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

• Status: Recruiting
• Trial end date: 2022-03-01

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.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: Ezetimibe; Rosuvastatin Calcium