HypercholesterolemiaPhase 3NCT03768427

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

A Phase 3 study testing EZ 10 mg/Ator 10 mg, EZ 10 mg/Ator 20 mg and Atorvastatin in people with Hypercholesterolemia, run by Organon and Co at 30 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: EZ 10 mg/Ator 10 mg, EZ 10 mg/Ator 20 mg and Atorvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 454 participants
Where: 30 sitesChina
Study dates: 27 May 2019to 1 Apr 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 29Show fewer

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.

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

China30 sites

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

Other trials in China

About this study

Official title: 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.

Conditions: Hypercholesterolemia
Being tested: EZ 10 mg/Ator 10 mg, EZ 10 mg/Ator 20 mg, Atorvastatin, Placebo for FDC EZ/Ator, Placebo for atorvastatin
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EZ 10 mg/Ator 10 mgCombination product
FDC of EZ10 mg/Ator 10mg
EZ 10 mg/Ator 20 mgCombination product
FDC of EZ10 mg/Ator 20mg
AtorvastatinDrug
Also called Lipitor^®
Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets
Placebo for FDC EZ/AtorDrug
A single placebo tablet administered orally QD for 84 days
Placebo for atorvastatinDrug
Two placebo tablets matching atorvastatin administered orally QD for 84 days

Study groups in NCT03768427
Study group	Role	What they receive
EZ 10 mg/Ator 10 mg	Experimental	Single oral dose of EZ10mg/Ator10mg FDC tablet once daily (QD) for 84 days Receives: Combination Product: EZ 10 mg/Ator 10 mg; Drug: Placebo for FDC EZ/Ator
Atorvastatin 20 mg	Active comparator	2 atorvastatin 10 mg tablets administered orally, QD for 84 days Receives: Drug: Atorvastatin; Drug: Placebo for atorvastatin
EZ 10 mg/Ator 20 mg	Experimental	Single oral dose of EZ10mg/Ator20mg FDC tablet QD for 84 days Receives: Combination Product: EZ 10 mg/Ator 20 mg; Drug: Placebo for FDC EZ/Ator
Atorvastatin 40 mg	Active comparator	2 atorvastatin 20 mg tablets administered orally, QD for 84 days Receives: Drug: Atorvastatin; Drug: Placebo for atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline (Day 1) and Week 12

Secondary outcomes (2)

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.
Measured: 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.
Measured: Up to approximately 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 May 20191 Apr 2021

First posted7 Dec 2018
Study start27 May 2019
Primary completion17 Mar 2021
Study completion1 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 454 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03768427
Sponsor's protocol ID: 0653C-439
Other IDs: MK-0653C-439
Status last verified: Apr 2023
First submitted: 29 Nov 2018
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41553712
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.
PubMed 36182594

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03768427
Acronym / sponsor ID: 0653C-439
Conditions: Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 454 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 27 May 2019 (actual)
Primary completion: 17 Mar 2021 (actual)
Study completion: 1 Apr 2021 (actual)
First posted: 7 Dec 2018 (actual)
Results: Posted 8 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
EZ 10 mg/Ator 10 mg	Experimental	Combination Product: EZ 10 mg/Ator 10 mg, Drug: Placebo for FDC EZ/AtorSingle oral dose of EZ10mg/Ator10mg FDC tablet once daily (QD) for 84 days
Atorvastatin 20 mg	Active comparator	Drug: Atorvastatin, Drug: Placebo for atorvastatin2 atorvastatin 10 mg tablets administered orally, QD for 84 days
EZ 10 mg/Ator 20 mg	Experimental	Combination Product: EZ 10 mg/Ator 20 mg, Drug: Placebo for FDC EZ/AtorSingle oral dose of EZ10mg/Ator20mg FDC tablet QD for 84 days
Atorvastatin 40 mg	Active comparator	Drug: Atorvastatin, Drug: Placebo for atorvastatin2 atorvastatin 20 mg tablets administered orally, QD for 84 days

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (29 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EZ 10 mg/Ator 10 mgFDC of EZ10 mg/Ator 10mg	Combination product	EZ 10 mg/Ator 10 mg
EZ 10 mg/Ator 20 mgFDC of EZ10 mg/Ator 20mg	Combination product	EZ 10 mg/Ator 20 mg
AtorvastatinAlso: Lipitor^®Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets	Drug	Atorvastatin 20 mg, Atorvastatin 40 mg
Placebo for FDC EZ/AtorA single placebo tablet administered orally QD for 84 days	Drug	EZ 10 mg/Ator 10 mg, EZ 10 mg/Ator 20 mg
Placebo for atorvastatinTwo placebo tablets matching atorvastatin administered orally QD for 84 days	Drug	Atorvastatin 20 mg, Atorvastatin 40 mg

Primary outcome

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.

2 secondary outcomes

Percentage of Participants With An Adverse Event (AE)
Time frame: Up to approximately 17 weeks
Number of Participants Who Discontinued From Study Treatment
Time frame: Up to approximately 15 weeks

Results and safety

Results posted to the registry on 8 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg	88	76
Atorvastatin 10mg - Atorvastatin 20 mg	89	85
Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg	137	126
Atorvastatin 20 mg - Atorvastatin 40 mg	140	129

Primary outcome: Percent Change From Baseline in LDL-C at Week 12

Time frame: Baseline (Day 1) and Week 12. Mean (Standard Deviation). Unit: Percent change

Measure	Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg n = 67	Atorvastatin 10mg - Atorvastatin 20 mg n = 77	Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg n = 114	Atorvastatin 20 mg - Atorvastatin 40 mg n = 116
Value	-24.7 (24.9)	-5.3 (22.5)	-23.3 (23.1)	-9.1 (18.2)

Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg vs Atorvastatin 10mg - Atorvastatin 20 mg: Mean Difference (Final Values): -19.5 (95% CI -26.7 to -12.3), p <0.001, Constrained longitudinal model
Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg vs Atorvastatin 20 mg - Atorvastatin 40 mg: Mean Difference (Final Values): -15.9 (95% CI -21.0 to -10.7), p <0.001, Constrained longitudinal model

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 17 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg	2 of 88 (2.3%)	0 of 88 (0%)	0 of 88
Atorvastatin 10mg - Atorvastatin 20 mg	4 of 89 (4.5%)	0 of 89 (0%)	0 of 89
Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg	10 of 137 (7.3%)	7 of 137 (5.1%)	1 of 137
Atorvastatin 20 mg - Atorvastatin 40 mg	6 of 140 (4.3%)	2 of 140 (1.4%)	0 of 140

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41553712Qian 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.
Derived from this study: PubMed 36182594Qian 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.
Individual participant dataSharing planned: No

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EZ 10 mg/Ator 10 mg, EZ 10 mg/Ator 20 mg and Atorvastatin in people with Hypercholesterolemia, run by Organon and Co at 30 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in LDL-C at Week 12 (time frame: Baseline (Day 1) and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03768427, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.