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

Primary Purpose

Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LJPC-501
Placebo
Sponsored by
La Jolla Pharmaceutical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Catecholamine-resistant Hypotension (CRH)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients ≥ 18 years of age with CRH, defined as those who require a total sum catecholamine dose of > 0.2 mcg/kg/min for a minimum of 6 hours and a maximum of 48 hours, to maintain a MAP between 55-70 mmHg.
  2. Patients are required to have central venous access and an arterial line present, and these are expected to remain present for at least the initial 48 hours of study.
  3. Patients are required to have an indwelling urinary catheter present, and it is expected to remain present for at least the initial 48 hours of study.
  4. Patients must have received at least 25 mL/kg of crystalloid or colloid equivalent over the previous 24-hour period, and be adequately volume resuscitated in the opinion of the treating investigator.

  5. Patients must have clinical features of high-output shock by meeting one of the following criteria.

    1. Central venous oxygen saturation (ScvO2) > 70% (either by oximetry catheter or by central venous blood gas) and central venous pressure (CVP) > 8 mmHg.

      OR

    2. Cardiac Index (CI) > 2.3 L/min/1.73 m2. Patient must meet 5a or 5b to be eligible.
  6. Patient or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements.

Exclusion Criteria:

  1. Patients who are < 18 years of age.
  2. Any patient with burns covering > 20% of total body surface area (TBSA).
  3. Patients with a Cardiovascular (CV) SOFA score ≤ 3.
  4. Patients diagnosed with acute occlusive coronary syndrome requiring intervention.
  5. Patients on veno-arterial (VA) ECMO.
  6. Patients who have been on ECMO for less than 12 hours.
  7. Patients in liver failure with a Model for End-Stage Liver Disease (MELD) score of ≥ 30.
  8. Patients with a history of asthma or who are currently experiencing bronchospasm requiring the use of inhaled bronchodilators, if not mechanically ventilated.
  9. Patients with acute mesenteric ischemia or a history of mesenteric ischemic.
  10. Patients with a history of, presence of, or highly-suspected of having an aortic dissection or abdominal aortic aneurysm.
  11. Patients requiring more than 500 mg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose.
  12. Patients with Raynaud's phenomenon, systemic sclerosis or vasospastic disease.
  13. Patients with an expected lifespan of < 12 hours.
  14. Patients with active bleeding AND an anticipated need (within 48 hours of initiation of the study) for transfusion of > 4 units of packed red blood cells.
  15. Patients with active bleeding AND hemoglobin < 7g/dL or any other condition that would contraindicate serial blood sampling.
  16. Patients with an absolute neutrophil count (ANC) of < 1000 cells/mm3.
  17. Patients with a known allergy to mannitol.
  18. Patients who are current participating in another interventional clinical trial.
  19. Patients who are known to be pregnant at the time of Screening.

Sites / Locations

  • Pulmonary Associates of Mobile, PC
  • Mayo Clinic Arizona
  • Loma Linda University Medical Center
  • Keck Hospital of USC
  • Los Angeles County + University of Southern California Medical Center
  • University of California, Los Angeles
  • University of California, Irvine Medical Center
  • University of California, Davis
  • University of Florida
  • Emory University
  • Joseph M. Still Research Foundation, Inc.
  • Eastern Idaho Regional Medical Center
  • Northwestern University
  • Methodist Hospital, Indiana University Health Physicians
  • Kentucky Lung Clinic
  • University of Louisville
  • University of Maryland Medical Center
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Henry Ford Hospital
  • Hennepin County Medical Center
  • Mayo Clinic
  • St. Paul Regions Hospital
  • Saint Louis University
  • Sunrise Hospital/eStudySite
  • Englewood Hospital & Medical Center
  • Rutgers Robert Wood Johnson Medical Center
  • Montefiore Medical Center, Weiler Division
  • Montefiore Medical Center
  • Duke Regional Hospital
  • Duke University Medical Center
  • Moses Cone Health
  • Wesley Long Hospital
  • University of Cincinnati Medical Center
  • Cleveland Clinic - Fairview Hospital
  • The Cleveland Clinic Foundation
  • Riverside Methodist Hospital
  • University of Oklahoma Medical Center
  • Oregon Health & Sciences University
  • Lehigh Valley Health Network
  • Geisinger Medical Center
  • Penn Presbyterian Medical Center
  • University of Pennsylvania
  • University of Pittsburgh Medical Center
  • Erlanger Hospital
  • Memorial Hospital
  • Baylor University
  • John Peter Smith Hospital - JPS Health Network
  • U.S. Army Military Medical Center
  • Inova Fairfax Hospital
  • Virginia Commonwealth University Medical Center
  • Canberra Hospital
  • John Hunter Hospital
  • Nepean Hospital
  • Royal North Shore Hospital
  • The Wesley Hospital
  • Royal Brisbane & Women's Hospital
  • Gold Coast University Hospital
  • Princess Alexandra Hospital
  • Flinders Medical Centre
  • Royal Hobart Hospital
  • Monash Medical Centre
  • Frankston Hospital
  • Austin Hospital
  • St. Vincent's Hospital
  • Royal Melbourne Hospital
  • Fiona Stanley Hospital
  • Royal Perth Hospital
  • Royal Adelaide Hospital
  • UZ Antwerpen
  • Brugmann University Hospital
  • UZ Brussel
  • Erasme University Hospital
  • UZ Gent
  • South Health Campus & Rockyview General Hospital
  • Royal Alexandra Hospital
  • University of Alberta Hospital
  • St. Paul's Hospital
  • Royal Jubilee Hospital
  • Victoria General Hospital
  • Kingston General Hospital
  • The Ottawa Hospital - Civic Campus
  • The Ottawa Hospital - General Campus
  • St. Michael's Hospital
  • Helsinki University Central Hospital
  • Kuopio University Hospital
  • Tampere University Hospital
  • Turku University Hospital
  • Jean Minjoz Hospital
  • Hospital Roger Salengro, CHRU de Lille
  • CHU Nice
  • Bordeaux Hospital University Center
  • University Medical Center, Berlin
  • University Hospital Münster
  • Auckland City Hospital
  • Middlemore Hospital
  • Wellington Hospital
  • Bern University Hospital
  • Southampton General Hospital
  • Norfolk and Norwich University Hospitals
  • Sunderland Royal Hospital
  • Birmingham Heartlands Hospital
  • Queen Elizabeth Hospital
  • Bristol Royal Infirmary
  • Addenbrooke's Hospital
  • Hull Royal Infirmary
  • Royal London Hospital
  • St. Thomas Hospital
  • St. George's University Hospital
  • Charing Cross Hospital
  • Hammersmith Hospital
  • Royal Liverpool Hospital
  • Northampton General Hospital
  • Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LJPC-501 (angiotensin II)

Placebo (0.9% sodium chloride solution)

Arm Description

Treatment arm

Placebo arm

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
January 1, 2015
Last Updated
February 27, 2018
Sponsor
La Jolla Pharmaceutical Company
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1. Study Identification

Unique Protocol Identification Number
NCT02338843
Brief Title
A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension
Acronym
ATHOS-3
Official Title
A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (CRH)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
February 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
La Jolla Pharmaceutical Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers globally.
Detailed Description
Catecholamine-resistant hypotension (CRH) is an often fatal condition resulting from an underlying cause such as septic shock, inflammation due to trauma, or severe drug reactions. When these conditions occur, most patients will respond to either volume expansion or vasopressor treatment. However, some patients will require excessive doses of vasopressors and will be deemed to be resistant. Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption. LJPC-501 (angiotensin II) is being developed for the treatment of patients with catecholamine-resistant hypotension (CRH). This is a multi-site, randomized, double-blind, placebo-controlled study. Adult patients with CRH, who are hospitalized in an ICU setting, may be eligible to participate. Approximately 315 patients will be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock, Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
344 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LJPC-501 (angiotensin II)
Arm Type
Experimental
Arm Description
Treatment arm
Arm Title
Placebo (0.9% sodium chloride solution)
Arm Type
Placebo Comparator
Arm Description
Placebo arm
Intervention Type
Drug
Intervention Name(s)
LJPC-501
Other Intervention Name(s)
angiotensin II
Intervention Description
Treatment arm
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% Sodium Chloride Solution USP
Intervention Description
PBO
Primary Outcome Measure Information:
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 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients ≥ 18 years of age with CRH, defined as those who require a total sum catecholamine dose of > 0.2 mcg/kg/min for a minimum of 6 hours and a maximum of 48 hours, to maintain a MAP between 55-70 mmHg. Patients are required to have central venous access and an arterial line present, and these are expected to remain present for at least the initial 48 hours of study. Patients are required to have an indwelling urinary catheter present, and it is expected to remain present for at least the initial 48 hours of study. Patients must have received at least 25 mL/kg of crystalloid or colloid equivalent over the previous 24-hour period, and be adequately volume resuscitated in the opinion of the treating investigator. Patients must have clinical features of high-output shock by meeting one of the following criteria. Central venous oxygen saturation (ScvO2) > 70% (either by oximetry catheter or by central venous blood gas) and central venous pressure (CVP) > 8 mmHg. OR Cardiac Index (CI) > 2.3 L/min/1.73 m2. Patient must meet 5a or 5b to be eligible. Patient or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements. Exclusion Criteria: Patients who are < 18 years of age. Any patient with burns covering > 20% of total body surface area (TBSA). Patients with a Cardiovascular (CV) SOFA score ≤ 3. Patients diagnosed with acute occlusive coronary syndrome requiring intervention. Patients on veno-arterial (VA) ECMO. Patients who have been on ECMO for less than 12 hours. Patients in liver failure with a Model for End-Stage Liver Disease (MELD) score of ≥ 30. Patients with a history of asthma or who are currently experiencing bronchospasm requiring the use of inhaled bronchodilators, if not mechanically ventilated. Patients with acute mesenteric ischemia or a history of mesenteric ischemic. Patients with a history of, presence of, or highly-suspected of having an aortic dissection or abdominal aortic aneurysm. Patients requiring more than 500 mg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose. Patients with Raynaud's phenomenon, systemic sclerosis or vasospastic disease. Patients with an expected lifespan of < 12 hours. Patients with active bleeding AND an anticipated need (within 48 hours of initiation of the study) for transfusion of > 4 units of packed red blood cells. Patients with active bleeding AND hemoglobin < 7g/dL or any other condition that would contraindicate serial blood sampling. Patients with an absolute neutrophil count (ANC) of < 1000 cells/mm3. Patients with a known allergy to mannitol. Patients who are current participating in another interventional clinical trial. Patients who are known to be pregnant at the time of Screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George F Tidmarsh, MD, PhD
Organizational Affiliation
La Jolla Pharmaceutical Company
Official's Role
Study Director
Facility Information:
Facility Name
Pulmonary Associates of Mobile, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Los Angeles County + University of Southern California Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Joseph M. Still Research Foundation, Inc.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Eastern Idaho Regional Medical Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Methodist Hospital, Indiana University Health Physicians
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Kentucky Lung Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Paul Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Sunrise Hospital/eStudySite
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Englewood Hospital & Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Rutgers Robert Wood Johnson Medical Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Montefiore Medical Center, Weiler Division
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Duke Regional Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Moses Cone Health
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Wesley Long Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic - Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
University of Oklahoma Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Erlanger Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37408
Country
United States
Facility Name
Memorial Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37408
Country
United States
Facility Name
Baylor University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
John Peter Smith Hospital - JPS Health Network
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
U.S. Army Military Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Nepean Hospital
City
Penrith
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
The Wesley Hospital
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
St. Vincent's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
UZ Antwerpen
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Brugmann University Hospital
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Erasme University Hospital
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
South Health Campus & Rockyview General Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Royal Jubilee Hospital
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Victoria General Hospital
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8Z 6R5
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7I 2V7
Country
Canada
Facility Name
The Ottawa Hospital - Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
KIH 8L6
Country
Canada
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
KIH 8L6
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Jean Minjoz Hospital
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hospital Roger Salengro, CHRU de Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Nice
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Bordeaux Hospital University Center
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
University Medical Center, Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
University Hospital Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Auckland City Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Middlemore Hospital
City
Otahuhu
State/Province
Auckland
Country
New Zealand
Facility Name
Wellington Hospital
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Bern University Hospital
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospitals
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Sunderland Royal Hospital
City
Sunderland
State/Province
Tyne And Wear
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham, West Midlands
ZIP/Postal Code
B15 2WB
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
St. Thomas Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
St. George's University Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Royal Liverpool Hospital
City
Merseyside
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Northampton General Hospital
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32609011
Citation
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.
Results Reference
derived
PubMed Identifier
32028998
Citation
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.
Results Reference
derived
PubMed Identifier
30144016
Citation
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.
Results Reference
derived
PubMed Identifier
28528561
Citation
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.
Results Reference
derived
PubMed Identifier
26931475
Citation
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.
Results Reference
derived

Learn more about this trial

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

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