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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ezetimibe 10 mg
Atorvastatin 10 mg
Placebo for Ezetimibe 10 mg tablet
Placebo for Atorvastatin 10 mg capsule
Diet control/Daily Exercise
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Ezetimibe 10 mg

    Atorvastatin 10 mg

    Atorvastatin 20 mg

    Ezetimibe 10 mg + Atorvastatin 10 mg

    Ezetimibe 10 mg + Atorvastatin 20 mg

    Arm Description

    1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.

    1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.

    2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.

    1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks

    1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 14, 2015
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02550288
    Brief Title
    A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    September 29, 2015 (Actual)
    Primary Completion Date
    May 30, 2016 (Actual)
    Study Completion Date
    May 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    309 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ezetimibe 10 mg
    Arm Type
    Active Comparator
    Arm Description
    1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
    Arm Title
    Atorvastatin 10 mg
    Arm Type
    Active Comparator
    Arm Description
    1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
    Arm Title
    Atorvastatin 20 mg
    Arm Type
    Active Comparator
    Arm Description
    2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
    Arm Title
    Ezetimibe 10 mg + Atorvastatin 10 mg
    Arm Type
    Experimental
    Arm Description
    1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
    Arm Title
    Ezetimibe 10 mg + Atorvastatin 20 mg
    Arm Type
    Experimental
    Arm Description
    1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ezetimibe 10 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin 10 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for Ezetimibe 10 mg tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for Atorvastatin 10 mg capsule
    Intervention Type
    Behavioral
    Intervention Name(s)
    Diet control/Daily Exercise
    Intervention Description
    Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
    Description
    Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.
    Time Frame
    Baseline and Week 12
    Title
    Percentage of Participants Who Experience 1 or More Gastrointestinal-related Adverse Events (AEs)
    Description
    Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache.
    Time Frame
    up to 14 weeks
    Title
    Percentage of Participants Who Experience 1 or More Gallbladder-related AEs
    Description
    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.
    Time Frame
    up to 14 weeks
    Title
    Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs
    Description
    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.
    Time Frame
    up to 14 weeks
    Title
    Percentage of Participants Who Experience 1 or More Hepatitis-related AEs
    Description
    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.
    Time Frame
    up to 14 weeks
    Title
    Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal (ULN)
    Description
    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.
    Time Frame
    up to 12 weeks
    Title
    Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times ULN
    Description
    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.
    Time Frame
    up to 12 weeks
    Title
    Percentage of Participants Who Experience Consecutive Elevations in ALT and/or AST ≥3 Times ULN
    Description
    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.
    Time Frame
    up to 12 weeks
    Title
    Percentage of Participants Who Experience Consecutive Elevations in ALT ≥5 Times ULN
    Description
    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.
    Time Frame
    up to 12 weeks
    Title
    Percentage of Participants Who Experience Consecutive Elevations in AST ≥5 Times ULN
    Description
    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.
    Time Frame
    up to 12 weeks
    Title
    Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥5 Times ULN
    Description
    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.
    Time Frame
    up to 12 weeks
    Title
    Percentage of Participants Who Experience Consecutive Elevations in ALT ≥10 Times ULN
    Description
    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.
    Time Frame
    up to 12 weeks
    Title
    Percentage of Participants Who Experience Consecutive Elevations in AST ≥10 Times ULN
    Description
    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.
    Time Frame
    up to 12 weeks
    Title
    Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥10 Times ULN
    Description
    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.
    Time Frame
    up to 12 weeks
    Title
    Percentage of Participants With Potential Hy's Law Condition
    Description
    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.
    Time Frame
    up to 12 weeks
    Title
    Percentage of Participants Who Have Elevations in Creatine Kinase (CK) ≥10xULN
    Description
    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.
    Time Frame
    up to 12 weeks
    Title
    Percentage of Participants Who Have Elevations in CK ≥10xULN With Muscle Symptoms
    Description
    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.
    Time Frame
    up to 12 weeks
    Title
    Percentage of Participants Who Have Elevations in CK ≥10xULN and Drug-Related Muscle Symptoms
    Description
    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.
    Time Frame
    up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    Citation
    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
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