None listed
Conditions
Interventions
Group 1 Type of group
SCH 58235 10 mg placebo
Group 10 Type of group
simvastatin 80 mg PO
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients with plasma LDL-C levels> 145 mg / dL, but 3.7 mmol / L and 18 years of age. • Premenopausal men or women surgically sterilized or women with very low chances of getting pregnant. [With low probability of pregnancy means women who use an acceptable contraceptive method (such as oral contraceptives, IUD, double barrier methods, hormonal implants, abstinence or partner with vasectomy). The researcher supports the inclusion of the patient in the study based on the current contraceptive method]. • Alcohol consumption of <14 drinks per week. • Liver transaminases (ALT and AST) <2 times the upper normal limit (LNS) without active liver disease and CK <1.5 times the LNS.
Exclusion criteria
Exclusion criteria: • Patients weighing less than 50% of the ideal body weight according to the Metropolitan Weight and Height Tables of 1983 or patients with 9.0%) or recently diagnosed (in the last 3 months) or in whom the antidiabetic pharmacotherapy has been changed [(for example: change in dose (except for ± 10 units of insulin) or a new medication has been added] in the 3 months prior to selection. • Patients with type 1 diabetes mellitus who are not under a stable insulin regimen for 3 months or with a recent history of repeated hypoglycaemia or unstable glycemic control. • Metabolic or uncontrolled endocrine disease that is known to influence lipoproteins or serum lipids (eg, secondary causes of hyperlipidemia). Clinically euthyroid patients with thyroid hormone replacement doses are eligible for inclusion if the TSH is within the normal range of selection by the central laboratory. • Impaired renal function (creatinine> 2.0 mg / dL), nephrotic syndrome or other kidney disease. • Patients known as HIV positive. • History of mental instability, alcoholism / drug addiction in the last 5 years or important psychiatric illness without adequate and stable control of treatment. • Uncontrolled hypertension (with or without treatment) with systolic blood pressure> 160 mm Hg or diastolic> 100 mm Hg in Week -4 (Visit 1). • Known coagulation abnormalities (for example, TP at Visit 1> 1.25 times the control). • Concomitant medications (Prohibited) • Patients with medications that are potent inhibitors of CYP3A4: these include cyclosporine; systemic keraconazole or ketoconazole; erythromycin or clarithromycin, nefazodone and protease inhibitors. • Lipid-lowering drugs, including bile acid sequestrants, HMG-CoA reductase inhibitors and niacin administered in the last 6 weeks and fibrates in the last 8 weeks, before randomization on Day 1 (Visit 3) (see treatment) concurrent, Section IE3.S. for information on other agents that alter lipids] or patients who are receiving LDL apheresis. • Oral steroids (unless corticosteroids are replacement therapy for the treatment of hypophyseal / suprarenal disease and have been treated with a stable regimen for at least 6 weeks before inclusion in the study). • Patients treated with verapamil. • Cardiovascular medications such as beta-blockers, calcium channel blockers, ACE inhibitors, nitrates or alpha-adrenergic bloc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Lipidic Profile Measure:Percentage change in the LDL-C with respect to the initial level based on the measurement of Week 12. Timepoints:Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Lipidic Profile Measure:Percentage of patients achieving target LDL-C levels in Week 12 Timepoints:Week 12 ; Outcome name:Lipidic Profile Measure:Percentage change in other lipid parameters from the initial value until Week 12. Timepoints:Week 12 ; Outcome name:Clinical evaluation, record of adverse events and laboratory tests. Measure:Safety and Tolerability Timepoints:When the event appears | — |
Outcome results
None listed