Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia/Mixed Dyslipidemia
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.; Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.
Intervention description: Tables containing: Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.; Tables containing: Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hypercholesterolemia; Dyslipidemia

Summary:

      The purpose of this study is to determine the non-inferiority between two different FDC
      (fixed-dose combination), measuring LDL-Cholesterol levels, in high risk patients with
      primary hypercholesterolemia or mixed dyslipidemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants aged 18 to 80 years;

          -  Participants diagnosed with primary hypercholesterolemia or mixed dyslipidemia;

          -  Participants must not have other clinically significant comorbidities that may
             interfere with study evaluations;

          -  Participants able to understand and adhere to the therapeutic scheme and to attend the
             study visits;

          -  Participants who agree to maintain a low cholesterol diet throughout the study;

          -  Participants who agree to discontinue previous medication for hypercholesterolemia
             treatment throughout the study;

          -  Participants with hypercholesterolemia or mixed dyslipidemia with the following
             laboratory test results on the baseline visit: LDL-C level >130 mg/dl if were
             receiving prior treatment with statins; or LDL-C level >100 mg/dl if were receiving
             prior treatment with first generation statins; or LDL ≥160 mg/dL and ≤220 mg/dL and
             triglycerides ≤350 mg/dL if were not in prior treatment with statins.

          -  Female participants in reproductive age with negative serum beta-hCG test result in
             the baseline visit who agree to use acceptable contraceptive methods (oral
             contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal
             implants, barrier methods, hormonal patch, tubal ligation or female participants who
             declare to perform non reproductive sexual practices); except surgically sterile (for
             example oophorectomy and hysterectomy), surgical sterilization or of the partner; or
             postmenopausal for at least one year;

          -  Participants with laboratorial test results after treatment with Simvastatin 20 mg for
             four weeks with LDL-C level ≥100 mg/dl.

        Exclusion Criteria:

          -  Heart failure class III or IV (NYHA- New York Heart Association);

          -  Blood dyscrasia;

          -  Unstable angina pectoris;

          -  Myocardial infarction in the last 3 months;

          -  Planning for CABG (coronary artery bypass graft), peripheral or carotid percutaneous
             intervention for the next 90 days;

          -  Renal insufficiency: estimated Glomerular Filtration Rate (GFR) < 30 ml/min/m2;

          -  History of alcoholism that, at the investigator's discretion, could compromise the
             drug treatment compliance;

          -  Participants with comorbidities that hinder the interpretation of results or
             contraindicate the lipid-lowering therapy [uncontrolled hypothyroidism
             (thyroid-stimulating hormone [TSH] > 8 mUI/mL); uncontrolled diabetes (Hemoglobin A1c
             [HbA1c] > 8%); active hepatic disease; antiretroviral therapy for HIV, neoplasm
             (except for adequately treated skin cancer within the past 5 years), concomitant
             immunosuppressive therapy (transplant receivers and rheumatic disease);

          -  Uncontrolled systemic arterial hypertension;

          -  Hypersensitivity to any component of the investigational product;

          -  Participant who has participated in clinical trial protocols in the last twelve (12)
             months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the
             investigator considers that there may be a direct benefit to the patient;

          -  Any observational finding (clinical/ physical evaluation), laboratory abnormality,
             disease or therapy that is interpreted by the investigator as a risk to the research
             participant's participation in the clinical trial;

          -  Aspartate transaminase (AST) or alanine aminotransferase (ALT) more than two times the
             normal upper limit of the central laboratory reference range after treatment with
             Simvastatin 20 mg for four weeks;

          -  Creatine phosphokinase (CPK) more than three times the normal upper limit of the
             central laboratory reference range after treatment with Simvastatin 20 mg for four
             weeks.