A RANDOMIZED, DOUBLE BLIND, CONTROLLED, MULTIETHENIC STUDY OF PATIENTS WITH PRIMARY HYPERCOLESTEROLEMIA AND HIGH CARDIOVASCULAR RISK AND WITHOUT ADEQUATE CONTROL WITH ATORVASTATIN OF 20 MG: A COMPARISON OF CHANGE OF A COMBINED TABLET MGB / 40 MG ) AGAINST THE DUPLICATION OF THE BASE DOSE OF ATORVASTATIN OF 40 MG
- Conditions
- -I95-I99 Other and unspecified disorders of circulatory systemOther and unspecified disorders of circulatory systemI95I99
- Registration Number
- PER-135-08
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Men or women> 18 and <80 years old.
• Patients without prior treatment with statin and / or ezetimibe and whose LDL-C value prior to selection is within the range noted in Appendix 6.5. Without prior treatment, it is defined as not having been treated with a statin and / or ezetimibe during the last 6 weeks before the pre-selection visit.
• The patient is willing to maintain the Lifestyle Changes of ESC / NCEP (TLC) or similar cholesterol lowering diet throughout the study.
• A potentially fertile patient agrees to abstain or use (or have his partner use) 2 acceptable contraceptive methods for the duration of the study. Acceptable contraceptive methods are: intrauterine device (IUD), diaphragm with spermicide, condom, vasectomy and hormonal contraceptives.
• LDL-C level> 100 mg / dl (2.59 mmol / L) in Visit 2 (sample collected in Visit 1).
• The patient has liver transaminases (ALT and AST) <2.0 x ULN (sample collected at Visit 1) without active liver disease at Visit 2.
• The patient has creatine kinase levels (CK <3.0 x ULN (240 mU / mL) at Visit 2 (sample collected at Visit 1).
• The patient meets the criteria of discharge patient, risk of ATP 111 (with coronary heart disease (CMD) or equivalent risk of CHD or has + 2 multiple risk factors that confer a 10-year risk for CMD> 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).
• 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) <30 mL / min / 1.73 m2 based on the MDRD (Diet Modification in Kidney Disease) equation of 4 variables in Visit 1 (as performed by the Central Laboratory), nephrotic syndrome or other clinically significant kidney disease in Visit 1 (Week -6).
• The patient has an endocrine or metabolic uncontrolled disease that is known to influence serum lipids and lipoproteins (ie secondary causes of hyperlipidemia, for example hyper or hypothyroidism, Cushing´s syndrome) at Visit 1 (Week -6).
• Patient with poorly controlled type I or 2 diabetes mellitus (HbA1c> 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:All lipid determinations used in the analyzes will be those obtained through the central laboratory and will be expressed in international units.<br>Measure:Percent change from baseline in LDL-C<br>Timepoints:6 weeks<br>
- Secondary Outcome Measures
Name Time Method