A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (ATHOS-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02338843

Recruitment Status : Completed

First Posted : January 14, 2015

Results First Posted : January 17, 2018

Last Update Posted : March 27, 2018

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

La Jolla Pharmaceutical Company

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions	Catecholamine-resistant Hypotension (CRH) Distributive Shock High Output Shock Sepsis
Interventions	Drug: LJPC-501 Drug: Placebo
Enrollment	344

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	LJPC-501 (Angiotensin II)	Placebo (0.9% Sodium Chloride Solution)
Arm/Group Description	Treatment arm Injection for Intrave...	Placebo arm Volume matched saline a...
Arm/Group Description	Treatment arm Injection for Intravenous Infusion	Placebo arm Volume matched saline administered via intravenous infusion
Period Title: Overall Study
Started ^[1]	163	158
Completed	119	100
Not Completed	44	58
Reason Not Completed
Adverse Event	2	1
Death	40	53
Physician Decision	1	0
Withdrawal by Subject	0	2
Subject Recovered	0	2
Discontinued prior to randomizat	1	0
[1] Discrepancy between enrollment and started numbers due to 23 pts who enrolled but were not treated.

Baseline Characteristics

Arm/Group Title		LJPC-501 (Angiotensin II)	Placebo (0.9% Sodium Chloride Solution)	Total
Arm/Group Description		Treatment arm ...	Placebo arm	Total of all reporting groups
Arm/Group Description		Treatment arm LJPC-501: Treatment arm	Placebo arm Placebo: PBO	Total of all reporting groups
Overall Number of Baseline Participants		163	158	321
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Inter-Quartile Range) Unit of measure: Years
	Number Analyzed	163 participants	158 participants	321 participants
		63 (52 to 75)	65 (53 to 75)	64 (52 to 75)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	163 participants	158 participants	321 participants
	Female	71 43.6%	55 34.8%	126 39.3%
	Male	92 56.4%	103 65.2%	195 60.7%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants
New Zealand	Number Analyzed	163 participants	158 participants	321 participants
New Zealand		4 2.5%	5 3.2%	9 2.8%
Canada	Number Analyzed	163 participants	158 participants	321 participants
Canada		26 16.0%	10 6.3%	36 11.2%
Belgium	Number Analyzed	163 participants	158 participants	321 participants
Belgium		0 0.0%	1 0.6%	1 0.3%
United States	Number Analyzed	163 participants	158 participants	321 participants
United States		90 55.2%	110 69.6%	200 62.3%
Finland	Number Analyzed	163 participants	158 participants	321 participants
Finland		5 3.1%	2 1.3%	7 2.2%
United Kingdom	Number Analyzed	163 participants	158 participants	321 participants
United Kingdom		9 5.5%	9 5.7%	18 5.6%
Australia	Number Analyzed	163 participants	158 participants	321 participants
Australia		24 14.7%	19 12.0%	43 13.4%
France	Number Analyzed	163 participants	158 participants	321 participants
France		5 3.1%	1 0.6%	6 1.9%
Germany	Number Analyzed	163 participants	158 participants	321 participants
Germany		0 0.0%	1 0.6%	1 0.3%
Body Mass Index (BMI) ^[1] Measure Type: Count of Participants Unit of measure: Participants
BMI ≥ 30	Number Analyzed	161 participants	155 participants	316 participants
BMI ≥ 30		69 42.9%	71 45.8%	140 44.3%
BMI < 30	Number Analyzed	161 participants	155 participants	316 participants
BMI < 30		92 57.1%	84 54.2%	176 55.7%
		[1] Measure Analysis Population Description: BMI could not be calculated for two patients in the treatment group and three patients in the placebo group.
Mean Arterial Pressure (MAP) Median (Inter-Quartile Range) Unit of measure: mmHg
	Number Analyzed	163 participants	158 participants	321 participants
		66.3 (63.7 to 69.0)	66.3 (63.0 to 68.3)	66.3 (63.7 to 68.7)
APACHE II Score ^[1] Median (Inter-Quartile Range) Unit of measure: Points
	Number Analyzed	163 participants	158 participants	321 participants
		27 (22 to 33)	29 (22 to 34)	28 (22 to 33)
		[1] Measure Description: The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity score and mortality estimation tool developed from a large sample of ICU patients in the United States. The APACHE II score is made of 12 physiological variables and 2 disease-related variables. The APACHE II score ranges from 0 to 71 points, with higher scores correlating to worse outcomes.
Vasopressor Dose Median (Inter-Quartile Range) Unit of measure: Mcg/kg/min
	Number Analyzed	163 participants	158 participants	321 participants
		0.33 (0.23 to 0.56)	0.34 (0.23 to 0.56)	0.34 (0.23 to 0.56)
Cause of Shock Measure Type: Count of Participants Unit of measure: Participants
Sepsis	Number Analyzed	163 participants	158 participants	321 participants
Sepsis		127 77.9%	132 83.5%	259 80.7%
Other, potentially sepsis	Number Analyzed	163 participants	158 participants	321 participants
Other, potentially sepsis		20 12.3%	11 7.0%	31 9.7%
Pancreatitis	Number Analyzed	163 participants	158 participants	321 participants
Pancreatitis		0 0.0%	2 1.3%	2 0.6%
Vasoplegia	Number Analyzed	163 participants	158 participants	321 participants
Vasoplegia		10 6.1%	9 5.7%	19 5.9%
Other	Number Analyzed	163 participants	158 participants	321 participants
Other		6 3.7%	4 2.5%	10 3.1%

Outcome Measures

1.Primary Outcome


Title	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
Description	Response with respect to mean arterial pressure (MAP) at hour 3 after ...
Description	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.
Time Frame	Hour 3

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	LJPC-501 (Angiotensin II)	Placebo (0.9% Sodium Chloride Solution)
Arm/Group Description:	Treatment arm ...	Placebo arm
Arm/Group Description:	Treatment arm LJPC-501: Treatment arm	Placebo arm Placebo: PBO
Overall Number of Participants Analyzed	163	158
Measure Type: Count of Participants Unit of Measure: Participants
	114 69.9%	37 23.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LJPC-501 (Angiotensin II), Placebo (0.9% Sodium Chloride Solution)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Stratified logistic regression model. Adjusted by baseline MAP and APACHE II, vasopressin use and average NED 6 hours prior to randomization.

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	7.95
	Confidence Interval	(2-Sided) 95% 4.76 to 13.3
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Adverse events were collected from study drug initiation through Day 28.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	LJPC-501 (Angiotensin II)		Placebo (0.9% Sodium Chloride Solution)
Arm/Group Description	Treatment arm ...		Placebo arm
Arm/Group Description	Treatment arm LJPC-501: Treatment arm		Placebo arm Placebo: PBO
All-Cause Mortality
	LJPC-501 (Angiotensin II)		Placebo (0.9% Sodium Chloride Solution)
	Affected / at Risk (%)		Affected / at Risk (%)
Total	75/163 (46.01%)		85/158 (53.80%)
Serious Adverse Events Serious Adverse Events
	LJPC-501 (Angiotensin II)		Placebo (0.9% Sodium Chloride Solution)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	99/163 (60.74%)		106/158 (67.09%)
Blood and lymphatic system disorders
Anaemia ¹	1/163 (0.61%)	1	1/158 (0.63%)	1
Coagulopathy ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Thrombocytopenia ¹	1/163 (0.61%)	1	1/158 (0.63%)	1
Cardiac disorders
Acute myocardial infarction ¹	2/163 (1.23%)	2	2/158 (1.27%)	2
Aortic valve incompetence ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Arrhythmia ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Atrial fibrillation ¹	5/163 (3.07%)	5	5/158 (3.16%)	5
Atrioventricular block ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Bradycardia ¹	1/163 (0.61%)	1	2/158 (1.27%)	2
Cardiac arrest ¹	7/163 (4.29%)	10	9/158 (5.70%)	10
Cardiac failure ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Cardiac failure congestive ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Cardio-respiratory arrest ¹	3/163 (1.84%)	3	5/158 (3.16%)	5
Cardiogenic shock ¹	2/163 (1.23%)	2	4/158 (2.53%)	4
Cardiopulmonary failure ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Myocardial infarction ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Pulseless electrical activity ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Right ventricular dysfunction ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Supraventricular tachycardia ¹	1/163 (0.61%)	1	4/158 (2.53%)	4
Tachycardia ¹	2/163 (1.23%)	2	0/158 (0.00%)	0
Ventricular fibrillation ¹	2/163 (1.23%)	2	0/158 (0.00%)	0
Ventricular tachycardia ¹	5/163 (3.07%)	5	3/158 (1.90%)	3
Gastrointestinal disorders
Dysphagia ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Gastrointestinal haemorrhage ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Gastrointestinal mucosal exfoliation ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Haematemesis ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Intestinal ischaemia ¹	1/163 (0.61%)	1	3/158 (1.90%)	3
Intestinal perforation ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Pancreatitis ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Pancreatitis necrotising ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
General disorders
Device dislocation ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Hypothermia ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Medical device complication ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Multi-organ failure ¹	25/163 (15.34%)	25	23/158 (14.56%)	23
Pyrexia ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Hepatobiliary disorders
Acute hepatic failure ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Cholecystitis ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Hepatic failure ¹	1/163 (0.61%)	1	1/158 (0.63%)	1
Hepatic function abnormal ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Hepatic vascular thrombosis ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Hyperbilirubinaemia ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Ischaemic hepatitis ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Liver disorder ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Infections and infestations
Abdominal abscess ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Abdominal infection ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Bacteraemia ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Cardiac valve vegetation ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Clostridium difficile colitis ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Clostridium difficile sepsis ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Enterobacter bacteraemia ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Liver abscess ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Necrotising fasciitis ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Peritonitis ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Pneumonia ¹	2/163 (1.23%)	2	3/158 (1.90%)	3
Postoperative wound infection ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Pulmonary sepsis ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Sepsis ¹	3/163 (1.84%)	3	2/158 (1.27%)	2
Septic shock ¹	18/163 (11.04%)	18	10/158 (6.33%)	10
Tracheobronchitis ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Gastrostomy tube site complication ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Post procedural haemorrhage ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Pulmonary contusion ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Investigations
Alanine aminotransferase increased ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Blood lactic acid increased ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Electrocardiogram QT prolonged ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Electrocardiogram ST segment elevation ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Liver function test abnormal ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Staphylococcus test positive ¹	1/163 (0.61%)	2	0/158 (0.00%)	0
Metabolism and nutrition disorders
Failure to thrive ¹	2/163 (1.23%)	2	1/158 (0.63%)	1
Hyperkalaemia ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Metabolic acidosis ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Musculoskeletal and connective tissue disorders
Muscle necrosis ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Rhabdomyolysis ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Lung adenocarcinoma stage IV ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Lymphoma ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Pancreatic carcinoma metastatic ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Plasma cell leukaemia ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Prostate cancer ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Small cell carcinoma ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Nervous system disorders
Brain hypoxia ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Brain injury ¹	1/163 (0.61%)	1	2/158 (1.27%)	2
Brain oedema ¹	0/163 (0.00%)	0	2/158 (1.27%)	2
Cerebral haemorrhage ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Cerebral infarction ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Cerebral ischaemia ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Depressed level of conciousness ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Encephalopathy ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Haemorrhage intracranial ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Hemiparesis ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Hypoxic-ischaemic encephalopathy ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Ischaemic stroke ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Metabolic encephalopathy ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Subarachnoid haemorrhage ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Toxic leukoencephalopathy ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Psychiatric disorders
Mental status change ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Renal and urinary disorders
Chronic kidney disease ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Renal failure ¹	1/163 (0.61%)	1	1/158 (0.63%)	1
Renal impairment ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Renal tubular necrosis ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Acute respiratory distress syndrome ¹	0/163 (0.00%)	0	2/158 (1.27%)	2
Acute respiratory failure ¹	3/163 (1.84%)	3	5/158 (3.16%)	5
Aspiration ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Bronchomalacia ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Bronchopleural fistula ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Hypoxia ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Interstitial lung disease ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Pharyngeal haemorrhage ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Pleural effusion ¹	1/163 (0.61%)	1	1/158 (0.63%)	1
Pneumonia aspiration ¹	1/163 (0.61%)	1	1/158 (0.63%)	1
Pneumothorax ¹	1/163 (0.61%)	1	3/158 (1.90%)	3
Pulmonary oedema ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Respiratory arrest ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Respiratory distress ¹	0/163 (0.00%)	0	2/158 (1.27%)	2
Respiratory failure ¹	8/163 (4.91%)	8	11/158 (6.96%)	11
Skin and subcutaneous tissue disorders
Skin discolouration ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Skin necrosis ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Vascular disorders
Aortic dissection ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Circulatory collapse ¹	0/163 (0.00%)	0	1/158 (0.63%)	1
Deep vein thrombosis ¹	3/163 (1.84%)	3	0/158 (0.00%)	0
Distributive shock ¹	1/163 (0.61%)	1	4/158 (2.53%)	4
Hypotension ¹	5/163 (3.07%)	5	3/158 (1.90%)	3
Peripheral ischaemia ¹	5/163 (3.07%)	5	3/158 (1.90%)	3
Shock ¹	3/163 (1.84%)	3	3/158 (1.90%)	3
Shock haemorrhagic ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
Vasospasm ¹	1/163 (0.61%)	1	0/158 (0.00%)	0
1 Term from vocabulary, MedDRA (18.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	LJPC-501 (Angiotensin II)		Placebo (0.9% Sodium Chloride Solution)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	110/163 (67.48%)		108/158 (68.35%)
Blood and lymphatic system disorders
Anaemia ¹	11/163 (6.75%)	11	9/158 (5.70%)	9
Thrombocytopenia ¹	15/163 (9.20%)	15	10/158 (6.33%)	10
Cardiac disorders
Atrial fibrillation ¹	17/163 (10.43%)	18	16/158 (10.13%)	18
Bradycardia ¹	6/163 (3.68%)	6	9/158 (5.70%)	9
Metabolism and nutrition disorders
Hypokalaemia ¹	13/163 (7.98%)	14	10/158 (6.33%)	10
Hypophosphataemia ¹	6/163 (3.68%)	6	11/158 (6.96%)	11
Psychiatric disorders
Agitation ¹	6/163 (3.68%)	6	8/158 (5.06%)	8
Delirium ¹	9/163 (5.52%)	9	1/158 (0.63%)	1
Renal and urinary disorders
Acute kidney injury ¹	8/163 (4.91%)	8	10/158 (6.33%)	11
Respiratory, thoracic and mediastinal disorders
Pleural effusion ¹	8/163 (4.91%)	8	8/158 (5.06%)	8
Vascular disorders
Hypertension ¹	9/163 (5.52%)	11	9/158 (5.70%)	9
Hypotension ¹	13/163 (7.98%)	16	7/158 (4.43%)	7
1 Term from vocabulary, MedDRA (18.0)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

All investigators were restricted from publishing individual papers until the study-wide publication was published. After this time, investigator restrictions varied by institution.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	George Tidmarsh, MD, PhD
Organization:	La Jolla Pharmaceutical Company
Phone:	858-207-4264
EMail:	gtidmarsh@ljpc.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bellomo R, Forni LG, Busse LW, McCurdy MT, Ham KR, Boldt DW, Hastbacka J, Khanna AK, Albertson TE, Tumlin J, Storey K, Handisides D, Tidmarsh GF, Chawla LS, Ostermann M. Renin and Survival in Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock. A Clinical Trial. Am J Respir Crit Care Med. 2020 Nov 1;202(9):1253-1261. doi: 10.1164/rccm.201911-2172OC.

Bellomo R, Wunderink RG, Szerlip H, English SW, Busse LW, Deane AM, Khanna AK, McCurdy MT, Ostermann M, Young PJ, Handisides DR, Chawla LS, Tidmarsh GF, Albertson TE. Angiotensin I and angiotensin II concentrations and their ratio in catecholamine-resistant vasodilatory shock. Crit Care. 2020 Feb 6;24(1):43. doi: 10.1186/s13054-020-2733-x.

Senatore F, Jagadeesh G, Rose M, Pillai VC, Hariharan S, Liu Q, McDowell TY, Sapru MK, Southworth MR, Stockbridge N. FDA Approval of Angiotensin II for the Treatment of Hypotension in Adults with Distributive Shock. Am J Cardiovasc Drugs. 2019 Feb;19(1):11-20. doi: 10.1007/s40256-018-0297-9. Erratum In: Am J Cardiovasc Drugs. 2019 Apr;19(2):227.

Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hastbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21.

Schmull S, Wang Z, Gao L, Lv J, Li J, Xue S. Angiotensins and Their Receptors in Cardiac and Vascular Injury. Curr Hypertens Rev. 2016;12(3):170-180. doi: 10.2174/1573402112666160302101545.

Layout table for additonal information

Responsible Party:	La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier:	NCT02338843
Other Study ID Numbers:	LJ501-CRH01
First Submitted:	January 1, 2015
First Posted:	January 14, 2015
Results First Submitted:	November 28, 2017
Results First Posted:	January 17, 2018
Last Update Posted:	March 27, 2018

To Top