321 Participants
|
|
Cause of Shock
Sepsis
|
127 Participants
n=163 Participants
|
132 Participants
n=158 Participants
|
259 Participants
n=321 Participants
|
|
Cause of Shock
Other, potentially sepsis
|
20 Participants
n=163 Participants
|
11 Participants
n=158 Participants
|
31 Participants
n=321 Participants
|
|
Cause of Shock
Pancreatitis
|
0 Participants
n=163 Participants
|
2 Participants
n=158 Participants
|
2 Participants
n=321 Participants
|
|
Cause of Shock
Vasoplegia
|
10 Participants
n=163 Participants
|
9 Participants
n=158 Participants
|
19 Participants
n=321 Participants
|
PRIMARY outcome
Timeframe: Hour 3Response with respect to mean arterial pressure (MAP) at hour 3 after the start of infusion was defined as an increase from baseline of at least 10 mm Hg or an increase to at least 75 mm Hg, without an increase in the dose of background vasopressors.
Outcome measures
| Measure |
LJPC-501 (Angiotensin II)
n=163 Participants
Treatment arm
LJPC-501: Treatment arm
|
Placebo (0.9% Sodium Chloride Solution)
n=158 Participants
Placebo arm
Placebo: PBO
|
|---|---|---|
|
An Increased MAP, Defined as Achievement of a Day 1 MAP at 3 Hours Following the Initiation of Study Drug, of ≥ 75 mmHg OR a 10 mmHg Increase in Baseline MAP
|
114 Participants
|
37 Participants
|
Adverse Events
LJPC-501 (Angiotensin II)
Serious events: 99 serious events
Other events: 110 other events
Deaths: 75 deaths
Placebo (0.9% Sodium Chloride Solution)
Serious events: 106 serious events
Other events: 108 other events
Deaths: 85 deaths
Serious adverse events
| Measure |
LJPC-501 (Angiotensin II)
n=163 participants at risk
Treatment arm
LJPC-501: Treatment arm
|
Placebo (0.9% Sodium Chloride Solution)
n=158 participants at risk
Placebo arm
Placebo: PBO
|
|---|---|---|
|
Infections and infestations
Abdominal abscess
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Abdominal infection
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Cardiac valve vegetation
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Clostridium difficile sepsis
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Liver abscess
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Necrotising fasciitis
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Pneumonia
|
1.2%
2/163 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
1.9%
3/158 • Number of events 3 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Pulmonary sepsis
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Sepsis
|
1.8%
3/163 • Number of events 3 • Adverse events were collected from study drug initiation through Day 28.
|
1.3%
2/158 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Septic shock
|
11.0%
18/163 • Number of events 18 • Adverse events were collected from study drug initiation through Day 28.
|
6.3%
10/158 • Number of events 10 • Adverse events were collected from study drug initiation through Day 28.
|
|
Infections and infestations
Tracheobronchitis
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell leukaemia
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.2%
2/163 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Psychiatric disorders
Mental status change
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Brain hypoxia
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Brain injury
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
1.3%
2/158 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
1.3%
2/158 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Cerebral infarction
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Depressed level of conciousness
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Hemiparesis
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Ischaemic stroke
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Nervous system disorders
Toxic leukoencephalopathy
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
2/163 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
1.3%
2/158 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Arrhythmia
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
5/163 • Number of events 5 • Adverse events were collected from study drug initiation through Day 28.
|
3.2%
5/158 • Number of events 5 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Atrioventricular block
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Bradycardia
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
1.3%
2/158 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Cardiac arrest
|
4.3%
7/163 • Number of events 10 • Adverse events were collected from study drug initiation through Day 28.
|
5.7%
9/158 • Number of events 10 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.8%
3/163 • Number of events 3 • Adverse events were collected from study drug initiation through Day 28.
|
3.2%
5/158 • Number of events 5 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Cardiogenic shock
|
1.2%
2/163 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
2.5%
4/158 • Number of events 4 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
2.5%
4/158 • Number of events 4 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Tachycardia
|
1.2%
2/163 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Ventricular fibrillation
|
1.2%
2/163 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Ventricular tachycardia
|
3.1%
5/163 • Number of events 5 • Adverse events were collected from study drug initiation through Day 28.
|
1.9%
3/158 • Number of events 3 • Adverse events were collected from study drug initiation through Day 28.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
3/163 • Number of events 3 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Vascular disorders
Distributive shock
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
2.5%
4/158 • Number of events 4 • Adverse events were collected from study drug initiation through Day 28.
|
|
Vascular disorders
Hypotension
|
3.1%
5/163 • Number of events 5 • Adverse events were collected from study drug initiation through Day 28.
|
1.9%
3/158 • Number of events 3 • Adverse events were collected from study drug initiation through Day 28.
|
|
Vascular disorders
Peripheral ischaemia
|
3.1%
5/163 • Number of events 5 • Adverse events were collected from study drug initiation through Day 28.
|
1.9%
3/158 • Number of events 3 • Adverse events were collected from study drug initiation through Day 28.
|
|
Vascular disorders
Shock
|
1.8%
3/163 • Number of events 3 • Adverse events were collected from study drug initiation through Day 28.
|
1.9%
3/158 • Number of events 3 • Adverse events were collected from study drug initiation through Day 28.
|
|
Vascular disorders
Shock haemorrhagic
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Vascular disorders
Vasospasm
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
1.3%
2/158 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.8%
3/163 • Number of events 3 • Adverse events were collected from study drug initiation through Day 28.
|
3.2%
5/158 • Number of events 5 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchomalacia
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
1.9%
3/158 • Number of events 3 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
1.3%
2/158 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.9%
8/163 • Number of events 8 • Adverse events were collected from study drug initiation through Day 28.
|
7.0%
11/158 • Number of events 11 • Adverse events were collected from study drug initiation through Day 28.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Gastrointestinal disorders
Gastrointestinal mucosal exfoliation
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Gastrointestinal disorders
Haematemesis
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
1.9%
3/158 • Number of events 3 • Adverse events were collected from study drug initiation through Day 28.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Hepatobiliary disorders
Hepatic vascular thrombosis
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Hepatobiliary disorders
Liver disorder
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Musculoskeletal and connective tissue disorders
Muscle necrosis
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Renal and urinary disorders
Renal failure
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Renal and urinary disorders
Renal impairment
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
General disorders
Device dislocation
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
General disorders
Hypothermia
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
General disorders
Medical device complication
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
General disorders
Multi-organ failure
|
15.3%
25/163 • Number of events 25 • Adverse events were collected from study drug initiation through Day 28.
|
14.6%
23/158 • Number of events 23 • Adverse events were collected from study drug initiation through Day 28.
|
|
General disorders
Pyrexia
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Investigations
Alanine aminotransferase increased
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Investigations
Blood lactic acid increased
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Investigations
Liver function test abnormal
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Investigations
Staphylococcus test positive
|
0.61%
1/163 • Number of events 2 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.61%
1/163 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
0.00%
0/158 • Adverse events were collected from study drug initiation through Day 28.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/163 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
Other adverse events
| Measure |
LJPC-501 (Angiotensin II)
n=163 participants at risk
Treatment arm
LJPC-501: Treatment arm
|
Placebo (0.9% Sodium Chloride Solution)
n=158 participants at risk
Placebo arm
Placebo: PBO
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
11/163 • Number of events 11 • Adverse events were collected from study drug initiation through Day 28.
|
5.7%
9/158 • Number of events 9 • Adverse events were collected from study drug initiation through Day 28.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.2%
15/163 • Number of events 15 • Adverse events were collected from study drug initiation through Day 28.
|
6.3%
10/158 • Number of events 10 • Adverse events were collected from study drug initiation through Day 28.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.0%
13/163 • Number of events 14 • Adverse events were collected from study drug initiation through Day 28.
|
6.3%
10/158 • Number of events 10 • Adverse events were collected from study drug initiation through Day 28.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.7%
6/163 • Number of events 6 • Adverse events were collected from study drug initiation through Day 28.
|
7.0%
11/158 • Number of events 11 • Adverse events were collected from study drug initiation through Day 28.
|
|
Psychiatric disorders
Agitation
|
3.7%
6/163 • Number of events 6 • Adverse events were collected from study drug initiation through Day 28.
|
5.1%
8/158 • Number of events 8 • Adverse events were collected from study drug initiation through Day 28.
|
|
Psychiatric disorders
Delirium
|
5.5%
9/163 • Number of events 9 • Adverse events were collected from study drug initiation through Day 28.
|
0.63%
1/158 • Number of events 1 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Atrial fibrillation
|
10.4%
17/163 • Number of events 18 • Adverse events were collected from study drug initiation through Day 28.
|
10.1%
16/158 • Number of events 18 • Adverse events were collected from study drug initiation through Day 28.
|
|
Cardiac disorders
Bradycardia
|
3.7%
6/163 • Number of events 6 • Adverse events were collected from study drug initiation through Day 28.
|
5.7%
9/158 • Number of events 9 • Adverse events were collected from study drug initiation through Day 28.
|
|
Vascular disorders
Hypertension
|
5.5%
9/163 • Number of events 11 • Adverse events were collected from study drug initiation through Day 28.
|
5.7%
9/158 • Number of events 9 • Adverse events were collected from study drug initiation through Day 28.
|
|
Vascular disorders
Hypotension
|
8.0%
13/163 • Number of events 16 • Adverse events were collected from study drug initiation through Day 28.
|
4.4%
7/158 • Number of events 7 • Adverse events were collected from study drug initiation through Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.9%
8/163 • Number of events 8 • Adverse events were collected from study drug initiation through Day 28.
|
5.1%
8/158 • Number of events 8 • Adverse events were collected from study drug initiation through Day 28.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.9%
8/163 • Number of events 8 • Adverse events were collected from study drug initiation through Day 28.
|
6.3%
10/158 • Number of events 11 • Adverse events were collected from study drug initiation through Day 28.
|
Additional Information
George Tidmarsh, MD, PhD
La Jolla Pharmaceutical Company
Phone: 858-207-4264
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All investigators were restricted from publishing individual papers until the study-wide publication was published. After this time, investigator restrictions varied by institution.
- Publication restrictions are in place
Restriction type: OTHER