A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO EVALUATE THE EFFECT OF 300 MG OF INCLISIRAN SODIUM GIVEN AS SUBCUTANEOUS INJECTIONS IN SUBJECTS WITH ATHEROSCLEROTIC CARDIOVASCULAR DISEASE (ASCVD) OR ASCVD-RISK EQUIVALENTS AND ELEVATED LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C)

Trial Profile

A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO EVALUATE THE EFFECT OF 300 MG OF INCLISIRAN SODIUM GIVEN AS SUBCUTANEOUS INJECTIONS IN SUBJECTS WITH ATHEROSCLEROTIC CARDIOVASCULAR DISEASE (ASCVD) OR ASCVD-RISK EQUIVALENTS AND ELEVATED LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2017

At a glance

  • Drugs Inclisiran (Primary)
  • Indications Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ORION-11
  • Sponsors The Medicines Company
  • Most Recent Events

    • 06 Nov 2017 According to The Medicines Company media release, the phase III program for inclisiran comprises four trials ORION-5, ORION-9, ORION-10 and ORION-11. The data from these trials will support the submission of a New Drug Application (NDA) in the United States and a Marketing Authorization Application (MAA) in the European Union at or around the end of 2019.
    • 06 Nov 2017 According to The Medicines Company media release, patient dosing commenced on 1 Nov. Professor Kausik Ray, Professor of Public Health, Imperial College London, United Kingdom, and Honorary Consultant Cardiologist, Imperial College NHS Trust, is the principal investigator of this trial.
    • 06 Nov 2017 Status changed from planning to recruiting, according to The Medicines Company media release.
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