Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)

May 8, 2024 updated by: Organon and Co

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
454

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Baotou, Anhui, China, 014010
        • The First Affiliated Hospital of Baotou Medical College ( Site 0025)
      • Beijing, Anhui, China, 100024
        • Beijing Anzhen Hospital. Capital Medical University ( Site 0001)
    • Beijing
      • Beijing, Beijing, China, 100049
        • Aero Space center hospital ( Site 0003)
      • Beijing, Beijing, China, 100050
        • Beijing Friendship Hospital ( Site 0005)
    • Chongqing
      • Chongqing, Chongqing, China, 400013
        • Chongqing General Hospital ( Site 0037)
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Lanzhou University Second Hospital ( Site 0041)
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital ( Site 0006)
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital.Sun Yat-sen University ( Site 0007)
      • Guangzhou, Guangdong, China, 510210
        • Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 0008)
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163001
        • Daqing Oilfield General Hospital ( Site 0010)
      • Haerbin, Heilongjiang, China, 150001
        • The first affiliated Hospital of Harbin Medical University ( Site 0009)
    • Hunan
      • Changsha, Hunan, China, 410000
        • The Third Xiangya Hospital of Central South University ( Site 0013)
      • Changsha, Hunan, China, 410005
        • Hunan Provincial People's Hospital ( Site 0011)
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital Southeast University ( Site 0045)
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University ( Site 0020)
      • Suzhou, Jiangsu, China, 215006
        • First Affiliated Hospital of Soochow University ( Site 0048)
      • Xuzhou, Jiangsu, China, 221000
        • The Affiliated Hospital of Xuzhou Medical University ( Site 0017)
      • Yangzhou, Jiangsu, China, 225001
        • Subei People's Hospital ( Site 0040)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Second Affiliated Hospital of Nanchang University ( Site 0038)
    • Jilin
      • Changchun, Jilin, China, 130021
        • Ji Lin Province People Hospital ( Site 0016)
      • Changchun, Jilin, China, 130033
        • China-Japan Union Hospital of Jilin University ( Site 0015)
      • Siping, Jilin, China, 136000
        • Central People s Hospital of Siping ( Site 0046)
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • The People's Hospital of Liaoning Province-Cardiovascular ( Site 0022)
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital Fudan University ( Site 0049)
      • Shanghai, Shanghai, China, 200065
        • Shanghai Tongji Hospital ( Site 0031)
    • Tianjin
      • Tianjin, Tianjin, China, 300121
        • Tianjin Union Medicine Centre ( Site 0032)
    • Zhejiang
      • Lishui, Zhejiang, China, 323000
        • People s Hospital of Lishui City ( Site 0036)
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital ( Site 0042)
      • Taizhou, Zhejiang, China, 317000
        • Taizhou Hospital of Zhejiang Province ( Site 0035)
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University ( Site 0034)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Is currently taking medications that are potent modulators of cytochrome P-450 3A4 (CYP3A4) including: cyclosporine, systemically administered azole antifungals (e.g., ketoconazole, fluconazole, and itraconazole), macrolide antibiotics (e.g., clarithromycin, and erythromycin), protease inhibitors (e.g., ritonavir, saquinavir, and lopinavir), grapefruit or juice of grapefruit (200 ml/day for >3 times per week)
  • Is taking any cyclical hormones (e.g., cyclical oral contraceptives, cyclical hormone replacement), including the combination of ethinyl estradiol and norethisterone, or non-cyclical hormones, including non-cyclical hormone replacement therapy (HRT) or any estrogen antagonist/agonist within 8 weeks.
  • Note: If participant has been treated with a stable regimen of non-cyclical HRT for > 8 weeks and agree to continue this regimen for the duration of the trial, concomitant therapy is acceptable.
  • Is receiving treatment with systemic corticosteroids (intravenous, intramuscular and oral steroids).
  • Is treated with psyllium, other fiber-based laxatives, phytosterol margarine, and herbal medicine and/or over the counter (OTC) therapies that are known to affect serum lipids.
  • Note: If participant has been treated with a stable regimen for > 8 weeks and agrees to continue this regimen for the duration of the trial, concomitant therapy is acceptable.
  • Is treated with an anti-obesity drug (e.g. mazindol) within 12 weeks prior to Visit 1.
  • Is treated with warfarin or warfarin-like anticoagulants and has not been on a stable dose with a stable International Normalized Ratio (INR) for at least 6 weeks.

weeks.

  • Has taken lipid-lowering agents (except probucol) including, Cholestin, bile acid sequestrants, ezetimibe, fibrates or niacin (>200 mg/day), proprotein convertases subtilisin/kexin type 9 (PCSK9) inhibitors within 6 weeks prior to Visit 1.
  • Has taken probucol within 10 weeks prior to Visit 1.
  • Has been treated with any other investigational drug within 30 days.
  • Currently follows an excessive weight reduction diet.
  • Currently engages in a vigorous exercise regimen (e.g., marathon training, body building training) or intends to start training during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EZ 10 mg/Ator 10 mg
Single oral dose of EZ10mg/Ator10mg FDC tablet once daily (QD) for 84 days
Combination product: EZ 10 mg/Ator 10 mg
FDC of EZ10 mg/Ator 10mg
Drug: Placebo for FDC EZ/Ator
A single placebo tablet administered orally QD for 84 days
Active Comparator: Atorvastatin 20 mg
2 atorvastatin 10 mg tablets administered orally, QD for 84 days
Drug: Atorvastatin
Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets
Other Names:
  • Lipitor^®
Drug: Placebo for atorvastatin
Two placebo tablets matching atorvastatin administered orally QD for 84 days
Experimental: EZ 10 mg/Ator 20 mg
Single oral dose of EZ10mg/Ator20mg FDC tablet QD for 84 days
Drug: Placebo for FDC EZ/Ator
A single placebo tablet administered orally QD for 84 days
Combination product: EZ 10 mg/Ator 20 mg
FDC of EZ10 mg/Ator 20mg
Active Comparator: Atorvastatin 40 mg
2 atorvastatin 20 mg tablets administered orally, QD for 84 days
Drug: Atorvastatin
Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets
Other Names:
  • Lipitor^®
Drug: Placebo for atorvastatin
Two placebo tablets matching atorvastatin administered orally QD for 84 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in LDL-C at Week 12
Time Frame: Baseline (Day 1) and 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With An Adverse Event (AE)
Time Frame: Up to approximately 17 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 17 weeks
Number of Participants Who Discontinued From Study Treatment
Time Frame: Up to approximately 15 weeks
The number of participants who discontinued treatment over the 12-week treatment period was assessed.
Up to approximately 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Organon and Co

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0653C-439
  • MK-0653C-439 (Other Identifier: Merck Protocol Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings