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
- Conditions
- Hypercholesterolemia
- Interventions
- Registration Number
- NCT04669041
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To demonstrate the superiority of the single pill combination (SPC) ezetimibe 10 mg/rosuvastatin 10 mg (E10/R10) compared to rosuvastatin 10 mg (R10), in the reduction of low density lipoprotein cholesterol (LDL-C) after 8 weeks.
Secondary Objectives:
* To evaluate the proportion of patients who attain their LDL-C goal.
* To evaluate the effect of SPC (E10/R10) compared to rosuvastatin 10 mg (R10) in reduction of LDL-C at Week 4.
* To evaluate the effect of SPC (E10/R10) compared to R10 on other lipid parameters at Week 4 and Week 8.
* To evaluate the safety of SPC (E10/R10) and R10.
- Detailed Description
Study duration per participants is approximatively 16 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 305
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single pill combination (SPC) Rosuvastatin Once daily rosuvastatin 10 mg for 4 weeks, then once daily SPC ezetimibe 10 mg /rosuvastatin 10 mg (E10/R10) for 8 weeks Single pill combination (SPC) SPC ezetimibe/rosuvastatin Once daily rosuvastatin 10 mg for 4 weeks, then once daily SPC ezetimibe 10 mg /rosuvastatin 10 mg (E10/R10) for 8 weeks Single pill combination (SPC) Placebo Once daily rosuvastatin 10 mg for 4 weeks, then once daily SPC ezetimibe 10 mg /rosuvastatin 10 mg (E10/R10) for 8 weeks Rosuvastatin Rosuvastatin Once daily rosuvastatin 10 mg for 4 weeks, then once daily rosuvastatin 10 mg (R10) for 8 weeks Rosuvastatin Rosuvastatin active capsule Once daily rosuvastatin 10 mg for 4 weeks, then once daily rosuvastatin 10 mg (R10) for 8 weeks Rosuvastatin Placebo Once daily rosuvastatin 10 mg for 4 weeks, then once daily rosuvastatin 10 mg (R10) for 8 weeks
- Primary Outcome Measures
Name Time Method Percent change in measured LDL-C from baseline (the last available measured LDL-C value obtained up to randomization) to Week 8 Baseline to Week 8 The percent change from baseline in measured LDL-C at Week 8 will be analyzed in the modified intent-to-treat (mITT) population using a mixed effect model with repeated measures (MMRM) approach.
- Secondary Outcome Measures
Name Time Method Proportion of patients who attain lipid goal (measured LDL-C <2.6 mmol/L [100 mg/dL]) at Week 8 Week 8 Percent change in measured LDL-C plasma level from baseline to Week 4 Baseline to Week 4 Percent change in total cholesterol (TC) from baseline to Week 8 Baseline to Week 8 Percent change in TG serum levels from baseline to Week 4 Baseline to Week 4 Percent change in high density lipoprotein cholesterol (HDL-C) from baseline to Week 8 Baseline to Week 8 Percent change in TC from baseline to Week 4 Baseline to Week 4 Percent change in triglyceride (TG) serum levels from baseline to Week 8 Baseline to Week 8 Percent change in HDL-C from baseline to Week 4 Baseline to Week 4 Number of patients with adverse events (AEs) Up to 16 weeks (±3 days)
Trial Locations
- Locations (40)
Investigational Site Number :1560006
🇨🇳Hohhot, China
Investigational Site Number :1560045
🇨🇳Changchun, China
Investigational Site Number :1560067
🇨🇳Changchun, China
Investigational Site Number :1560071
🇨🇳Liuzhou, China
Investigational Site Number :1560021
🇨🇳Beijing, China
Investigational Site Number :1560033
🇨🇳Baotou, China
Investigational Site Number :1560001
🇨🇳Beijing, China
Investigational Site Number :1560041
🇨🇳Chengdu, China
Investigational Site Number :1560060
🇨🇳Chongqing, China
Investigational Site Number :1560015
🇨🇳Dalian, China
Investigational Site Number :1560029
🇨🇳Haikou, China
Investigational Site Number :1560007
🇨🇳Hohhot, China
Investigational Site Number :1560020
🇨🇳Jinan, China
Investigational Site Number :1560061
🇨🇳Lishui, China
Investigational Site Number :1560055
🇨🇳Nanning, China
Investigational Site Number :1560027
🇨🇳Shanghai, China
Investigational Site Number :1560034
🇨🇳Shenyang, China
Investigational Site Number :1560002
🇨🇳Tianjin, China
Investigational Site Number :1560053
🇨🇳Tianjin, China
Investigational Site Number :1560047
🇨🇳Wuhan, China
Investigational Site Number :1560022
🇨🇳Xi'An, China
Investigational Site Number :1560070
🇨🇳Xi'an, China
Investigational Site Number :1560065
🇨🇳Yangzhou, China
Investigational Site Number :1560057
🇨🇳Yanji, China
Investigational Site Number :1560019
🇨🇳Yueyang, China
Investigational Site Number :1560005
🇨🇳Zhanjiang, China
Investigational Site Number :1560011
🇨🇳Zhenjiang, China
Investigational Site Number :1560063
🇨🇳Zhuzhou, China
Investigational Site Number :1560037
🇨🇳Zibo, China
Investigational Site Number :1560062
🇨🇳Yuncheng, China
Investigational Site Number :1560025
🇨🇳Bengbu, China
Investigational Site Number :1560068
🇨🇳Beijing, China
Investigational Site Number :1560052
🇨🇳Changsha, China
Investigational Site Number :1560014
🇨🇳Jilin, China
Investigational Site Number :1560010
🇨🇳Siping, China
Investigational Site Number :1560009
🇨🇳Wuhan, China
Investigational Site Number :1560035
🇨🇳Wuhan, China
Investigational Site Number :1560003
🇨🇳Xuzhou, China
Investigational Site Number :1560064
🇨🇳Yinchuan, China
Investigational Site Number :1560066
🇨🇳Nanjing, China