None listed
Conditions
Interventions
Washout phase: Patients will be given placebo medication for 6 weeks. They will be instructed to take at bedtime 1 tablet of each of two bottles delivered at the baseline visit.
Double-blind phase: a package consisting of two bottles (containing simvastatin 10mg or placebo) will be provide to each participant. Patients will be instructed to take one tablet of each bottle once a day at bedtime. In week 8 (Visit T6) the dose can be doubled based on the LDL values obtained during visit T6, and
Washout phase: Patients will be given placebo medication for 6 weeks. They will be instructed to take at bedtime 1 tablet of each of two bottles delivered at the baseline visit.
Double-blind phase: a package consisting of two bottles (containing atorvastatin 10mg or placebo) will be provide to each participant. Patients will be instructed to take one tablet of each bottle once a day at bedtime. In week 8 (Visit T6) the dose can be doubled based on the LDL values obtained during visit T6, and
Sponsors
PARKE DAVIS,
Eligibility
Inclusion criteria
Inclusion criteria: - LDL cholesterol value> 150mg/dL (>4.2mmol/L) and <250mg/dL (<6.5mml/L) in week -2 according to the Friedewald formula. - Serum triglycerides <400mg/dL (<4.5mmol/L) measured in week -2.
Exclusion criteria
Exclusion criteria: - Patients under 18 years old or over 80 years old. - Pregnant women or in nursing. - Patients consuming more than 14 alcoholic beverages per week (approximately 185g of pure alcohol). - Documented hepatic dysfunction, and SGOT (AST) or SGPT (ALT) values>1.5 times the upper limit of the normal range. - Secondary causes of hyperlipoproteinemia: uncontrolled primary hypothyroidism (TSH> 6.2UIU / mL), nephrotic syndrome, renal dysfunction, BUN> 30mg/dL (10.71mmol/L), creatinine>2.0mg/dL (176umol/L), uncontrolled noninsulin-dependent diabetes mellitus (HbA1c> 10%), diabetes mellitus type I, CPK>3 times the normal limit or unexplained CPK elevations. - Body Mass Index> 32. - Uncontrollable hypertension defined as a diastolic blood pressure >95mmHg after resting for a minimum of 3 minutes, whether or not taking antihypertensive medication. - Patients who may be unreliable as research participants because of alcohol abuse or unwillingness/desire to adhere to a low-lipid diet. - Patients who are participating in a concurrent clinical trial or who participated in a prior clinical trial 30 days before the enrollment in this study. - Patients with known hypersensitivity to HMG-CoA inhibitors. - Patients under medication excluded in Section 5.3. - Patients who have suffered a myocardial infarction, coronary artery bypass surgery, angina pectoris or severe or unstable coronary angioplasty within three months prior to enrollment. - Other conditions which according to investigator´s opinion may compromise the patient´s safety or their successful participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Change in LDL-C levels in comparison to the baseline level. The baseline level is the mean of LDL-C levels in the week -2 and week 0. Measure:Primary efficacy parameter Timepoints:Weeks -2,0,8 and 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Change in LDL-C levels in comparison to the baseline level. The baseline level is the mean of LDL-C levels in the week -2 and week 0. Measure:Primary efficacy parameter Timepoints:Weeks -2,0,8 and 16. ; Outcome name:Frequency and intensity of adverse events (clinical and laboratory). Measure:Safety parameters. Timepoints:Throughout the study. | — |
Countries
Chile, Colombia, Peru, Venezuela
Outcome results
None listed