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) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 27 Jun 2018
At a glance
- Drugs Inclisiran (Primary)
- Indications Atherosclerosis; Cardiovascular disorders; Cerebrovascular disorders; Coronary disorders; Hypercholesterolaemia; Peripheral arterial disorders
- Focus Registrational; Therapeutic Use
- Acronyms ORION-10
- Sponsors The Medicines Company
- 27 Jun 2018 According to The Medicines Company media release, the Independent Data Monitoring Committee (IDMC) under a planned review of the ongoing inclisiran Phase III trials- ORION-9, ORION-10 and ORION-11, has recommended that the trials continue as designed and conducted, without modification. The IDMC's recommendation was based on its review of unblinded safety and efficacy data from the trials.
- 08 Mar 2018 According to The Medicines Company media release, more than 1,500 patients randomized in this trial. Data read-out expected in Q3/2019
- 08 Mar 2018 Status changed from recruiting to active, no longer recruiting, as reported in The Medicines Company media release.