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

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.

Timeline

Start

2020-12-08

Primary completion

2022-06-15

Completion

2022-06-15

Outcome

Met primary endpoint

paper The superiority of SPC R10/E10 over R10 was demonstrated PMID 37770770 ↗

paper LS mean difference of percent change in LDL-C from baseline to week 8: - 13.85% (95% confidence interval [CI] - 20.15% to - 7.56%, P < 0.0001). PMID 37770770 ↗

Publications

• Su Q, Liu Y, Zhang G, Xu L, Wang M, Mei S, Garon G, Wu Y, Lv Q, Ma C. Efficacy and Safety of Single-Pill Combination of Rosuvastatin and Ezetimibe in Chinese Patients with Primary Hypercholesterolemia Inadequately Controlled by Statin Treatment (ROZEL): A Randomized, Double-Blind, Double Dummy, Active-Controlled Phase 3 Clinical Trial. Adv Ther. 2023 Dec;40(12):5285-5299. doi: 10.1007/s12325-023-02666-z. Epub 2023 Sep 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ezetimibe	Unknown	10 mg	Oral
Subject	Rosuvastatin	Small molecule	10 mg	Oral

Indications