A Study to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia Not Adequately Controlled on Statin Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

305

Participants

Timeline

Start Date

December 8, 2020

Primary Completion Date

June 15, 2022

Study Completion Date

June 15, 2022

Conditions
Hypercholesterolemia
Interventions
DRUG

Rosuvastatin

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

SPC ezetimibe/rosuvastatin

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

Rosuvastatin active capsule

Pharmaceutical form:Capsule Route of administration: Oral

DRUG

Placebo

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

Placebo

Pharmaceutical form:Capsule Route of administration: Oral

Trial Locations (40)

100029

Investigational Site Number :1560001, Beijing

100050

Investigational Site Number :1560068, Beijing

101200

Investigational Site Number :1560021, Beijing

110016

Investigational Site Number :1560034, Shenyang

116033

Investigational Site Number :1560015, Dalian

130021

Investigational Site Number :1560045, Changchun

130033

Investigational Site Number :1560067, Changchun

132011

Investigational Site Number :1560014, Jilin

133000

Investigational Site Number :1560057, Yanji

136000

Investigational Site Number :1560010, Siping

200120

Investigational Site Number :1560027, Shanghai

210011

Investigational Site Number :1560066, Nanjing

212001

Investigational Site Number :1560011, Zhenjiang

221002

Investigational Site Number :1560003, Xuzhou

225001

Investigational Site Number :1560065, Yangzhou

250013

Investigational Site Number :1560020, Jinan

255036

Investigational Site Number :1560037, Zibo

300121

Investigational Site Number :1560002, Tianjin

300140

Investigational Site Number :1560053, Tianjin

323000

Investigational Site Number :1560061, Lishui

400013

Investigational Site Number :1560060, Chongqing

410013

Investigational Site Number :1560052, Changsha

412007

Investigational Site Number :1560063, Zhuzhou

414000

Investigational Site Number :1560019, Yueyang

430022

Investigational Site Number :1560047, Wuhan

430033

Investigational Site Number :1560009, Wuhan

430080

Investigational Site Number :1560035, Wuhan

524001

Investigational Site Number :1560005, Zhanjiang

530031

Investigational Site Number :1560055, Nanning

545006

Investigational Site Number :1560071, Liuzhou

570311

Investigational Site Number :1560029, Haikou

610041

Investigational Site Number :1560041, Chengdu

710061

Investigational Site Number :1560022, Xi'an

710068

Investigational Site Number :1560070, Xi'an

750004

Investigational Site Number :1560064, Yinchuan

014010

Investigational Site Number :1560033, Baotou

Unknown

Investigational Site Number :1560025, Bengbu

010017

Investigational Site Number :1560006, Hohhot

010050

Investigational Site Number :1560007, Hohhot

044000

Investigational Site Number :1560062, Yuncheng

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT04669041 - A Study to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia Not Adequately Controlled on Statin Therapy | Biotech Hunter | Biotech Hunter