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A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (CRH)

Trial Profile

A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (CRH)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Aug 2019

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At a glance

  • Drugs Angiotensin II (Primary)
  • Indications Hypotension
  • Focus Registrational; Therapeutic Use
  • Acronyms ATHOS-3
  • Sponsors La Jolla Pharmaceutical Company
  • Most Recent Events

    • 29 Aug 2019 According to a La Jolla Pharmaceutical Company media release, the ECs decision is applicable to the 28 European Union member countries. Approval will also be recognized in Iceland, Norway and Liechtenstein.
    • 29 Aug 2019 According to a La Jolla Pharmaceutical Company media release, based on data from this phase III study (ATHOS-3), the European Commission(EC) has approved GIAPREZA (angiotensin II) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies.
    • 01 Aug 2019 According to a La Jolla Pharmaceutical Company media release, company expect a final approval decision on the GIAPREZA MAA by the EC in the third quarter of 2019.
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