A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384)
Condition: Hypercholesterolemia; Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: EZ 10 mg/Atorva 20 mg FDC; EZ 10 mg/Atorva 10 mg FDC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin
      (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants
      with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up
      to 20 mg. There is no formal hypothesis for the study.
    

Eligibility criteria:

        Inclusion Criteria

          -  Japanese

          -  Outpatient with hypercholesterolemia

          -  Has familial hypercholesterolemia (FH) diagnosed per genetic testing or meets two or
             more of the below criteria based on Japan Atherosclerosis Society Guideline 2012
             (JAS2012): Hyper low-density lipoprotein (LDL)-cholesterolemia (an untreated LDL-C
             level of ≥180mg/dL); tendon xanthoma (tendon xanthoma on the backs of the hands,
             elbows, knees, etc. or achilles tendon hypertrophy) or xanthoma tuberosum; family
             history of FH or premature coronary arterial disease (within the participant's second
             degree relatives)

          -  Females must be of 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 JAS 2012 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)

          -  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