NCT02476006

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

A Multi-country, Multicenter, Single-arm, Open-label Study to Document the Safety, Tolerability and Effect of Alirocumab on Atherogenic Lipoproteins in High Cardio-vascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 998 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study duration included a screening period of up to 3 weeks, a treatment period of a minimum of 12 weeks and up to a maximum of 120 weeks (30 months), and at least 2 weeks after the last study treatment injection.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ALIROCUMAB SAR236553 (REGN727)	Pharmaceutical form:solution Route of administration: subcutaneous
DRUG	placebo (for injection training only)	Pharmaceutical form:solution Route of administration: subcutaneous
DRUG	ezetimibe	Pharmaceutical form:capsule Route of administration: oral
DRUG	atorvastatin	Pharmaceutical form:tablet Route of administration: oral
DRUG	rosuvastatin	Pharmaceutical form:tablet Route of administration: oral
DRUG	simvastatin	Pharmaceutical form:tablet Route of administration: oral

Timeline

• Start date: 2015-06-23
• Primary completion: 2019-04-12
• Completion: 2019-04-12
• First posted: 2015-06-19
• Last updated: 2022-03-28
• Results posted: 2020-03-30

Locations

153 sites across 16 countries: Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland

Regulatory

• FDA-regulated drug study