A Phase 3 interventional study of LJPC-501 and Placebo in Catecholamine-resistant Hypotension (CRH), Distributive Shock and High Output Shock, sponsored by La Jolla Pharmaceutical Company. Completed at 115 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-27.
Sponsored by La Jolla Pharmaceutical Company · Phase 3, Interventional, and Treatment
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Among 517 studies in Sepsis with a site in United States — 75 open to participants now, 99 under way, 3 of them phase 3. Sepsis · United States.
Among the 517 studies in Sepsis with a site in United States, this one is the 79th largest by enrollment of the 310 interventional ones that give a count, is one of 24 that started in 2015, is one of 35 in phase 3, and was the 217th registered.
2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.
Browse Sepsis studies →75 of the 517 studies in Sepsis with a site in United States are open now. Recruiting first, the newest first:
Deepull Diagnostics S.L. · Sites in United States, France, Germany and 2 more countries
Intermountain Health Care, Inc. · Sites in United States
Ages 18+
Bassett Healthcare · Sites in United States
Ages 18+
Duke University · Sites in United States
Ages 0 days–7 days
Vanderbilt University Medical Center · Sites in United States
Ages 1 days–12 mo
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
517 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 50 · Phase 2 80 · Phase 3 47 · Phase 4 25
First in 1988; this study’s year is marked. 24 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 344 is above the median of 102 across 1,166 interventional studies indexed under Sepsis.
Median enrollment 84 across the 310 interventional studies, 183 across the 204 observational. Of the 361 that completed or were terminated, 117 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
135 of 517 have an industry lead sponsor. The 10 most frequent:
La Jolla Pharmaceutical Company is the lead sponsor of 18 studies on the registry; none are open to participants now.
La Jolla Pharmaceutical Company has 3 studies filed under Sepsis — fewer than ten, so there is no comparison to draw.
36 of the studies in Sepsis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06817408Mayo ClinicDynamics of Organ Damage and Immune Exhaustion During Sepsis | 2026-12 |
| NCT04796285Brigham and Women's HospitalA Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor | 2026-12 |
| NCT01315782The University of Texas Health Science Center, HoustonAlveolar Dead Space as Predictor of Organ Failure in Severe Sepsis | 2026-12 |
| NCT06692400Loma Linda UniversityThe Effects of Endotracheal Suctioning on Pain and Serum Markers | 2026-12 |
| NCT03133208University of FloridaSepsis Associated Encephalopathy (SAE) Biomarkers | 2026-12-15 |
Add all 36 to your calendar (.ics) → With an account.
Among the 517 studies in Sepsis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment arm
Drug: LJPC-501
Placebo arm
Drug: Placebo
Treatment arm
Also known as: angiotensin II
PBO
Also known as: 0.9% Sodium Chloride Solution USP
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.
Time frame: Hour 3
| Milestone | LJPC-501 (Angiotensin II) | Placebo (0.9% Sodium Chloride Solution) |
|---|---|---|
| Started | 163 | 158 |
| Completed | 119 | 100 |
| Not completed | 44 | 58 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Death | 40 | 53 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Subject recovered | 0 | 2 |
| Withdrew: Discontinued prior to randomizat | 1 | 0 |
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.
| Participants | LJPC-501 (Angiotensin II) | Placebo (0.9% Sodium Chloride Solution) |
|---|---|---|
| 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 | 37 |
Collected over Adverse events were collected from study drug initiation through Day 28.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LJPC-501 (Angiotensin II) | 75/163 (46%) | 99/163 (60.7%) | 110/163 (67.5%) |
| Placebo (0.9% Sodium Chloride Solution) | 85/158 (53.8%) | 106/158 (67.1%) | 108/158 (68.4%) |
| Event | LJPC-501 (Angiotensin II) | Placebo (0.9% Sodium Chloride Solution) |
|---|---|---|
| Multi-organ failureGeneral disorders | 25/163 | 23/158 |
| Septic shockInfections and infestations | 18/163 | 10/158 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 8/163 | 11/158 |
| Cardiac arrestCardiac disorders | 7/163 | 9/158 |
| Atrial fibrillationCardiac disorders | 5/163 | 5/158 |
| Cardio-respiratory arrestCardiac disorders | 3/163 | 5/158 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 3/163 | 5/158 |
| Ventricular tachycardiaCardiac disorders | 5/163 | 3/158 |
| HypotensionVascular disorders | 5/163 | 3/158 |
| Peripheral ischaemiaVascular disorders | 5/163 | 3/158 |
| Event | LJPC-501 (Angiotensin II) | Placebo (0.9% Sodium Chloride Solution) |
|---|---|---|
| Atrial fibrillationCardiac disorders | 17/163 | 16/158 |
| ThrombocytopeniaBlood and lymphatic system disorders | 15/163 | 10/158 |
| HypokalaemiaMetabolism and nutrition disorders | 13/163 | 10/158 |
| HypotensionVascular disorders | 13/163 | 7/158 |
| HypophosphataemiaMetabolism and nutrition disorders | 6/163 | 11/158 |
| AnaemiaBlood and lymphatic system disorders | 11/163 | 9/158 |
| Acute kidney injuryRenal and urinary disorders | 8/163 | 10/158 |
| BradycardiaCardiac disorders | 6/163 | 9/158 |
| HypertensionVascular disorders | 9/163 | 9/158 |
| DeliriumPsychiatric disorders | 9/163 | 1/158 |
| Age, Continuous(years) | LJPC-501 (Angiotensin II) | Placebo (0.9% Sodium Chloride Solution) | Total |
|---|---|---|---|
| Median | 63 (52 to 75) | 65 (53 to 75) | 64 (52 to 75) |
| Sex: Female, Male(Participants) | LJPC-501 (Angiotensin II) | Placebo (0.9% Sodium Chloride Solution) | Total |
|---|---|---|---|
| Female | 71 | 55 | 126 |
| Male | 92 | 103 | 195 |
| Region of Enrollment(Participants) | LJPC-501 (Angiotensin II) | Placebo (0.9% Sodium Chloride Solution) | Total |
|---|---|---|---|
| New Zealand | 4 | 5 | 9 |
| Canada | 26 | 10 | 36 |
| Belgium | 0 | 1 | 1 |
| United States | 90 | 110 | 200 |
| Finland | 5 | 2 | 7 |
| United Kingdom | 9 | 9 | 18 |
| Australia | 24 | 19 | 43 |
| France | 5 | 1 | 6 |
| Germany | 0 | 1 | 1 |
| Body Mass Index (BMI)(Participants) | LJPC-501 (Angiotensin II) | Placebo (0.9% Sodium Chloride Solution) | Total |
|---|---|---|---|
| BMI ≥ 30 | 69 | 71 | 140 |
| BMI < 30 | 92 | 84 | 176 |
| Mean Arterial Pressure (MAP)(mmHg) | LJPC-501 (Angiotensin II) | Placebo (0.9% Sodium Chloride Solution) | Total |
|---|---|---|---|
| Median | 66.3 (63.7 to 69.0) | 66.3 (63.0 to 68.3) | 66.3 (63.7 to 68.7) |
| APACHE II Score(points) | LJPC-501 (Angiotensin II) | Placebo (0.9% Sodium Chloride Solution) | Total |
|---|---|---|---|
| Median | 27 (22 to 33) | 29 (22 to 34) | 28 (22 to 33) |
| Vasopressor Dose(mcg/kg/min) | LJPC-501 (Angiotensin II) | Placebo (0.9% Sodium Chloride Solution) | Total |
|---|---|---|---|
| Median | 0.33 (0.23 to 0.56) | 0.34 (0.23 to 0.56) | 0.34 (0.23 to 0.56) |
| Cause of Shock(Participants) | LJPC-501 (Angiotensin II) | Placebo (0.9% Sodium Chloride Solution) | Total |
|---|---|---|---|
| Sepsis | 127 | 132 | 259 |
| Other, potentially sepsis | 20 | 11 | 31 |
| Pancreatitis | 0 | 2 | 2 |
| Vasoplegia | 10 | 9 | 19 |
| Other | 6 | 4 | 10 |
Showing the first 100 of 115 sites across 10 countries. Choose a country and city above to see the rest.
The record gives a start of Mar 2015, a primary completion of Dec 2016 and a completion of Feb 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2018, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Angiotensin II
La Jolla Pharmaceutical Company