Overview

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Treatments:
Antibodies, Monoclonal
Criteria
Inclusion criteria:

- Participants with heterozygous familial hypercholesterolemia who were not adequately
controlled with their lipid-modifying therapy.

Exclusion criteria:

- Age < 18 years

- LDL-C < 160 mg/dL (< 4.14 mmol/L) at the screening visit (Week-3).

- Fasting serum triglycerides > 400 mg/dL (> 4.52 mmol/L) during the screening period.

- Known history of homozygous familial hypercholesterolemia.

The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.