LJPC-501 in Patients with Catecholamine-Resistant Hypotension
Research type
Research Study
Full title
A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients with Catecholamine-Resistant Hypotension (CRH)
IRAS ID
183877
Contact name
Inge Bear
Contact email
Sponsor organisation
La Jolla Pharmaceutical Company, Inc.
Eudract number
2015-002448-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
In this study we are examining whether an investigational drug called LJPC-501 can improve the treatment of critically ill patients who have a condition called catecholamine resistant hypotension, which is characterised by a very low blood pressure that does not respond to the usual medication and treatments available to doctors in the intensive care unit. Catecholamine resistant hypotension is often fatal and there is a need to develop better treatments for this condition. LJPC-501 is a synthetic form of a naturally occurring hormone that increases blood pressure known as Angiotensin II. To assess effects of LJPC-501 patients in the study will be given either LJPC-501 or a dummy medication (a placebo) while all of their other treatments are continued. The study will examine the effectiveness of LJPC-501 in increasing the mean arterial blood pressure and also closely monitor patients to assess the safety and tolerability of the medication.
REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0464
Date of REC Opinion
7 Mar 2016
REC opinion
Further Information Favourable Opinion