A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Ezetimibe 10 mg; Rosuvastatin 2.5 mg; Placebo for Ezetimibe; Placebo for Rosuvastatin
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 321.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety and tolerability of 2 dose levels of
      MK-0653H in Japanese participants. The primary hypotheses are that the administration of
      MK-0653H is safe and tolerable and that MK-0653H is superior to single entity of Ezetimibe
      and Rosuvastatin in percent reduction from baseline in low-density lipoprotein-cholesterol
      (LDL-C) after 12 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese

          -  Outpatient with hypercholesterolemia

          -  Female participant who is of reproductive potential has to 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

          -  Will maintain a stable diet that is consistent with the Japan Atherosclerosis Society
             Guideline 2012 (JAS 2012) for prevention of atherosclerotic cardiovascular diseases
             for the duration of the study

        Exclusion Criteria:

          -  Uncontrolled hypertension (treated or untreated)

          -  Uncontrolled type 1 or type 2 diabetes mellitus

          -  History of coronary artery disease (CAD), CAD-equivalent disease

          -  Familial hypercholesterolemia or has undergone LDL apheresis

          -  Uncontrolled endocrine or metabolic disease known to influence serum lipids or
             lipoproteins

          -  Has 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

          -  Currently following an excessive weight reduction diet

          -  Currently engages 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 Rosuvastatin

          -  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