MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, 12-WEEK FACTORIAL DISTRIBUTION STUDY TO ASSESS THE EFFECTIVENESS OF SCH 58235 10 MG / DAY COADMINISTERED WITH MULTIPLE DOSES OF SIMVASTATIN IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA.
- Conditions
- -E780 Pure hypercholesterolaemiaPure hypercholesterolaemiaE780
- Registration Number
- PER-024-01
- Lead Sponsor
- SCHERING PLOUGH RESEARCH INSTITUTE,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Patients with plasma LDL-C levels> 145 mg / dL, but <250 mg / dL (> 3.7 mmol / L and <6.4 mmol / L) obtained at Visit 2 (Week-1).
• Triglyceride level <350 mg / dL (3.96 mmoI / L).
• Men or women <80 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.
• Patients weighing less than 50% of the ideal body weight according to the Metropolitan Weight and Height Tables of 1983 or patients with <100 Ibs (45 kg)
• Hypersensitivity to HMG-CoA reductase inhibitors.
• Any other condition, situation or treatment that, in the opinion of the investigator, puts the patient at risk or interferes with their participation in the study.
• Patients with coronary heart disease who are receiving lipid-reducing treatment or patients with hypercholesterolemia in whom the suspension of lipid-lowering treatment for 4 months is inappropriate according to what the investigator determined.
• Treatment with any other investigational medication in the last 30 days.
• Pregnant or lactating women.
• Patients previously randomized in any study that evaluates SCH 58235. Concomitant diseases (Not allowed)
• Congestive heart failure class I or IV of the NYHA.
• Uncontrolled cardiac arrhythmias.
• Myocardial infarction, coronary bypass graft or anglopiasis in the 3 months prior to Visit 1.
• Severe or unstable peripheral artery disease in the 3 months prior to Visit 1.
• Patients with Type 2 Diabetes Mellitus with poor control (HbMc> 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method