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

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Rosuvastatin; Drug: SPC ezetimibe/rosuvastatin; Drug: Rosuvastatin active capsule; Drug: Placebo

• 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.

Study Timeline

• Study Start: 2020-12-08
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-16
• Status Verified: 2022-06
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

Inclusion Criteria

Not provided

Exclusion Criteria

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 :1560033; 🇨🇳 Baotou, China

Investigational Site Number :1560001; 🇨🇳 Beijing, China

Investigational Site Number :1560068; 🇨🇳 Beijing, China

Investigational Site Number :1560021; 🇨🇳 Beijing, China

Investigational Site Number :1560025; 🇨🇳 Bengbu, China

Investigational Site Number :1560045; 🇨🇳 Changchun, China

Investigational Site Number :1560067; 🇨🇳 Changchun, China

Investigational Site Number :1560052; 🇨🇳 Changsha, China

Investigational Site Number :1560041; 🇨🇳 Chengdu, China

Investigational Site Number :1560060; 🇨🇳 Chongqing, China

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