None listed
Conditions
Interventions
Group 1 Type of group
ezetimibe / simvastatin (10 ing / 40 mg) orally every night, for 10-12 weeks
Group name:Group 2 Type of group
40 mg atorvastatin orally every night for 10-12 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Men or women> 18 and 100 mg / dl (2.59 mmol / L) in Visit 2 (sample collected in Visit 1). • The patient has liver transaminases (ALT and AST) 20% as determined by the calculation of Eramingham) (lipid values ​​obtained in Visit 1) • The patient has completed the 4 or 6 week selection / stabilization period by taking atorvastatin 20 mg. • LDL-C level> 100 mg / dl (2.59 mmoI / L) and <160 mg / dL (4.14 mmol / L) at Visit 4 (sample collected at Visit 3). • The patient has triglyceride (TG) concentrations <350 mg / dL (3.96 mmoI / L) at Visit 4 (sample collected at Visit 3).
Exclusion criteria
Exclusion criteria: • The patient has hypersensitivity or intolerance to ezetimibe, simvastatin or atorvastatin or any component of these drugs or has a history of significant myopathy or rhabdomyolysis with ezetimibe or any statin. • The patient routinely consumes more than 2 alcoholic beverages per day (average> 14 alcoholic beverages per week). • The female patient is pregnant or breastfeeding. • The patient has been treated with another investigational drug within 30 days of Visit 1 (Week-6). • The patient has a condition or situation that, in the opinion of the researcher, could represent a risk to the patient or interfere with participation in the study. • The patient is currently taking a stable dose of a staline listed below: Simvastatin 80 mg, Atorvastatin 40, 80 mg, Rosuvastatin 10, 20.40 mg, • The patient has congestive heart failure defined by NYMA Class III or IV (New York Meart Association). • The patient has had a myocardial infarction, coronary artery bypass surgery or angioplasty within 3 months prior to Visit 1. • The patient has uncontrolled cardiac arrhythmias or recent significant changes in the patient´s electrocardiogram (ECG). • The patient has undergone partial iliac bypass, gastric bypass or other procedure due to major intestinal malabsorption. • The patient has uncontrolled hypertension (treated or untreated) with systolic blood pressure> 160 mmHg or diastolic> 100 mg Hg at Visit 1 (Week -6). Researchers are encouraged to maximize blood pressure control according to current guidelines. • The patient has an estimated glomerular filtration rate (eGIlF) 8.5%) or recently diagnosed (within 3 months) or any change in antidiabetic pharmacotherapy [ie, dosage changes (with the exception of ± 10 units of insulin ) or the addition of a new drug] within 3 months prior to selection or patients experiencing a recent history of repeated hypoglycemia or unstable glycemic control. • The patient has disorders of the hematological, digestive or central nervous systems including cerebrovascular and degenerative disease that could limit the evaluation or participation in the study. • A patient known to be HIV positive (based on medical history evaluation). • The patient has a history of malignancy <5 years before signing the informed consent, except for basal cell skin cancer or properly treated squamous cells or cervical cancer in situ (melanoma, leukemia, lymphoma and myeloproliferative disorders are excluded of any duration). • The patient has a history of mental instability, drug / alcohol abuse within the last 5 years or an important psychiatric illness that is poorly controlled and stable with pharmacotherapy. • The patient is currently taking drugs that are potent inhibitors of cytochrome P450 3A4 (CYP3A4) including systemic inlraconazole or ketoconazole or fluconazole, erythromycin or clarithromycin or telithromycin, n
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:All lipid determinations used in the analyzes will be those obtained through the central laboratory and will be expressed in international units. Measure:Percent change from baseline in LDL-C Timepoints:6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:All lipid determinations used in the analyzes will be those obtained through the central laboratory and will be expressed in international units. Measure:Percentages of patients reaching the target level of LDL-C <70 mg / dL (1.81 mmol / L) Timepoints:6 weeks ; Outcome name:All lipid determinations used in the analyzes will be those obtained through the central laboratory and will be expressed in international units. Measure:percentages of patients reaching the target level of LDL-C <77 mg / dL (2.00 mmol / L) Timepoints:6 weeks ; Outcome name:All lipid determinations used in the analyzes will be those obtained through the central laboratory and will be expressed in international units. Measure:percentages of patients reaching the target level of LDL-C <100 mg / dL (2.59 mmoI / L). Timepoints:6 weeks ; Outcome name:All lipid determinations used in the analyzes will be those obtained through the central laboratory and will be expressed in international units. Measure:Percentage change from baseline to end point in total cholesterol (TC), triglycerides (TG), high density lipoprotein cholesterol (HDL-C), non HDL-C, LDL-C / HDLC ratio, TC ratio / HDL-C, non-L-IDL-C / HDL-C ratio, apoliprotein (Apo) B, Apo AI, Apo B / Apo AI ratio, and hs-CRP Timepoints:6 weeks | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed