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
A Randomized Double-blinded, Double Dummy, Active-controlled, Parallel Design, Phase 3 Clinical Trial 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
2 other identifiers
interventional
305
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2020
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2020
CompletedStudy Start
First participant enrolled
December 8, 2020
CompletedFirst Posted
Study publicly available on registry
December 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2022
CompletedSeptember 22, 2025
September 1, 2025
1.5 years
December 8, 2020
September 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in measured LDL-C from baseline (the last available measured LDL-C value obtained up to randomization) 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.
Baseline to Week 8
Secondary Outcomes (9)
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 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
- +4 more secondary outcomes
Study Arms (2)
Single pill combination (SPC)
EXPERIMENTALOnce daily rosuvastatin 10 mg for 4 weeks, then once daily SPC ezetimibe 10 mg /rosuvastatin 10 mg (E10/R10) for 8 weeks
Rosuvastatin
ACTIVE COMPARATOROnce daily rosuvastatin 10 mg for 4 weeks, then once daily rosuvastatin 10 mg (R10) for 8 weeks
Interventions
Pharmaceutical form:Tablet Route of administration: Oral
Pharmaceutical form:Tablet Route of administration: Oral
Pharmaceutical form:Capsule Route of administration: Oral
Eligibility Criteria
You may qualify if:
- Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
- Patients with primary hypercholesterolemia.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent.
You may not qualify if:
- Homozygous familial hypercholesterolemia (FH) (clinically or previous genotyping).
- Patient who has received LDL-C plasmapheresis treatment within 2 months prior to the screening visit, or has plans to receive it during the study.
- Recently diagnosed (within 3 months prior to the screening visit) myocardial infarction (MI), unstable angina, myocardial revascularization (percutaneous coronary intervention \[PCI\], coronary artery bypass graft surgery \[CABG\]), transient ischemic attack (TIA), or stroke, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease.
- Planned to undergo scheduled PCI, CABG, carotid or peripheral revascularization during the study.
- Severe hypertension (treated or untreated) with systolic blood pressure (SBP) \>160 mm Hg or diastolic blood pressure (DBP) \>100 mm Hg at study entry.
- History of severe congestive heart failure (New York Heart Association Class IIIb or IV) within the past 12 months.
- Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins, according to Investigator's medical judgement.
- Uncontrolled (as determined by fasting glucose \>180 mg/mL or HbA1c \>9%) or newly diagnosed (within 3 months of study entry) diabetes mellitus at the screening visit.
- History of cancer within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- Conditions/situations such as:
- Patient with a short life expectancy.
- Patient with conditions/concomitant diseases making them non-evaluable for the primary efficacy endpoint, according to Investigator's medical judgement.
- Requirement for concomitant treatment that could bias primary evaluation, according to Investigator's medical judgement.
- Impossibility to meet specific protocol requirements (eg, ability to make study visits).
- Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the study.
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (40)
Investigational Site Number :1560033
Baotou, 014010, China
Investigational Site Number :1560001
Beijing, 100029, China
Investigational Site Number :1560068
Beijing, 100050, China
Investigational Site Number :1560021
Beijing, 101200, China
Investigational Site Number :1560025
Bengbu, China
Investigational Site Number :1560045
Changchun, 130021, China
Investigational Site Number :1560067
Changchun, 130033, China
Investigational Site Number :1560052
Changsha, 410013, China
Investigational Site Number :1560041
Chengdu, 610041, China
Investigational Site Number :1560060
Chongqing, 400013, China
Investigational Site Number :1560015
Dalian, 116033, China
Investigational Site Number :1560029
Haikou, 570311, China
Investigational Site Number :1560006
Hohhot, 010017, China
Investigational Site Number :1560007
Hohhot, 010050, China
Investigational Site Number :1560014
Jilin, 132011, China
Investigational Site Number :1560020
Jinan, 250013, China
Investigational Site Number :1560061
Lishui, 323000, China
Investigational Site Number :1560071
Liuchow, 545006, China
Investigational Site Number :1560066
Nanjing, 210011, China
Investigational Site Number :1560055
Nanning, 530031, China
Investigational Site Number :1560027
Shanghai, 200120, China
Investigational Site Number :1560034
Shenyang, 110016, China
Investigational Site Number :1560010
Siping, 136000, China
Investigational Site Number :1560002
Tianjin, 300121, China
Investigational Site Number :1560053
Tianjin, 300140, China
Investigational Site Number :1560047
Wuhan, 430022, China
Investigational Site Number :1560009
Wuhan, 430033, China
Investigational Site Number :1560035
Wuhan, 430080, China
Investigational Site Number :1560022
Xi'an, 710061, China
Investigational Site Number :1560070
Xi'an, 710068, China
Investigational Site Number :1560003
Xuzhou, 221002, China
Investigational Site Number :1560065
Yangzhou, 225001, China
Investigational Site Number :1560057
Yanji, 133000, China
Investigational Site Number :1560064
Yinchuan, 750004, China
Investigational Site Number :1560019
Yueyang, 414000, China
Investigational Site Number :1560062
Yuncheng, 044000, China
Investigational Site Number :1560005
Zhanjiang, 524001, China
Investigational Site Number :1560011
Zhenjiang, 212001, China
Investigational Site Number :1560063
Zhuzhou, 412007, China
Investigational Site Number :1560037
Zibo, 255036, China
Related Publications (1)
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.
PMID: 37770770DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2020
First Posted
December 16, 2020
Study Start
December 8, 2020
Primary Completion
June 15, 2022
Study Completion
June 15, 2022
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org