HypercholesterolemiaPhase 3NCT02550288

A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)

A Phase 3 study testing Ezetimibe 10 mg and Atorvastatin 10 mg in people with Hypercholesterolemia, run by Organon and Co.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: Ezetimibe 10 mg and Atorvastatin 10 mg
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 309 participants
Where: No sites listed yet
Study dates: 29 Sep 2015to 30 May 2016
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Japanese outpatient with hypercholesterolemia.
Females must be non-reproductive potential or agree to remain abstinent or use (or partner use) two acceptable methods of birth control from date of signed informed consent to the 14 days after the last dose of study drug
Agree to maintain a stable diet that is consistent with the Japan Atherosclerosis Society Guideline 2012 (JAS2012) for prevention of atherosclerotic cardiovascular diseases for the duration of the study

Who cannot join

Uncontrolled hypertension
Type 1 or uncontrolled type 2 diabetes mellitus (treated or untreated)
History of coronary artery disease (CAD) Homozygous familial hypercholesterolemia or has undergone LDL apheresis
Had a gastrointestinal tract bypass, or other significant intestinal malabsorption
History of cancer within the past 5 years except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer
Human immunodeficiency virus (HIV) positive

Show all 15Show fewer

History of drug/ alcohol abuse within the past 5 years or psychiatric illness not adequately controlled and stable on pharmacotherapy
Consumes more than 25 g of alcohol per day
Consumes more than 1L of grapefruit juice per day
Currently following an excessive weight reduction diet
Engaging in a vigorous exercise regimen (e.g.; marathon training, body building training etc.) or intends to start training during the study
Hypersensitivity or intolerance to ezetimibe or atorvastatin
History of myopathy or rhabdomyolysis with ezetimibe or any statin
Pregnant or lactating
Taking any other investigational drugs and/or has taken any investigational drugs within 30 days

About this study

Official title: A Phase III, Randomized, Active Comparator-controlled Clinical Trial to Study the Efficacy and Safety of MK-0653C in Japanese Patients With Hypercholesterolemia

This study will evaluate the efficacy and safety of MK-0653C (Ezetimibe [EZ] 10 mg/Atorvastatin [Atora] 10mg or 20 mg) compared to EZ 10 mg, Atora 10 mg, or Atora 20 mg alone when administered to Japanese participants with hypercholesterolemia. The primary hypothesis is that MK-0653C (EZ 10 mg/Atorva 10 mg) is superior to EZ 10 mg and is superior to Atorva 10 mg and that MK-0653C (EZ 10 mg/Atorva 20 mg) is superior to EZ 10 mg and is superior to Atorva 20 mg in percent change from baseline in low-density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment.

Conditions: Hypercholesterolemia
Being tested: Ezetimibe 10 mg, Atorvastatin 10 mg, Placebo for Ezetimibe 10 mg tablet, Placebo for Atorvastatin 10 mg capsule, Diet control/Daily Exercise
Medical subject headings: Hypercholesterolemia

What participants receive

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

Ezetimibe 10 mgDrug
Atorvastatin 10 mgDrug
Placebo for Ezetimibe 10 mg tabletDrug
Placebo for Atorvastatin 10 mg capsuleDrug
Diet control/Daily ExerciseBehavioural
Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)

Study groups in NCT02550288
Study group	Role	What they receive
Ezetimibe 10 mg	Active comparator	1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. Receives: Drug: Ezetimibe 10 mg; Drug: Placebo for Atorvastatin 10 mg capsule; Behavioral: Diet control/Daily Exercise
Atorvastatin 10 mg	Active comparator	1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. Receives: Drug: Atorvastatin 10 mg; Drug: Placebo for Ezetimibe 10 mg tablet; Drug: Placebo for Atorvastatin 10 mg capsule; Behavioral: Diet control/Daily Exercise
Atorvastatin 20 mg	Active comparator	2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. Receives: Drug: Atorvastatin 10 mg; Drug: Placebo for Ezetimibe 10 mg tablet; Behavioral: Diet control/Daily Exercise
Ezetimibe 10 mg + Atorvastatin 10 mg	Experimental	1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks Receives: Drug: Ezetimibe 10 mg; Drug: Atorvastatin 10 mg; Drug: Placebo for Atorvastatin 10 mg capsule; Behavioral: Diet control/Daily Exercise
Ezetimibe 10 mg + Atorvastatin 20 mg	Experimental	1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks Receives: Drug: Ezetimibe 10 mg; Drug: Atorvastatin 10 mg; Behavioral: Diet control/Daily Exercise

What is being measured

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

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (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 and Week 12
Percentage of Participants Who Experience 1 or More Gastrointestinal-related Adverse Events (AEs)
Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache.
Measured: up to 14 weeks
Percentage of Participants Who Experience 1 or More Gallbladder-related AEs
Gallbladder-related AEs included Bile Duct Obstruction, Bile Duct Stone, Bile Duct Stenosis, Biliary Colic, Cholangitis, Cholecystectomy, Cholecystitis, Cholelithiasis, Gallbladder Disorder, Gallbladder Perforation, Hepatic Pain, and Hydrocholecystis.
Measured: up to 14 weeks
Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs
Allergic Reaction or Rash AEs included Allergy to Arthropod Sting, Anaphylactoid Reaction, Anaphylactic Reaction, Anaphylatic Shock, Anaphylactoid Shock, Angioedema, Conjunctivitis Allergic, Contrast Media Reaction, Dermatitis, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Contact, Dermatitis Psoriasiform, Drug Hypersensitivity, Eczema, Eosinophila, Erythema, Eye Allergy, Face Oedema, Hypersensitivity, Mechanical Urticaria, Palmar Erythema, Periorbital Oedema, Photodermatosis, Photosensitivity Allergic reaction, Photosensitivity Reaction, Pigmentation Disorder, Pruritus, Pruritus Generalised, Rash, Rash Erythematous, Rash Follicular, Rash Generalised, Rash Maculo-Papular, Rash Papulosquamous, Rash Pruritic, Rash Pustular, Rash Vesicular, Rhinitis, Rhinitis Allergic, Rosacea, Skin Exfoliation, Skin Disorder, Skin Hyperpigmentation, Skin Lesion, Skin Mass, Skin Ulcer, Subcutaneous Nodule, Swelling Face, Systemic Lupus Erythematosus Rash, Urticaria.
Measured: up to 14 weeks
Percentage of Participants Who Experience 1 or More Hepatitis-related AEs
Hepatitis-related AEs included Cholestasis, Cytolytic Hepatitis, Hepatic Cyst, Hepatic Failure, Hepatic Lesion, Hepatic Necrosis, Hepatitis, Hepatitis Cholestatic, Hepatitis Fulminant, Hepatitis Infectious, Hepatocellular Injury, Hepatomegaly, Jaundice, Jaundice Cholestatic.
Measured: up to 14 weeks
Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal (ULN)
Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT that were 3 x ULN or greater were recorded. The ALT ULN was 40 U/L.
Measured: up to 12 weeks
Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times ULN
Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 3 x ULN or greater were recorded. The AST ULN was 40 U/L.
Measured: up to 12 weeks
Percentage of Participants Who Experience Consecutive Elevations in ALT and/or AST ≥3 Times ULN
Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 3 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.
Measured: up to 12 weeks
Percentage of Participants Who Experience Consecutive Elevations in ALT ≥5 Times ULN
Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of ALT that was 5x ULN or greater were recorded. The ALT ULN was 40 U/L.
Measured: up to 12 weeks
Percentage of Participants Who Experience Consecutive Elevations in AST ≥5 Times ULN
Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessment of AST that was 5x ULN or greater were recorded. AST ULN was 40 U/L.
Measured: up to 12 weeks
Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥5 Times ULN
Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 5 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.
Measured: up to 12 weeks
Percentage of Participants Who Experience Consecutive Elevations in ALT ≥10 Times ULN
Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of ALT that was 10x ULN or greater were recorded. The ALT ULN was 40 U/L.
Measured: up to 12 weeks
Percentage of Participants Who Experience Consecutive Elevations in AST ≥10 Times ULN
Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 10x ULN or greater were recorded. The AST ULN was 40 U/L.
Measured: up to 12 weeks
Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥10 Times ULN
Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.
Measured: up to 12 weeks
Percentage of Participants With Potential Hy's Law Condition
Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations >3xULN, with serum alkaline phosphatase <2xULN and total bilirubin (TBL) ≥2xULN) was summarized. The ALT and AST ULNs were 40 U/L. The ULN for alkaline phosphatase was 359 IU/L and the ULN for total bilirubin was 1.2 mg/dL.
Measured: up to 12 weeks
Percentage of Participants Who Have Elevations in Creatine Kinase (CK) ≥10xULN
Participants had creatine phosphokinase (CK) levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.
Measured: up to 12 weeks
Percentage of Participants Who Have Elevations in CK ≥10xULN With Muscle Symptoms
Participants had CK levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.
Measured: up to 12 weeks
Percentage of Participants Who Have Elevations in CK ≥10xULN and Drug-Related Muscle Symptoms
Participants had CK levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly-related to study drug were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.
Measured: up to 12 weeks

Timeline

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

29 Sep 201530 May 2016

First posted15 Sep 2015 (estimated)
Study start29 Sep 2015
Primary completion30 May 2016
Study completion30 May 2016

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 (1)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: 309 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02550288
Sponsor's protocol ID: 0653C-383
Other IDs: 153060
Status last verified: Feb 2022
First submitted: 14 Sep 2015
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Teramoto T, Yokote K, Nishida C, Tershakovec AM, Oshima N, Takase T, Hirano T, Lee R, Johnson-Levonas AO. A phase III, clinical trial to study the efficacy and tolerability of ezetimibe plus atorvastatin combination therapy in Japanese patients with hypercholesterolemia: a randomized, double-blind comparative study. J Clin Therapeut Med. 2017;33(7):551-567

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?

Official record

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 III, Randomized, Active Comparator-controlled Clinical Trial to Study the Efficacy and Safety of MK-0653C in Japanese Patients With Hypercholesterolemia
ClinicalTrials.gov ID: NCT02550288
Acronym / sponsor ID: 0653C-383
Conditions: Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 309 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 29 Sep 2015 (actual)
Primary completion: 30 May 2016 (actual)
Study completion: 30 May 2016 (actual)
First posted: 15 Sep 2015 (estimated)
Results: Posted 21 Jun 2017

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: 5

Arm	Type	Receives
Ezetimibe 10 mg	Active comparator	Drug: Ezetimibe 10 mg, Drug: Placebo for Atorvastatin 10 mg capsule, Behavioral: Diet control/Daily Exercise1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
Atorvastatin 10 mg	Active comparator	Drug: Atorvastatin 10 mg, Drug: Placebo for Ezetimibe 10 mg tablet, Drug: Placebo for Atorvastatin 10 mg capsule, Behavioral: Diet control/Daily Exercise1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
Atorvastatin 20 mg	Active comparator	Drug: Atorvastatin 10 mg, Drug: Placebo for Ezetimibe 10 mg tablet, Behavioral: Diet control/Daily Exercise2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
Ezetimibe 10 mg + Atorvastatin 10 mg	Experimental	Drug: Ezetimibe 10 mg, Drug: Atorvastatin 10 mg, Drug: Placebo for Atorvastatin 10 mg capsule, Behavioral: Diet control/Daily Exercise1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
Ezetimibe 10 mg + Atorvastatin 20 mg	Experimental	Drug: Ezetimibe 10 mg, Drug: Atorvastatin 10 mg, Behavioral: Diet control/Daily Exercise1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Japanese outpatient with hypercholesterolemia.
Females must be non-reproductive potential or agree to remain abstinent or use (or partner use) two acceptable methods of birth control from date of signed informed consent to the 14 days after the last dose of study drug
Agree to maintain a stable diet that is consistent with the Japan Atherosclerosis Society Guideline 2012 (JAS2012) for prevention of atherosclerotic cardiovascular diseases for the duration of the study

Key exclusion criteria (15 listed)

Uncontrolled hypertension
Type 1 or uncontrolled type 2 diabetes mellitus (treated or untreated)
History of coronary artery disease (CAD) Homozygous familial hypercholesterolemia or has undergone LDL apheresis
Had a gastrointestinal tract bypass, or other significant intestinal malabsorption
History of cancer within the past 5 years except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer

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
Ezetimibe 10 mg	Drug	Ezetimibe 10 mg, Ezetimibe 10 mg + Atorvastatin 10 mg, Ezetimibe 10 mg + Atorvastatin 20 mg
Atorvastatin 10 mg	Drug	Atorvastatin 10 mg, Atorvastatin 20 mg, Ezetimibe 10 mg + Atorvastatin 10 mg, Ezetimibe 10 mg + Atorvastatin 20 mg
Placebo for Ezetimibe 10 mg tablet	Drug	Atorvastatin 10 mg, Atorvastatin 20 mg
Placebo for Atorvastatin 10 mg capsule	Drug	Atorvastatin 10 mg, Ezetimibe 10 mg, Ezetimibe 10 mg + Atorvastatin 10 mg
Diet control/Daily ExerciseDiet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)	Behavioural	Atorvastatin 10 mg, Atorvastatin 20 mg, Ezetimibe 10 mg, Ezetimibe 10 mg + Atorvastatin 10 mg, Ezetimibe 10 mg + Atorvastatin 20 mg

Primary outcome

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline 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.
Percentage of Participants Who Experience 1 or More Gastrointestinal-related Adverse Events (AEs)
Time frame: up to 14 weeks
Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache.
Percentage of Participants Who Experience 1 or More Gallbladder-related AEs
Time frame: up to 14 weeks
Gallbladder-related AEs included Bile Duct Obstruction, Bile Duct Stone, Bile Duct Stenosis, Biliary Colic, Cholangitis, Cholecystectomy, Cholecystitis, Cholelithiasis, Gallbladder Disorder, Gallbladder Perforation, Hepatic Pain, and Hydrocholecystis.
Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs
Time frame: up to 14 weeks
Allergic Reaction or Rash AEs included Allergy to Arthropod Sting, Anaphylactoid Reaction, Anaphylactic Reaction, Anaphylatic Shock, Anaphylactoid Shock, Angioedema, Conjunctivitis Allergic, Contrast Media Reaction, Dermatitis, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Contact, Dermatitis Psoriasiform, Drug Hypersensitivity, Eczema, Eosinophila, Erythema, Eye Allergy, Face Oedema, Hypersensitivity, Mechanical Urticaria, Palmar Erythema, Periorbital Oedema, Photodermatosis, Photosensitivity Allergic reaction, Photosensitivity Reaction, Pigmentation Disorder, Pruritus, Pruritus Generalised, Rash, Rash Erythematous, Rash Follicular, Rash Generalised, Rash Maculo-Papular, Rash Papulosquamous, Rash Pruritic, Rash Pustular, Rash Vesicular, Rhinitis, Rhinitis Allergic, Rosacea, Skin Exfoliation, Skin Disorder, Skin Hyperpigmentation, Skin Lesion, Skin Mass, Skin Ulcer, Subcutaneous Nodule, Swelling Face, Systemic Lupus Erythematosus Rash, Urticaria.
Percentage of Participants Who Experience 1 or More Hepatitis-related AEs
Time frame: up to 14 weeks
Hepatitis-related AEs included Cholestasis, Cytolytic Hepatitis, Hepatic Cyst, Hepatic Failure, Hepatic Lesion, Hepatic Necrosis, Hepatitis, Hepatitis Cholestatic, Hepatitis Fulminant, Hepatitis Infectious, Hepatocellular Injury, Hepatomegaly, Jaundice, Jaundice Cholestatic.
Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal (ULN)
Time frame: up to 12 weeks
Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT that were 3 x ULN or greater were recorded. The ALT ULN was 40 U/L.
Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times ULN
Time frame: up to 12 weeks
Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 3 x ULN or greater were recorded. The AST ULN was 40 U/L.
Percentage of Participants Who Experience Consecutive Elevations in ALT and/or AST ≥3 Times ULN
Time frame: up to 12 weeks
Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 3 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.
Percentage of Participants Who Experience Consecutive Elevations in ALT ≥5 Times ULN
Time frame: up to 12 weeks
Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of ALT that was 5x ULN or greater were recorded. The ALT ULN was 40 U/L.
Percentage of Participants Who Experience Consecutive Elevations in AST ≥5 Times ULN
Time frame: up to 12 weeks
Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessment of AST that was 5x ULN or greater were recorded. AST ULN was 40 U/L.
Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥5 Times ULN
Time frame: up to 12 weeks
Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 5 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.
Percentage of Participants Who Experience Consecutive Elevations in ALT ≥10 Times ULN
Time frame: up to 12 weeks
Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of ALT that was 10x ULN or greater were recorded. The ALT ULN was 40 U/L.
Percentage of Participants Who Experience Consecutive Elevations in AST ≥10 Times ULN
Time frame: up to 12 weeks
Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 10x ULN or greater were recorded. The AST ULN was 40 U/L.
Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥10 Times ULN
Time frame: up to 12 weeks
Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.
Percentage of Participants With Potential Hy's Law Condition
Time frame: up to 12 weeks
Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations >3xULN, with serum alkaline phosphatase <2xULN and total bilirubin (TBL) ≥2xULN) was summarized. The ALT and AST ULNs were 40 U/L. The ULN for alkaline phosphatase was 359 IU/L and the ULN for total bilirubin was 1.2 mg/dL.
Percentage of Participants Who Have Elevations in Creatine Kinase (CK) ≥10xULN
Time frame: up to 12 weeks
Participants had creatine phosphokinase (CK) levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.
Percentage of Participants Who Have Elevations in CK ≥10xULN With Muscle Symptoms
Time frame: up to 12 weeks
Participants had CK levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.
Percentage of Participants Who Have Elevations in CK ≥10xULN and Drug-Related Muscle Symptoms
Time frame: up to 12 weeks
Participants had CK levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly-related to study drug were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.

Results and safety

Results posted to the registry on 21 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ezetimibe 10 mg	35	33
Atorvastatin 10 mg	68	65
Atorvastatin 20 mg	69	68
Ezetimibe 10 mg + Atorvastatin 10 mg	68	65
Ezetimibe 10 mg + Atorvastatin 20 mg	69	66

Primary outcome: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12

Time frame: Baseline and Week 12. Least squares mean (95% Confidence Interval). Unit: Percentage Change

Measure	Ezetimibe 10 mg n = 35	Atorvastatin 10 mg n = 68	Atorvastatin 20 mg n = 68	Ezetimibe 10 mg + Atorvastatin 10 mg n = 68	Ezetimibe 10 mg + Atorvastatin 20 mg n = 69
Value	-19.3 (-22.7 to -15.8)	-44.0 (-46.5 to -41.6)	-49.1 (-51.5 to -46.7)	-55.6 (-58.0 to -53.2)	-59.2 (-61.6 to -56.8)

Ezetimibe 10 mg vs Ezetimibe 10 mg + Atorvastatin 10 mg: Difference in Least Squares Means: -36.3 (95% CI -40.5 to -32.2), p <0.001, Constrained longitudinal data analysis
Atorvastatin 10 mg vs Ezetimibe 10 mg + Atorvastatin 10 mg: Difference in Least Squares Means: -11.6 (95% CI -14.9 to -8.2), p <0.001, Constrained longitudinal data analysis
Ezetimibe 10 mg vs Ezetimibe 10 mg + Atorvastatin 20 mg: Difference in Least Squares Means: -39.9 (95% CI -44.1 to -35.8), p <0.001, Constrained longitudinal data analysis

Population analysed: All participants who received at least 1 dose of study treatment, and had a baseline observation or at least 1 post-baseline observation. One participant who received misallocated study medication during placebo run-in period was excluded from the main population for the analysis of efficacy data.

Primary outcome: Percentage of Participants Who Experience 1 or More Gastrointestinal-related Adverse Events (AEs)

Time frame: up to 14 weeks. Number. Unit: Percentage of Participants

Measure	Ezetimibe 10 mg n = 35	Atorvastatin 10 mg n = 68	Atorvastatin 20 mg n = 69	Ezetimibe 10 mg + Atorvastatin 10 mg n = 68	Ezetimibe 10 mg + Atorvastatin 20 mg n = 69
Value	5.7	0.0	8.7	7.4	7.2

Population analysed: All randomized participants who received at least 1 dose of actual study treatment.

Primary outcome: Percentage of Participants Who Experience 1 or More Gallbladder-related AEs

Time frame: up to 14 weeks. Number. Unit: Percentage of Participants

Measure	Ezetimibe 10 mg n = 35	Atorvastatin 10 mg n = 68	Atorvastatin 20 mg n = 69	Ezetimibe 10 mg + Atorvastatin 10 mg n = 68	Ezetimibe 10 mg + Atorvastatin 20 mg n = 69
Value	0.0	1.5	0.0	0.0	0.0

Population analysed: All randomized participants who received at least 1 dose of actual study treatment.

Primary outcome: Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs

Time frame: up to 14 weeks. Number. Unit: Percentage of Participants

Measure	Ezetimibe 10 mg n = 35	Atorvastatin 10 mg n = 68	Atorvastatin 20 mg n = 69	Ezetimibe 10 mg + Atorvastatin 10 mg n = 68	Ezetimibe 10 mg + Atorvastatin 20 mg n = 69
Value	0.0	2.9	2.9	0.0	1.4

Population analysed: All randomized participants who received at least 1 dose of actual study treatment.

Adverse events

Time frame: up to 14 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ezetimibe 10 mg	0 of 35 (0%)	5 of 35 (14.3%)	Not reported
Atorvastatin 10 mg	1 of 68 (1.5%)	5 of 68 (7.4%)	Not reported
Atorvastatin 20 mg	0 of 69 (0%)	9 of 69 (13%)	Not reported
Ezetimibe 10 mg + Atorvastatin 10 mg	0 of 68 (0%)	11 of 68 (16.2%)	Not reported
Ezetimibe 10 mg + Atorvastatin 20 mg	0 of 69 (0%)	16 of 69 (23.2%)	Not reported

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.
Results publicationTeramoto T, Yokote K, Nishida C, Tershakovec AM, Oshima N, Takase T, Hirano T, Lee R, Johnson-Levonas AO. A phase III, clinical trial to study the efficacy and tolerability of ezetimibe plus atorvastatin combination therapy in Japanese patients with hypercholesterolemia: a randomized, double-blind comparative study. J Clin Therapeut Med. 2017;33(7):551-567
Individual participant dataSharing planned: No

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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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ezetimibe 10 mg and Atorvastatin 10 mg in people with Hypercholesterolemia, run by Organon and Co.

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 3 inclusion and 15 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.

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 21 Jun 2017). 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 Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (time frame: Baseline and Week 12). The study lists 18 primary outcomes in all. 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 NCT02550288, which also lists 1 linked publication.

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.