Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)
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Trial details
How far along a trial is in the process. There are several phases: Phase 1, Phase 2, Phase 3 and Phase 4.
Trials that are looking for healthy people to participate.
The disease(s) being studied in a trial.
Hypercholesterolaemia
An interventional trial typically studies a potential medicine. An observational trial watches a person's health over time with no investigational medicine given.
Interventional
The new medicine being studied.
Alirocumab, Lipid Modifying Therapy (LMT), Placebo (for alirocumab)
The number of people the researchers want in the trial.
107
Trial summary
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
Primary Objective of the study:
To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.
Secondary Objectives:
* To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
* To evaluate the effects of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab
Trial locations
0 location(s)