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

PHASE3CompletedINTERVENTIONAL
Enrollment

615

Participants

Timeline

Start Date

July 27, 2016

Primary Completion Date

August 6, 2018

Study Completion Date

August 6, 2018

Conditions
Hypercholesterolemia
Interventions
DRUG

Alirocumab

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

Placebo for alirocumab

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

ezetimibe

Pharmaceutical form:capsule Route of administration: oral

DRUG

placebo for 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

Trial Locations (62)

10400

Investigational Site Number 7640004, Bangkok

Investigational Site Number 7640002, Pratumwan

10700

Investigational Site Number 7640003, Bangkok Noi

50200

Investigational Site Number 7640001, Muang

100029

Investigational Site Number 1560027, Beijing

100034

Investigational Site Number 1560043, Beijing

100053

Investigational Site Number 1560039, Beijing

100730

Investigational Site Number 1560012, Beijing

Investigational Site Number 1560018, Beijing

110002

Investigational Site Number 3560014, New Delhi

110004

Investigational Site Number 1560009, Shenyang

110016

Investigational Site Number 1560001, Shenyang

Investigational Site Number 1560042, Shenyang

122001

Investigational Site Number 3560001, Gūrgaon

130021

Investigational Site Number 1560006, Changchun

Investigational Site Number 1560020, Changchun

136000

Investigational Site Number 1560056, Siping

200025

Investigational Site Number 1560029, Shanghai

200040

Investigational Site Number 1560041, Shanghai

201199

Investigational Site Number 1560053, Shanghai

210006

Investigational Site Number 1560045, Nanjing

210008

Investigational Site Number 1560017, Nanjing

210011

Investigational Site Number 1560031, Nanjing

221002

Investigational Site Number 1560019, Xuzhou

250013

Investigational Site Number 1560016, Jinan

300052

Investigational Site Number 1560002, Tianjin

300121

Investigational Site Number 1560022, Tianjin

300140

Investigational Site Number 1560052, Tianjin

310014

Investigational Site Number 1560048, Hangzhou

310015

Investigational Site Number 1560037, Hangzhou

310016

Investigational Site Number 1560008, Hangzhou

325000

Investigational Site Number 1560055, Wenzhou

330006

Investigational Site Number 1560028, Nanchang

354200

Investigational Site Number 1560030, Fuzhou

395002

Investigational Site Number 3560013, Surat

410011

Investigational Site Number 1560023, Changsha

411001

Investigational Site Number 3560005, Pune

Investigational Site Number 3560011, Pune

430022

Investigational Site Number 1560003, Wuhan

440003

Investigational Site Number 3560007, Nagpur

440010

Investigational Site Number 3560004, Nagpur

440012

Investigational Site Number 3560008, Nagpur

Investigational Site Number 3560016, Nagpur

510080

Investigational Site Number 1560005, Guangzhou

Investigational Site Number 1560040, Guangzhou

510120

Investigational Site Number 1560025, Guangzhou

518036

Investigational Site Number 1560036, Shenzhen

520002

Investigational Site Number 3560012, Vijaywada

520008

Investigational Site Number 3560015, Vijayawada

524001

Investigational Site Number 1560057, Zhanjiang

530031

Investigational Site Number 1560035, Nanning

575002

Investigational Site Number 3560020, Mangalore

580021

Investigational Site Number 3560003, Hubli

590010

Investigational Site Number 3560017, Belagavi

700020

Investigational Site Number 3560010, Kolkata

700073

Investigational Site Number 3560019, Kolkata

710061

Investigational Site Number 1560004, Xi'an

730000

Investigational Site Number 1560044, Lanzhou

750004

Investigational Site Number 1560054, Yinchuan

010017

Investigational Site Number 1560014, Hohhot

030001

Investigational Site Number 1560021, Taiyuan

Unknown

Investigational Site Number 3560006, Mumbai

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY