None listed
Conditions
Interventions
Wash-out therapy: 8 weeks before, patients must stop all therapies for lipid reduction until the time of randomization (Week 1).
Atorvastatin 20 mg will be administered orally as a tablet. Each patient will take a tablet every night for 12 weeks. Each patient will be provided with a vial of study medication during Weeks 1 and 6.
Group name:Study group Type of group
Wash-out therapy: 8 weeks before, patients must stop all therapies for lipid reduction until the time of randomization (Week 1).
Simvastatin 80 mg will be administered orally as a tablet. Each patient will take a tablet every night for 12 weeks. Each patient will be provided with a vial of study medication during Weeks 1 and 6.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a. Coronary heart disease (CHD) and/or atherosclerotic disease (AD) with LDL>130 mg/dL (>3.4 mmol/L); or >2 risk factors for CHD without CHD and/or AD but LDL>160 mg/dL (>4.16 mmol/L); or without CHD and/or AD and 190mg/dL (>4.9 mmol/L) at Visit 2 (Week -1). b. Triglycerides >350mg/dL (>3.95 mmol/L) at Visit 2 (Week -1). c. Liver transaminases (ALT, AST) with values not exceeding 10% of the normal upper limit (NUL) or CK values not exceeding 50% of the NUL without an obvious etiology in Visit 2 (Week -1). d. Ages 21 to 70. e. Alcohol consumption 3 months without complaint.
Exclusion criteria
Exclusion criteria: a. Type I, III, IV or V hyperlipidemia or familial hypercholesterolemia. b. Treatment for lipid reduction including bile acid chelators, HMG-CoA reductase inhibitors and nicotinic acid (6 prior weeks) and fibrates (8 prior weeks), or probucol in a year period before selection (Visit 1, Week -4). c. Any systemic immunosuppressant medication including cyclosporine; systemic azole antifungal agent including itraconazole and ketoconazole; erythromycin or clarithromycin; cisapride; H-1 blockers, terfenadine, astemizole, and nefazodone. d. Therapy with warfarin or anticoagulants similar to warfarin. e. Renal impairment defined by serum creatinine>1.8 mg/dL (>179pmol/L). f. Active liver disease. g. Acute coronary insufficiency (e.g., unstable angina or an intermediate syndrome); vasospastic angina (Prinzmetal). h. Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary pacemaker surgery or infarction in the previous three months. i. Uncontrolled hypertension (treated or not) with systolic blood pressure >160mmHg or diastolic >100 Hg. j. Secondary hypercholesterolemia to hypothyroidism (T4 10ug/mL, measured at Visit 1, Week -4) or nephrotic syndrome. k. Patients with Type 1 or Type 2 diabetes mellitus with HbA1c> 10% at Visit 1, Week -4. I. Partial ileal anastomosis. m. Weight 50% above the ideal body weight, according to the Metropolitan Tables of Weights and Heights of 1983. n. Hypersensitivity to HMG-CoA reductase inhibitors. o. Any other condition or therapy that, in the opinion of the investigator, may constitute a risk to the patient or may alter the results of the study. p. Poor mental functions or any other reason for which the patient is believed to have problems to provide informed consent or to comply with the requirements demanded by the study. q. Treatment with any other investigational medication within 30 days before the baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Relative potency of a diet plan and simvastatin of 40-80 mg/day or atorvastatin 20-40 mg/day in the LDL and triglycerides levels. Measure:Primary efficacy parameter Timepoints:Weeks -2, -1, 1, and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Relative potency of a diet plan and simvastatin of 40-80 mg/day or atorvastatin 20-40 mg/day in the triglycerides levels. Measure:Secondary efficacy parameter Timepoints:Weeks -2, -1, 1, and 12. ; Outcome name:Relative potency of a diet plan and simvastatin of 40-80 mg/day or atorvastatin 20-40 mg/day in the HDL and VLDL levels. Measure:Secondary efficacy parameter Timepoints:Weeks -2, -1, 1, and 12. ; Outcome name:Frequency and intensity of adverse events (clinical and laboratory). Measure:Secondary safety parameter Timepoints:Throughout the study. | — |
Countries
Chile, Colombia, Peru, Venezuela
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed