Trial Profile
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 12 Jan 2022
Price :
$35
*
At a glance
- Drugs Alirocumab (Primary) ; HMG-CoA reductase inhibitors
- Indications Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Acronyms ODYSSEY-CHOICE-I
- Sponsors Regeneron Pharmaceuticals
- 05 Jun 2019 Results evaluating efficacy and safety of Alirocumab published in the Journal of Clinical Endocrinology and Metabolism
- 25 Apr 2017 According to a Regeneron and Sanofi media release, based on the data from this trial, U.S. FDA approved supplemental Biologics License Application for a once-monthly (every four weeks), 300 mg dose of Praluent (alirocumab) Injection for the treatment of adults with high low-density lipoprotein (LDL) cholesterol. European Commission (EC) also approved the monthly 300 mg dose of Praluent in November 2016.
- 16 Nov 2016 Results (n=299) of a pharmacodynamic analysis presented at the 89th Annual Scientific Sessions of the American Heart Association.