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 (ROZEL)

  • STATUS
    Not Recruiting
  • participants needed
    296
  • sponsor
    Sanofi
Updated on 1 July 2022
rosuvastatin
hypercholesterolemia
ezetimibe
statin therapy
lipoprotein cholesterol
cholesterol measurement
hmg-coa reductase inhibitors
rosuvastatin 10 mg

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.

Description

Study duration per participants is approximatively 16 weeks.

Details
Condition Hypercholesterolemia
Treatment Placebo, Rosuvastatin, SPC ezetimibe/rosuvastatin, Rosuvastatin active capsule
Clinical Study IdentifierNCT04669041
SponsorSanofi
Last Modified on1 July 2022

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