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Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia

NCT ID: NCT02715726

Last Updated: 2019-09-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

615 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-27

Study Completion Date

2018-08-06

Brief Summary

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Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison to ezetimibe 10 mg daily after 24 weeks of treatment in Asia in participants with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

* To evaluate the effect of alirocumab 75 mg in comparison with ezetimibe 10 mg on LDL-C after 12 weeks of treatment.
* To evaluate the effect of alirocumab on other lipid parameters: e.g., apolipoprotein B (Apo B), non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein a (Lp\[a\]), HDL-C, triglycerides (TG), apolipoprotein A-1 (Apo A-1).
* To evaluate the safety and tolerability of alirocumab.
* To evaluate the development of anti-alirocumab antibodies.
* To evaluate the pharmacokinetics (PK) of alirocumab.

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Detailed Description

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The maximum study duration was 35 weeks per participant, which included a screening period of up to 3 weeks, a 24-week randomized treatment period, and an 8-week post-treatment follow-up period.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ezetimibe 10 mg

Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab every 2 weeks (Q2W) for 22 weeks added to lipid modifying therapy (LMT).

Group Type ACTIVE_COMPARATOR

Placebo for alirocumab

Intervention Type DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

ezetimibe

Intervention Type DRUG

Pharmaceutical form:capsule Route of administration: oral

atorvastatin

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

rosuvastatin

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

simvastatin

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

Alirocumab 75 mg Q2W/up to 150 mg Q2W

Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was \>=70 milligrams per deciliter (mg/dL) (1.81 millimoles per liter \[mmol/L\]) at Week 8.

Group Type EXPERIMENTAL

Alirocumab

Intervention Type DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

placebo for ezetimibe

Intervention Type DRUG

Pharmaceutical form:capsule Route of administration: oral

atorvastatin

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

rosuvastatin

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

simvastatin

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

Interventions

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Alirocumab

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type DRUG

Placebo for alirocumab

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type DRUG

ezetimibe

Pharmaceutical form:capsule Route of administration: oral

Intervention Type DRUG

placebo for ezetimibe

Pharmaceutical form:capsule Route of administration: oral

Intervention Type DRUG

atorvastatin

Pharmaceutical form:tablet Route of administration: oral

Intervention Type DRUG

rosuvastatin

Pharmaceutical form:tablet Route of administration: oral

Intervention Type DRUG

simvastatin

Pharmaceutical form:tablet Route of administration: oral

Intervention Type DRUG

Other Intervention Names

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SAR236553 (REGN727)

Eligibility Criteria

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Inclusion Criteria

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at a stable dose for at least 4 weeks prior to the screening visit (Week -3).

Exclusion Criteria

* Participants without established CHD or CHD risk equivalents.
* LDL-C \<70 mg/dL (\<1.81 mmol/L) at the screening visit (Week -3) in participants with history of documented CV disease.
* LDL-C \<100 mg/dL (\<2.59 mmol/L) at the screening visit (Week -3) in participants without history of documented CV disease.
* Change in statin dose or dose regimen from screening to randomization.
* Currently taking a statin other than atorvastatin, rosuvastatin, or simvastatin.
* Atorvastatin, rosuvastatin, or simvastatin was not taken daily or not taken at a registered dose.
* Daily doses above atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg.
* Use of cholesterol absorption inhibitor (ie, ezetimibe), omega-3 fatty acid (at doses ≥1000 mg daily), nicotinic acid, fibrates, bile acid-binding sequestrant, or red yeast rice products in the past 4 weeks prior to screening visit (Week -3).
* Fasting serum triglycerides \>400 mg/dL (\>4.52 mmol/L) at the screening period.

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 1560027

Beijing, , China

Site Status

Investigational Site Number 1560043

Beijing, , China

Site Status

Investigational Site Number 1560039

Beijing, , China

Site Status

Investigational Site Number 1560012

Beijing, , China

Site Status

Investigational Site Number 1560018

Beijing, , China

Site Status

Investigational Site Number 1560006

Changchun, , China

Site Status

Investigational Site Number 1560020

Changchun, , China

Site Status

Investigational Site Number 1560023

Changsha, , China

Site Status

Investigational Site Number 1560030

Fuzhou, , China

Site Status

Investigational Site Number 1560005

Guangzhou, , China

Site Status

Investigational Site Number 1560040

Guangzhou, , China

Site Status

Investigational Site Number 1560025

Guangzhou, , China

Site Status

Investigational Site Number 1560048

Hangzhou, , China

Site Status

Investigational Site Number 1560037

Hangzhou, , China

Site Status

Investigational Site Number 1560008

Hangzhou, , China

Site Status

Investigational Site Number 1560014

Hohhot, , China

Site Status

Investigational Site Number 1560016

Jinan, , China

Site Status

Investigational Site Number 1560044

Lanzhou, , China

Site Status

Investigational Site Number 1560028

Nanchang, , China

Site Status

Investigational Site Number 1560045

Nanjing, , China

Site Status

Investigational Site Number 1560017

Nanjing, , China

Site Status

Investigational Site Number 1560031

Nanjing, , China

Site Status

Investigational Site Number 1560035

Nanning, , China

Site Status

Investigational Site Number 1560029

Shanghai, , China

Site Status

Investigational Site Number 1560041

Shanghai, , China

Site Status

Investigational Site Number 1560053

Shanghai, , China

Site Status

Investigational Site Number 1560009

Shenyang, , China

Site Status

Investigational Site Number 1560001

Shenyang, , China

Site Status

Investigational Site Number 1560042

Shenyang, , China

Site Status

Investigational Site Number 1560036

Shenzhen, , China

Site Status

Investigational Site Number 1560056

Siping, , China

Site Status

Investigational Site Number 1560021

Taiyuan, , China

Site Status

Investigational Site Number 1560002

Tianjin, , China

Site Status

Investigational Site Number 1560022

Tianjin, , China

Site Status

Investigational Site Number 1560052

Tianjin, , China

Site Status

Investigational Site Number 1560055

Wenzhou, , China

Site Status

Investigational Site Number 1560003

Wuhan, , China

Site Status

Investigational Site Number 1560004

Xi'an, , China

Site Status

Investigational Site Number 1560019

Xuzhou, , China

Site Status

Investigational Site Number 1560054

Yinchuan, , China

Site Status

Investigational Site Number 1560057

Zhanjiang, , China

Site Status

Investigational Site Number 3560017

Belagavi, , India

Site Status

Investigational Site Number 3560001

Gurgaon, , India

Site Status

Investigational Site Number 3560003

Hubli, , India

Site Status

Investigational Site Number 3560010

Kolkata, , India

Site Status

Investigational Site Number 3560019

Kolkata, , India

Site Status

Investigational Site Number 3560020

Mangalore, , India

Site Status

Investigational Site Number 3560006

Mumbai, , India

Site Status

Investigational Site Number 3560007

Nagpur, , India

Site Status

Investigational Site Number 3560004

Nagpur, , India

Site Status

Investigational Site Number 3560008

Nagpur, , India

Site Status

Investigational Site Number 3560016

Nagpur, , India

Site Status

Investigational Site Number 3560014

New Delhi, , India

Site Status

Investigational Site Number 3560005

Pune, , India

Site Status

Investigational Site Number 3560011

Pune, , India

Site Status

Investigational Site Number 3560013

Surat, , India

Site Status

Investigational Site Number 3560015

Vijayawada, , India

Site Status

Investigational Site Number 3560012

Vijaywada, , India

Site Status

Investigational Site Number 7640004

Bangkok, , Thailand

Site Status

Investigational Site Number 7640003

Bangkok Noi, , Thailand

Site Status

Investigational Site Number 7640001

Muang, , Thailand

Site Status

Investigational Site Number 7640002

Pratumwan, , Thailand

Site Status

Countries

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China India Thailand

References

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Han Y, Chen J, Chopra VK, Zhang S, Su G, Ma C, Huang Z, Ma Y, Yao Z, Yuan Z, Zhao Q, Kuanprasert S, Baccara-Dinet MT, Manvelian G, Li J, Chen R. ODYSSEY EAST: Alirocumab efficacy and safety vs ezetimibe in high cardiovascular risk patients with hypercholesterolemia and on maximally tolerated statin in China, India, and Thailand. J Clin Lipidol. 2020 Jan-Feb;14(1):98-108.e8. doi: 10.1016/j.jacl.2019.10.015. Epub 2019 Nov 18.

Reference Type DERIVED
PMID: 31882376 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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U1111-1150-8859

Identifier Type: OTHER

Identifier Source: secondary_id

EFC13889

Identifier Type: -

Identifier Source: org_study_id

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