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

NCT02476006 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 998

Last updated 2022-03-28

Study results available
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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).

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-23
Primary Completion
2019-04-12
Completion
2019-04-12
FDA Drug
Yes

Countries

  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Poland
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02476006 on ClinicalTrials.gov