Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia/Mixed Dyslipidemia

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 mayinterfere with study evaluations;

• Participants able to understand and adhere to the therapeutic scheme and to attend thestudy visits;

• Participants who agree to maintain a low cholesterol diet throughout the study;

• Participants who agree to discontinue previous medication for hypercholesterolemiatreatment throughout the study;

• Participants with hypercholesterolemia or mixed dyslipidemia with the followinglaboratory test results on the baseline visit: LDL-C level >130 mg/dl if werereceiving prior treatment with statins; or LDL-C level >100 mg/dl if were receivingprior treatment with first generation statins; or LDL ≥160 mg/dL and ≤220 mg/dL andtriglycerides ≤350 mg/dL if were not in prior treatment with statins.

• Female participants in reproductive age with negative serum beta-hCG test result inthe baseline visit who agree to use acceptable contraceptive methods (oralcontraceptives, injectable contraceptives, intrauterine device (IUD), hormonalimplants, barrier methods, hormonal patch, tubal ligation or female participants whodeclare to perform non reproductive sexual practices); except surgically sterile (forexample oophorectomy and hysterectomy), surgical sterilization or of the partner; orpostmenopausal for at least one year;

• Participants with laboratorial test results after treatment with Simvastatin 20 mg forfour 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 percutaneousintervention 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 thedrug treatment compliance;

• Participants with comorbidities that hinder the interpretation of results orcontraindicate 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), concomitantimmunosuppressive 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 theinvestigator 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 researchparticipant's participation in the clinical trial;

• Aspartate transaminase (AST) or alanine aminotransferase (ALT) more than two times thenormal upper limit of the central laboratory reference range after treatment withSimvastatin 20 mg for four weeks;

• Creatine phosphokinase (CPK) more than three times the normal upper limit of thecentral laboratory reference range after treatment with Simvastatin 20 mg for fourweeks.