Trials / Completed
CompletedNCT02338843
A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension
A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (CRH)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 344 (actual)
- Sponsor
- La Jolla Pharmaceutical Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LJPC-501 | Treatment arm |
| DRUG | Placebo | PBO |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2016-12-01
- Completion
- 2017-02-18
- First posted
- 2015-01-14
- Last updated
- 2018-03-27
- Results posted
- 2018-01-17
Locations
115 sites across 10 countries: United States, Australia, Belgium, Canada, Finland, France, Germany, New Zealand, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT02338843. Inclusion in this directory is not an endorsement.