Trial · NCT02338843
A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension
NCT02338843, Phase 3, Completed, La Jolla Pharmaceutical Company; results first posted 2018-01-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension. Trials, record NCT02338843. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02338843
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension
- NCT number
- NCT02338843
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 344 participants, actual
- Lead sponsor
- La Jolla Pharmaceutical Company
- Conditions
- Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock, Sepsis
- Interventions
- LJPC-501, Placebo
- First posted
- 2015-01-14
- Last updated
- 2018-03-27
- Results first posted
- 2018-01-17
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Hour 3 | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Hour 3 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | LJPC-501 (Angiotensin II) | 114 | Participants | ||
| 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 | Placebo (0.9% Sodium Chloride Solution) | 37 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LJPC-501 (Angiotensin II) | 163 | |
| Overall Study | STARTED | Placebo (0.9% Sodium Chloride Solution) | 158 | |
| Overall Study | COMPLETED | LJPC-501 (Angiotensin II) | 119 | |
| Overall Study | COMPLETED | Placebo (0.9% Sodium Chloride Solution) | 100 | |
| Overall Study | NOT COMPLETED | LJPC-501 (Angiotensin II) | 44 | |
| Overall Study | NOT COMPLETED | Placebo (0.9% Sodium Chloride Solution) | 58 |
Source ClinicalTrials.gov
Adverse events280
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | LJPC-501 (Angiotensin II) | 11 | 163 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo (0.9% Sodium Chloride Solution) | 9 | 158 | 9 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | LJPC-501 (Angiotensin II) | 15 | 163 | 15 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo (0.9% Sodium Chloride Solution) | 10 | 158 | 10 |
| other | Hypokalaemia | Metabolism and nutrition disorders | LJPC-501 (Angiotensin II) | 13 | 163 | 14 |
| other | Hypokalaemia | Metabolism and nutrition disorders | Placebo (0.9% Sodium Chloride Solution) | 10 | 158 | 10 |
| other | Hypophosphataemia | Metabolism and nutrition disorders | LJPC-501 (Angiotensin II) | 6 | 163 | 6 |
| other | Hypophosphataemia | Metabolism and nutrition disorders | Placebo (0.9% Sodium Chloride Solution) | 11 | 158 | 11 |
| other | Agitation | Psychiatric disorders | LJPC-501 (Angiotensin II) | 6 | 163 | 6 |
| other | Agitation | Psychiatric disorders | Placebo (0.9% Sodium Chloride Solution) | 8 | 158 | 8 |
1 to 10 of 280Source ClinicalTrials.gov
See all 280 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LJPC-501 (Angiotensin II) | 75 | 163 |
| Total, all-cause mortality | Placebo (0.9% Sodium Chloride Solution) | 85 | 158 |
| Total, other adverse events | LJPC-501 (Angiotensin II) | 110 | 163 |
| Total, other adverse events | Placebo (0.9% Sodium Chloride Solution) | 108 | 158 |
| Total, serious adverse events | LJPC-501 (Angiotensin II) | 99 | 163 |
| Total, serious adverse events | Placebo (0.9% Sodium Chloride Solution) | 106 | 158 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
LJPC-501 (Angiotensin II) vs 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 | Trial comparisons |
| LJPC-501 (Angiotensin II) vs Placebo (0.9% Sodium Chloride Solution): deaths from any cause | Trial comparisons |
| LJPC-501 (Angiotensin II) vs Placebo (0.9% Sodium Chloride Solution): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02338843
GET https://conductscience.org/api/trials/v1/NCT02338843/events?page=2