None listed
Conditions
Interventions
Simvastatin Type of group
The active treatment will be open. At the end of the diet period (Visit 2), patients who meet the lipid value criteria for active treatment will be titrated with 20 mg simvastatin for 6 weeks. At the end of the 6-week period, patients with a LDL-C> 100 mg / dL will be entitled to simvastatin 40 mg. Patients with LDL-C 100 mg / Dl will be titrated to 80 mg of simvastatin. Patients who have reached an LDL-C of
Sponsors
MERCK SHARP & DOHME PERÚ S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: A total of 150 patients will be recruited between the ages of legal consent and 70 years of age for this study. Patients must suffer from coronary heart disease (CHD). For the purposes of this study, CHD will include one or more of the following characteristics: documented stable angina (with evidence of ischemia in the stress test): history of myocardial infarction; history of coronary percutaneous intervention (mainly PTCA with or without stent placement); Symptomatic peripheral vascular disease (claudication); documented history of atherothrombotic cerebrovascular disease; and / or documented history of unstable angina or myocardial infarction without Q wave. Patients with acute coronary insufficiency are excluded from the study, as are patients who have experienced a myocardial infarction or have had a PCI or GABG within 3 months previous In week 1, while on the diet, all patients will require a CT <240 mg / dL, LDL-C between 115 and 180 mg / dL. In addition, patients will have triglycerides <400 mg / dL in this week 1. Patients should also understand the study procedures, should be informed of potential alternative treatments and should be willing to receive daily treatment with oral simvastatin 20, 40 or 80 mg for a period of 14 weeks.
Exclusion criteria
Exclusion criteria: • Premenopausal women, unless they are surgically sterilized or highly unlikely to conceive (eg, take oral contraceptives or have an IUD placed for 3 months). • Age over 70 or under 21 • Consumption of alcohol greater than 10 drinks per week • d. A diagnosis of hyperlipidemia type I, 11, III or V, or homozygous family hypercholesterolemia • Lipid reducing agents such as bile acid sequestrants, inhibitors of HIVlG-GoA reductase and nicotinic acid taken within the previous 6 months, fibrates taken within the previous 8 weeks, and probucol within one year prior to week 1 . • Patients receiving ciclosporin, or systemic antifungal agents of the azole type, including itraconazole and ketoconazole; erythromycin or clarithromycin; nefazodone; protease inhibitors; chronic systemic glucocorticoid therapy. • g. Renal insufficiency, determined by a serum creatinine> 179 mMol / L (1.8 mg / dL). • Elevations of transaminases 20% above normal upper limits (ÜLN) or active liver disease, or 100% GK above ÜLN without obvious etiology • Acute coronary insufficiency (eg, unstable angina or vasospastic angina [Prinzmetal]). • Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary bypass surgery within the previous 3 months. • Uncontrolled hypertension (treated or not), with systolic blood pressure> 160 mm Hg or diastolic> 100 mm Hg. • Secondary hypercholesterolemia due to hypothyroidism, nephrotic syndrome, or any other cause. (Patients with a history of hypothyroidism, who are on a stable dose of thyroxine, with normal plasma thyroxine and TSH may be included). • Patients with known type I diabetes mellitus, and with type 2 with HbAlc> 9%. • Partial ileal shunt. • Patients whose weight is> 50% above the ideal body weight according to the Weight and Size Tables • Hypersensitivity to inhibitors of HMG-CoA reductase. • Any other condition or therapy that, in the opinion of the investigator, may represent a risk to the patient or may confuse the results of the study. • Poor mental function or any other reason that anticipates the patient´s difficulty in granting informed consent or in order to comply with the requirements of the study. • Treatment with any other investigational drug within 30 days before the baseline. • Patients receiving anticoagulants other than aspirin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The efficacy of simvastatin will be evaluated by comparing the percentage changes from baseline to total cholesterol (TC), LDL-G, HDL-G, apolipoproteins B and AI, LDL-G / HDL-G ratio, cholesterol / HDL-G ratio and triglycerides Measure:Simvastatin Efficacy Timepoints:After the treatment has been administered | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Safety will be assessed through clinical evaluation, including physical examination, EGG, and safety laboratory tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatine kinase (GK). Clinical and laboratory safety evaluations will be conducted continuously during the study, and include: serious adverse events that will be reported immediately to the monitor, clinical withdrawals and laboratory tests (reported to the Clinical Monitor). Measure:Safety Timepoints:The duration of treatment | — |
Contacts
Public ContactStela López
MERCK SHARP & DOHME PERÚ S.R.L
Outcome results
None listed