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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0653C-439 | Other Identifier | Merck Protocol Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EZ 10 mg/Ator 10 mg | Experimental | Single oral dose of EZ10mg/Ator10mg FDC tablet once daily (QD) for 84 days |
|
| Atorvastatin 20 mg | Active Comparator | 2 atorvastatin 10 mg tablets administered orally, QD for 84 days |
|
| EZ 10 mg/Ator 20 mg | Experimental | Single oral dose of EZ10mg/Ator20mg FDC tablet QD for 84 days |
|
| Atorvastatin 40 mg | Active Comparator | 2 atorvastatin 20 mg tablets administered orally, QD for 84 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EZ 10 mg/Ator 10 mg | Combination Product | FDC of EZ10 mg/Ator 10mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With An Adverse Event (AE) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
weeks.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Baotou Medical College ( Site 0025) | Baotou | Anhui | 014010 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41553712 | Derived | 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 Mar;43(3):1187-1198. doi: 10.1007/s12325-025-03429-8. Epub 2026 Jan 19. | |
| 36182594 | Derived |
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Chinese participants with Hypercholesterolemia inadequately controlled with 10 mg or 20 mg atorvastatin (Ator) monotherapy were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg | Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2018 |
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| EZ 10 mg/Ator 20 mg |
| Combination Product |
FDC of EZ10 mg/Ator 20mg |
|
| Atorvastatin | Drug | Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets |
|
|
| Placebo for FDC EZ/Ator | Drug | A single placebo tablet administered orally QD for 84 days |
|
| Placebo for atorvastatin | Drug | Two placebo tablets matching atorvastatin administered orally QD for 84 days |
|
| Up to approximately 17 weeks |
| Number of Participants Who Discontinued From Study Treatment | The number of participants who discontinued treatment over the 12-week treatment period was assessed. | Up to approximately 15 weeks |
| 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 |
| Qian 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. |
| Atorvastatin 10mg - Atorvastatin 20 mg |
Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. |
| FG002 | Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg | Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. |
| FG003 | Atorvastatin 20 mg - Atorvastatin 40 mg | Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg | Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. |
| BG001 | Atorvastatin 10mg - Atorvastatin 20 mg | Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. |
| BG002 | Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg | Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. |
| BG003 | Atorvastatin 20 mg - Atorvastatin 40 mg | Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Low-Density Lipoprotein Cholesterol (LDL-C) | Mean | Standard Deviation | mg/dL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants who took at least one dose of study treatment, and have at least one post treatment observation of the respective endpoint (Baseline and Week 12) during the treatment period. | Posted | Mean | Standard Deviation | Percent change | Baseline (Day 1) and Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With An Adverse Event (AE) | 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. | All randomized participants who received at least one dose of study treatment. | Posted | Number | Percentage of Participants | Up to approximately 17 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinued From Study Treatment | The number of participants who discontinued treatment over the 12-week treatment period was assessed. | All randomized participants who received at least one dose of study treatment. | Posted | Number | Number of Participants | Up to approximately 15 weeks |
|
Up to 17 weeks
Serious AEs and Other AEs are presented for all participants who received ≥1 dose of study medication. All-Cause Mortality is presented for all participants randomized.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg | Participants had a 5-week run-in of atorvastatin 10 mg once daily (QD). They then received a single oral dose of ezetimibe (EZ) 10 mg/Ator 10 mg fixed dose combination (FDC) tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. | 0 | 88 | 2 | 88 | 0 | 88 |
| EG001 | Atorvastatin 10mg - Atorvastatin 20 mg | Participants had a 5-week run-in of atorvastatin 10 mg QD. They then received 2 atorvastatin 20 mg tablets QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. | 0 | 89 | 4 | 89 | 0 | 89 |
| EG002 | Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg | Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. | 1 | 137 | 10 | 137 | 7 | 137 |
| EG003 | Atorvastatin 20 mg - Atorvastatin 40 mg | Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. | 0 | 140 | 6 | 140 | 2 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Ovarian granulosa cell tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Mar 1, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Difference in least squares mean is Atorvastatin 10 mg - EZ 10 mg/Ator 10 mg minus Atorvastatin 10mg - Atorvastatin 20 mg. |
| This statistical analysis was performed by fitting a constrained longitudinal model adjusting for time and the interaction of time by treatment, and time by baseline disease risk category, including all participants with baseline data (137 participants in arm "Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg" and 140 participants in arm "Atorvastatin 20 mg - Atorvastatin 40 mg"). | Constrained longitudinal model | <0.001 | Mean Difference (Final Values) | -15.9 | 2-Sided | 95 | -21.0 | -10.7 | Other | Difference in least squares mean | Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg minus Atorvastatin 20 mg - Atorvastatin 40 mg. |
Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received a single oral dose of EZ 10 mg/Ator 20 mg FDC tablet QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days.
| OG003 | Atorvastatin 20 mg - Atorvastatin 40 mg | Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. |
|
|
| OG003 | Atorvastatin 20 mg - Atorvastatin 40 mg | Participants had a 5-week run-in of atorvastatin 20 mg QD. They then received 2 atorvastatin 20 mg tablets administered orally, QD, and 1 placebo tablet matched to active atorvastatin tablet QD for 84 days. |
|
|