A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (ATHOS-3)
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|ClinicalTrials.gov Identifier: NCT02338843|
Recruitment Status : Completed
First Posted : January 14, 2015
Results First Posted : January 17, 2018
Last Update Posted : March 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Catecholamine-resistant Hypotension (CRH) Distributive Shock High Output Shock Sepsis||Drug: LJPC-501 Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||344 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (CRH)|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||December 1, 2016|
|Actual Study Completion Date :||February 18, 2017|
Experimental: LJPC-501 (angiotensin II)
Other Name: angiotensin II
Placebo Comparator: Placebo (0.9% sodium chloride solution)
Other Name: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338843
|Study Director:||George F Tidmarsh, MD, PhD||La Jolla Pharmaceutical Company|