Trial Profile
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients with Primary Hypercholesterolemia Not Treated With a Statin
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 07 Nov 2021
Price :
$35
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At a glance
- Drugs Alirocumab (Primary)
- Indications Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Acronyms ODYSSEY-CHOICE-II
- Sponsors Sanofi
- 07 Aug 2017 Status changed from active, no longer recruiting to completed.
- 24 Jul 2015 The EMA's CHMP adopted a positive opinion for the marketing authorization of Praluent (alirocumab), recommending its approval for use in certain adult patients with hypercholesterolemia, according to a Sanofi and Regeneron Pharmaceuticals media release.
- 17 Jul 2015 Planned End Date changed from 1 May 2016 to 1 Jun 2017, according to ClinicalTrials.gov record.