A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg; Comparator: rosuvastatin 10 mg; Comparator: rosuvastatin 10 mg + ezetimibe 10 mg; Comparator: rosuvastatin 20 mg
Intervention description: Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.; Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.; Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.; Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
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: 440.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the
      addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in
      participants treated with rosuvastatin alone and not at their National Cholesterol Education
      Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is currently taking a stable dose of lipid lowering agent(s). (if
             applicable) or is statin naive

          -  Participant is currently taking a stable dose of lipid lowering agent(s). (if is at
             least moderate high risk for Coronary Heart Disease (CHD))

          -  Participant is currently taking a stable dose of lipid lowering agent(s). (if is
             willing to maintain Therapeutic Lifestyle Changes (TLC) / American Diabetes
             Association(ADA) diet)

        Exclusion Criteria:

          -  Participant weighs less than 100 lbs (45 kg).

          -  Participant has hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any
             components of these medications.

          -  If female, participant is pregnant or breastfeeding.

          -  Participant consumes more than 2 alcoholic beverages per day.

          -  Participant has been in a clinical trial within the last 30 days.

          -  Participant has heart problems such as CHF, unstable angina or heart attack.

          -  Participant has type 1 or 2 diabetes and has changed their medication in the last 2
             months.

          -  Participant has liver disease.

          -  Participant is Human Immunodeficiency Virus (HIV) positive.

          -  Participant has a history of drug or alcohol abuse in the last year.