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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Alirocumab

Placebo for alirocumab

ezetimibe

placebo for ezetimibe

atorvastatin

rosuvastatin

simvastatin

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ezetimibe 10 mg

Alirocumab 75 mg Q2W/up to 150 mg Q2W

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis

Adjusted least square (LS) means and standard errors at Week 24 were obtained from mixed models analysis with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).

Secondary Outcome Measures

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: ITT Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: On-Treatment Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).

Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Apolipoprotein B at Week 24: On-Treatment Analysis

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24: ITT Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24: ITT Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 up to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 12: ITT Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Total Cholesterol at Week 12: ITT Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: ITT Analysis

Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model.

Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: On-Treatment Analysis

Adjusted percentages at Week 24 were obtained from multiple imputation approach including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).

Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 24: ITT Analysis

Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model.

Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 24: ITT Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Fasting Triglycerides (TG) at Week 24: ITT Analysis

Adjusted means and standard errors at Week 24 were obtained by using multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24: ITT Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Analysis

Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12: ITT Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Fasting Triglycerides at Week 12: ITT Analysis

Adjusted means and standard errors at Week 12 were obtained by using multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Apolipoprotein A-1 at Week 12 : ITT Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Full Information

NCT ID

NCT02715726

First Posted

March 16, 2016

Last Updated

September 9, 2019

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02715726

Brief Title

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

Acronym

ODYSSEY EAST

Official Title

A Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

July 27, 2016 (Actual)

Primary Completion Date

August 6, 2018 (Actual)

Study Completion Date

August 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

615 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ezetimibe 10 mg

Arm Type

Active Comparator

Arm Description

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).

Arm Title

Alirocumab 75 mg Q2W/up to 150 mg Q2W

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Alirocumab

Other Intervention Name(s)

SAR236553 (REGN727)

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

Placebo for alirocumab

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

ezetimibe

Intervention Description

Pharmaceutical form:capsule Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

placebo for ezetimibe

Intervention Description

Pharmaceutical form:capsule Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

atorvastatin

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

rosuvastatin

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

simvastatin

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis

Description

Time Frame

From Baseline to Week 24

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 12

Title

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: On-Treatment Analysis

Description

Time Frame

From Baseline to Week 12

Title

Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Apolipoprotein B at Week 24: On-Treatment Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24: ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24: ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 up to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 12

Title

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 12: ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 12

Title

Percent Change From Baseline in Total Cholesterol at Week 12: ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 12

Title

Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: ITT Analysis

Description

Time Frame

Up to Week 24

Title

Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: On-Treatment Analysis

Description

Time Frame

Up to Week 24

Title

Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 24: ITT Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 24: ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Fasting Triglycerides (TG) at Week 24: ITT Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24: ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Analysis

Description

Time Frame

From Baseline to Week 12

Title

Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12: ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 12

Title

Percent Change From Baseline in Fasting Triglycerides at Week 12: ITT Analysis

Description

Time Frame

From Baseline to Week 12

Title

Percent Change From Baseline in Apolipoprotein A-1 at Week 12 : ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 1560027

City

Beijing

ZIP/Postal Code

100029

Country

China

Facility Name

Investigational Site Number 1560043

City

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Investigational Site Number 1560039

City

Beijing

ZIP/Postal Code

100053

Country

China

Facility Name

Investigational Site Number 1560012

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Investigational Site Number 1560018

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Investigational Site Number 1560006

City

Changchun

ZIP/Postal Code

130021

Country

China

Facility Name

Investigational Site Number 1560020

City

Changchun

ZIP/Postal Code

130021

Country

China

Facility Name

Investigational Site Number 1560023

City

Changsha

ZIP/Postal Code

410011

Country

China

Facility Name

Investigational Site Number 1560030

City

Fuzhou

ZIP/Postal Code

354200

Country

China

Facility Name

Investigational Site Number 1560005

City

Guangzhou

ZIP/Postal Code

510080

Country

China

Facility Name

Investigational Site Number 1560040

City

Guangzhou

ZIP/Postal Code

510080

Country

China

Facility Name

Investigational Site Number 1560025

City

Guangzhou

ZIP/Postal Code

510120

Country

China

Facility Name

Investigational Site Number 1560048

City

Hangzhou

ZIP/Postal Code

310014

Country

China

Facility Name

Investigational Site Number 1560037

City

Hangzhou

ZIP/Postal Code

310015

Country

China

Facility Name

Investigational Site Number 1560008

City

Hangzhou

ZIP/Postal Code

310016

Country

China

Facility Name

Investigational Site Number 1560014

City

Hohhot

ZIP/Postal Code

010017

Country

China

Facility Name

Investigational Site Number 1560016

City

Jinan

ZIP/Postal Code

250013

Country

China

Facility Name

Investigational Site Number 1560044

City

Lanzhou

ZIP/Postal Code

730000

Country

China

Facility Name

Investigational Site Number 1560028

City

Nanchang

ZIP/Postal Code

330006

Country

China

Facility Name

Investigational Site Number 1560045

City

Nanjing

ZIP/Postal Code

210006

Country

China

Facility Name

Investigational Site Number 1560017

City

Nanjing

ZIP/Postal Code

210008

Country

China

Facility Name

Investigational Site Number 1560031

City

Nanjing

ZIP/Postal Code

210011

Country

China

Facility Name

Investigational Site Number 1560035

City

Nanning

ZIP/Postal Code

530031

Country

China

Facility Name

Investigational Site Number 1560029

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Investigational Site Number 1560041

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Investigational Site Number 1560053

City

Shanghai

ZIP/Postal Code

201199

Country

China

Facility Name

Investigational Site Number 1560009

City

Shenyang

ZIP/Postal Code

110004

Country

China

Facility Name

Investigational Site Number 1560001

City

Shenyang

ZIP/Postal Code

110016

Country

China

Facility Name

Investigational Site Number 1560042

City

Shenyang

ZIP/Postal Code

110016

Country

China

Facility Name

Investigational Site Number 1560036

City

Shenzhen

ZIP/Postal Code

518036

Country

China

Facility Name

Investigational Site Number 1560056

City

Siping

ZIP/Postal Code

136000

Country

China

Facility Name

Investigational Site Number 1560021

City

Taiyuan

ZIP/Postal Code

030001

Country

China

Facility Name

Investigational Site Number 1560002

City

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

Investigational Site Number 1560022

City

Tianjin

ZIP/Postal Code

300121

Country

China

Facility Name

Investigational Site Number 1560052

City

Tianjin

ZIP/Postal Code

300140

Country

China

Facility Name

Investigational Site Number 1560055

City

Wenzhou

ZIP/Postal Code

325000

Country

China

Facility Name

Investigational Site Number 1560003

City

Wuhan

ZIP/Postal Code

430022

Country

China

Facility Name

Investigational Site Number 1560004

City

Xi'An

ZIP/Postal Code

710061

Country

China

Facility Name

Investigational Site Number 1560019

City

Xuzhou

ZIP/Postal Code

221002

Country

China

Facility Name

Investigational Site Number 1560054

City

Yinchuan

ZIP/Postal Code

750004

Country

China

Facility Name

Investigational Site Number 1560057

City

Zhanjiang

ZIP/Postal Code

524001

Country

China

Facility Name

Investigational Site Number 3560017

City

Belgaum

ZIP/Postal Code

590010

Country

India

Facility Name

Investigational Site Number 3560001

City

Gurgaon

ZIP/Postal Code

122001

Country

India

Facility Name

Investigational Site Number 3560003

City

Hubli

ZIP/Postal Code

580021

Country

India

Facility Name

Investigational Site Number 3560010

City

Kolkata

ZIP/Postal Code

700020

Country

India

Facility Name

Investigational Site Number 3560019

City

Kolkata

ZIP/Postal Code

700073

Country

India

Facility Name

Investigational Site Number 3560020

City

Mangalore

ZIP/Postal Code

575002

Country

India

Facility Name

Investigational Site Number 3560006

City

Mumbai

Country

India

Facility Name

Investigational Site Number 3560007

City

Nagpur

ZIP/Postal Code

440003

Country

India

Facility Name

Investigational Site Number 3560004

City

Nagpur

ZIP/Postal Code

440010

Country

India

Facility Name

Investigational Site Number 3560008

City

Nagpur

ZIP/Postal Code

440012

Country

India

Facility Name

Investigational Site Number 3560016

City

Nagpur

ZIP/Postal Code

440012

Country

India

Facility Name

Investigational Site Number 3560014

City

New Delhi

ZIP/Postal Code

110002

Country

India

Facility Name

Investigational Site Number 3560005

City

Pune

ZIP/Postal Code

411001

Country

India

Facility Name

Investigational Site Number 3560011

City

Pune

ZIP/Postal Code

411001

Country

India

Facility Name

Investigational Site Number 3560013

City

Surat

ZIP/Postal Code

395002

Country

India

Facility Name

Investigational Site Number 3560015

City

Vijayawada

ZIP/Postal Code

520008

Country

India

Facility Name

Investigational Site Number 3560012

City

Vijaywada

ZIP/Postal Code

520002

Country

India

Facility Name

Investigational Site Number 7640003

City

Bangkok-Noi

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Investigational Site Number 7640004

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Investigational Site Number 7640001

City

Muang

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Investigational Site Number 7640002

City

Pratumwan

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

31882376

Citation

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.

Results Reference

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

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

Hypercholesterolemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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