A Phase 2 interventional study of LJPC-501 (angiotensin II) and Placebo in Catecholamine-resistant Hypotension (CRH), Distributive Shock and High Output Shock, sponsored by La Jolla Pharmaceutical Company. Status unknown at 2 sites in 2 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-08-09.
Sponsored by La Jolla Pharmaceutical Company · Phase 2, Interventional, and Treatment
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Among 12 studies testing Angiotensin II in Shock, Septic — 4 open to participants now, 5 under way, none of them phase 3. Angiotensin II · Shock, Septic.
Among the 12 studies testing Angiotensin II in Shock, Septic, this one has the largest planned enrollment, is the only one that started in 2018, is one of 2 in phase 2, and was the 4th registered.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
Browse Shock, Septic studies →4 of the 12 studies testing Angiotensin II in Shock, Septic are open now, in 2 countries. Recruiting first, the newest first:
Brett A Faine · Sites in United States
Ages 18–99
King's College Hospital NHS Trust · Sites in United Kingdom
Ages 18+
Kingman Regional Medical Center · Sites in United States
Ages 18+
Wake Forest University Health Sciences · Sites in United States
Ages 18+
By country, each count listing its studies:
Angiotensin II: first FDA approval 2017 (GIAPREZA), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
Of the 136 Shock, Septic studies recruiting now, 102 (75%) set no upper age limit and 19 (14%) stop at 75 or younger; 12 take children under 18; 13 take healthy volunteers.
This study: 2 Years to 17 Years · 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.
12 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.
Median enrollment 30 across the 12 interventional studies. Of the 3 that completed or were terminated, 3 (100%) have results posted.
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1 of 12 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 1 study filed under Shock, Septic — fewer than ten, so there is no comparison to draw.
1 of the studies testing Angiotensin II in Shock, Septic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06693726Brett A FaineEarly Angiotensin II in the Emergency Department | 2026-12-31 |
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Among the 12 studies testing Angiotensin II in Shock, Septic, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) as assessed by standard of care vasopressor dose reduction in pediatric patients with catecholamine-resistant hypotension (CRH). In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, evaluate changes in catecholamine and other vasopressor doses over time, evaluate the change in MAP over time, and the change in Pediatric Logistic Organ Dysfunction-2 (PELOD-2) scores.
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.
Male and female paediatric patients with catecholamine-resistant hypotension associated with distributive shock.
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.
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).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LJPC-501 Angiotensin II Solution for infusion
Drug: LJPC-501 (angiotensin II)
0.9% sodium chloride solution
Drug: Placebo
Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption.
Placebo Arm
Also known as: 0.9% sodium chloride solution
Proportion of patients who have a >/= 50% reduction in norepinephrine equivalent doses (NED)
Time frame: Hour 3
Effect on Paediatric Logistic Organ Dysfunction-2 (PELOD-2) based on treatment with LJPC-501
Change in PELOD-2 score from baseline to 24 hours and 48 hours after start of LJPC-501. The PELOD-2 score is the sum of 5 individual item scores that totals 0-31 points. A higher PELOD-2 score represents a worse outcome.
Time frame: Baseline, Hour 24 and Hour 48
Effect on total catecholamine doses administered based on treatment with LJPC-501
Change in total catecholamine doses administered from baseline to 24 hours and 48 hours after start of LJPC-501.
Time frame: Baseline, Hour 24 and Hour 48
Effect on mean arterial pressure (MAP) based on treatment with LJPC-501
Change in MAP from baseline to 3 hours, 24 hours and 48 hours after start of LJPC-501
Time frame: Baseline, Hour 3, Hour 24, and Hour 48
Effect on heart rate based on treatment with LJPC-501
Change in heart rate from baseline to 3 hours, 24 hours and 48 hours after start of LJPC-501
Time frame: Baseline to Hour 3, Hour 24, and Hour 48
Assessment of safety based on number of patients with treatment emergent adverse events based on treatment with LJPC-501
Time frame: Day 7
Assessment of tolerability based on the effect on clinical chemistry parameters based on treatment with LJPC-501
Safety data for clinical chemistry parameters including ALT, AST, ALP, total bilirubin, direct bilirubin, creatinine, BUN, lactate, phosphorous, glucose, albumin, calcium, bicarbonate, chloride, sodium, potassium, magnesium
Time frame: Hour 24 and Hour 48
Start is estimated for Aug 2018; primary completion for Mar 2023, 55 months later.
Of 41 phase 2 interventional studies under Shock, Septic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's planned 55 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 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