Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)
A Phase 3 Randomized, Active-comparator-controlled Clinical Study to Evaluate the Efficacy and Safety of Ezetimibe/Atorvastatin Combination Tablet (MK-0653C) as Second Line Lipid Lowering Treatment in Chinese Participants
2 other identifiers
interventional
454
1 country
30
Brief Summary
This study will evaluate the EZ/Ator fixed-dose combination (FDC) tablet (MK-0653C) as second line Low-Density Lipoprotein - Cholesterol (LDL-C) treatment in Chinese participants. The primary hypothesis is that MK-0653C 10/10 mg is superior to atorvastatin 20 mg in percent change from baseline in LDL-C to 12 weeks after treatment.
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 May 2019
30 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
November 29, 2018
CompletedFirst Posted
Study publicly available on registry
December 7, 2018
CompletedStudy Start
First participant enrolled
May 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedResults Posted
Study results publicly available
February 8, 2023
CompletedMay 16, 2024
April 1, 2023
1.8 years
November 29, 2018
March 1, 2022
May 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in LDL-C at Week 12
Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.
Baseline (Day 1) and Week 12
Secondary Outcomes (2)
Percentage of Participants With An Adverse Event (AE)
Up to approximately 17 weeks
Number of Participants Who Discontinued From Study Treatment
Up to approximately 15 weeks
Study Arms (4)
EZ 10 mg/Ator 10 mg
EXPERIMENTALSingle oral dose of EZ10mg/Ator10mg FDC tablet once daily (QD) for 84 days
Atorvastatin 20 mg
ACTIVE COMPARATOR2 atorvastatin 10 mg tablets administered orally, QD for 84 days
EZ 10 mg/Ator 20 mg
EXPERIMENTALSingle oral dose of EZ10mg/Ator20mg FDC tablet QD for 84 days
Atorvastatin 40 mg
ACTIVE COMPARATOR2 atorvastatin 20 mg tablets administered orally, QD for 84 days
Interventions
Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets
A single placebo tablet administered orally QD for 84 days
Two placebo tablets matching atorvastatin administered orally QD for 84 days
Eligibility Criteria
You may qualify if:
- Has hypercholesterolemia diagnosed by investigator according to Chinese Guidelines on Prevention and Treatment of Dyslipidemia in Adults (2016 Edition).
- Has been stabilized on atorvastatin treatment at 10 mg or 20 mg (or other statins with LDL-C lowering efficacy equivalent to atorvastatin) for at least 4 weeks prior to Visit 1.
- If female, is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP), or is a WOCBP who has used a contraceptive consistent with local regulations.
- If male, has used a contraceptive consistent with local regulations.
- Agrees to maintain a stable diet and stable exercise during the study.
You may not qualify if:
- Has uncontrolled hypertriglyceridemia which needs drug intervention or a fasting triglyceride (TG) value ≥500 mg/dL (4.52 mmol/L).
- Is currently treated with statin at dose of equivalent LDL-C lowering effect \>20 mg atorvastatin.
- Has active liver disease
- Has New York Heart Association (NYHA) Class III or IV symptomatic congestive heart failure at Visit 1.
- Has had uncontrolled cardiac arrhythmias, myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, unstable angina, or stroke within 3 months (12 weeks) prior to Visit 1.
- Has homozygous familial hypercholesterolemia or has undergone LDL apheresis.
- Has endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia, e.g., hyper or hypothyroidism, Cushing's syndrome).
- Has had a gastrointestinal tract bypass, or other significant intestinal malabsorption.
- Has a history of cancer within the past 5 years from Visit 1 (except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer).
- Is known to be human immunodeficiency virus (HIV) positive.
- Has hypersensitivity or intolerance to ezetimibe, atorvastatin, the ezetimibe/atorvastatin combination tablet, or any component of these medications or has a condition or situation, which is described as a contraindication in labeling of EZETROL or Lipitor or may interfere with participation in the study.
- Has disorders of the hematologic, digestive, or central nervous systems including cerebrovascular disease and degenerative disease that would limit study evaluation or participation.
- Has a history of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.
- Has a history of myopathy or rhabdomyolysis with ezetimibe or any statin.
- Is a WOCBP who has had a positive urine pregnancy test within 24 hours before the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Study Sites (30)
The First Affiliated Hospital of Baotou Medical College ( Site 0025)
Baotou, Anhui, 014010, China
Beijing Anzhen Hospital. Capital Medical University ( Site 0001)
Beijing, Anhui, 100024, China
Aero Space center hospital ( Site 0003)
Beijing, Beijing Municipality, 100049, China
Beijing Friendship Hospital ( Site 0005)
Beijing, Beijing Municipality, 100050, China
Chongqing General Hospital ( Site 0037)
Chongqing, Chongqing Municipality, 400013, China
Lanzhou University Second Hospital ( Site 0041)
Lanzhou, Gansu, 730030, China
Guangdong General Hospital ( Site 0006)
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital.Sun Yat-sen University ( Site 0007)
Guangzhou, Guangdong, 510080, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 0008)
Guangzhou, Guangdong, 510210, China
Daqing Oilfield General Hospital ( Site 0010)
Daqing, Heilongjiang, 163001, China
The first affiliated Hospital of Harbin Medical University ( Site 0009)
Haerbin, Heilongjiang, 150001, China
The Third Xiangya Hospital of Central South University ( Site 0013)
Changsha, Hunan, 410000, China
Hunan Provincial People's Hospital ( Site 0011)
Changsha, Hunan, 410005, China
Zhongda Hospital Southeast University ( Site 0045)
Nanjing, Jiangsu, 210009, China
The Second Affiliated Hospital of Nanjing Medical University ( Site 0020)
Nanjing, Jiangsu, 210011, China
First Affiliated Hospital of Soochow University ( Site 0048)
Suzhou, Jiangsu, 215006, China
The Affiliated Hospital of Xuzhou Medical University ( Site 0017)
Xuzhou, Jiangsu, 221000, China
Subei People's Hospital ( Site 0040)
Yangzhou, Jiangsu, 225001, China
Second Affiliated Hospital of Nanchang University ( Site 0038)
Nanchang, Jiangxi, 330006, China
Ji Lin Province People Hospital ( Site 0016)
Changchun, Jilin, 130021, China
China-Japan Union Hospital of Jilin University ( Site 0015)
Changchun, Jilin, 130033, China
Central People s Hospital of Siping ( Site 0046)
Siping, Jilin, 136000, China
The People's Hospital of Liaoning Province-Cardiovascular ( Site 0022)
Shenyang, Liaoning, 110016, China
Zhongshan Hospital Fudan University ( Site 0049)
Shanghai, Shanghai Municipality, 200032, China
Shanghai Tongji Hospital ( Site 0031)
Shanghai, Shanghai Municipality, 200065, China
Tianjin Union Medicine Centre ( Site 0032)
Tianjin, Tianjin Municipality, 300121, China
People s Hospital of Lishui City ( Site 0036)
Lishui, Zhejiang, 323000, China
Ningbo First Hospital ( Site 0042)
Ningbo, Zhejiang, 315010, China
Taizhou Hospital of Zhejiang Province ( Site 0035)
Taizhou, Zhejiang, 317000, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 0034)
Wenzhou, Zhejiang, 325000, China
Related Publications (2)
Qian J, Zhang X, Chen J, Ding C, Yang P, Qing L, Liu Y, Chen SS, Ge J. LDL-C Goal Attainment with Fixed-Dose Ezetimibe and Atorvastatin Versus High-Dose Atorvastatin in Chinese Patients: Subgroup Analysis of a Randomized Trial. Adv Ther. 2026 Jan 19. doi: 10.1007/s12325-025-03429-8. Online ahead of print.
PMID: 41553712DERIVEDQian J, Li Z, Zhang X, Chen J, Ding C, Yang P, Liu Y, Shi M, Ren X, Ge J; Phase III Study Investigators. Efficacy and Tolerability of Ezetimibe/Atorvastatin Fixed-dose Combination Versus Atorvastatin Monotherapy in Hypercholesterolemia: A Phase III, Randomized, Active-controlled Study in Chinese Patients. Clin Ther. 2022 Oct;44(10):1282-1296. doi: 10.1016/j.clinthera.2022.08.013. Epub 2022 Sep 29.
PMID: 36182594DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2018
First Posted
December 7, 2018
Study Start
May 27, 2019
Primary Completion
March 17, 2021
Study Completion
April 1, 2021
Last Updated
May 16, 2024
Results First Posted
February 8, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share