Completed

Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)

Clinicaltrials.gov Identifier: 

nct02476006

Trial details

Trial date:
June 23, 2015 - April 12, 2019
Phase:  3
Birth sex
Male and female gender symbols.
Age range
18 Years and Older
Accepts healthy volunteers
No
Condition(s) being studied: 

Hypercholesterolemia

What is the type of trial? 

Interventional

What is the trial testing? 

ALIROCUMAB SAR236553 (REGN727), atorvastatin, ezetimibe, placebo (for injection training only), rosuvastatin, simvastatin

How many people are being enrolled? 

998

Trial summary

Primary Objective:

To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to alirocumab ahead of commercial availability and to document the overall safety and tolerability of alirocumab in this participant population.

Secondary Objectives:

To document the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels as well as non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (total-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels after 12 weeks of treatment.

To document participant's acceptability of self-injection (Self Injection Assessment Questionnaire, SIAQ).

Trial locations

location(s)