MULTICENTRIC DOUBLE BLIND RANDOMIZED PARALLEL STUDY CONTROLLED WITH PLACEBO AND ACTIVE COMPARATOR TO EVALUATE THE EFFECTIVENESS OF THE ALTERATION OF LIPIDS, SAFETY AND TOLERABILITY OF L-410198 IN PATIENTS WITH MIXED HYPERLIPIDEMIA (CHOLESTEROL AND ELEVATED TRIGLYCERIDES)

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2000年5月23日最近更新: 2023年9月4日

试验速览

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发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•Men and women (either postmenopausal or, in case of being premenopausal, surgically sterilized or using the contraceptive pill or having an IUD placed for more than 3 months). Postmenopausal means the absence of menstruation during the previous 18 months. If the cessation of menstruation is within 3 years, FSH should be elevated to the post-menopausal range in Visit 1, Day -28. All premenopausal women should have a negative 6-hCG test at Visit 3, Day 1.
•Age between 21 and 65 years old.
•Mixed hyperlipidemia defined as Total-C of> 190 mg / dL (4.81 mmol / L) (as an average of Visit 1, Day -28 and Visit 2, Day -7) and apo-B> 115 mg / dL in Visit 2, Day -7 and average TG of 250 to 700 mg / dL (from 2.82 to 7.90 mmol / L) of Visit 1, Day -28 and Visit 2, Day -7.
•Liver transaminase values (ALT or SGPT and AST or SGOT) <20% above ULN (ALT <30 mg / dL and AST <27 mg / dL) and CK <50% ULN (<180 mg / dL) at Visit 2, Day -7 unless there is an obvious aetiology for elevation.
•Consumption of alcohol <7 drinks per week

排除标准

•A diagnosis of type I, IV and V dyslipidemia or homozygous familial hypercholesterolemia.
•Hypercholesterolemia secondary to hypothyroidism [TSH> 10 pUI / mL, measured at Visit 1, Day -28 and Total T4 <4 micrograms / dL measured at Visit 1, Day -28 if TSH> 10 pUI / mL]. Patients with a history of hypothyroidism, which are in a stable dose of thyroxine with plasma thyroxine and normalized TSH, may be included.
•Secondary dyslipidemia due to nephrotic syndrome or HIV.
•Previous use of lipid alteration agents taken for 4 weeks, including agents that produce bile acid sequestration, HMG-CoA reductase inhibitors and nicotinic acid; or fibrates taken for 6 weeks; or probucol in a 1 year, prior to Visit 2, Day -7
•Documented coronary disease (ie, acute coronary syndrome, including unstable angina, Q-wave and Q-wave myocardial infarction, previous percutaneous transluminal coronary angioplasty or coronary bypass surgery) and patients with Class 2 cardiac status, 3 and 4 of the New York Heart Association (NYHA) and / or history of clinically significant peripheral edema in the past 6 months.
•Uncontrolled hypertension (treated or untreated) with systolic blood pressure typically> 160 mm Hg or diastolic> 95 mm Hg.
•Patients taking or using 1 or more of the following: warfarin or warfarin-type anticoagulants, digoxin, theophylline, anti-dysrhythmic or anticonvulsant medications; cyclosporin; itraconazole and systemic ketoconazole, erythromycin or clarithromycin, nefazodone, mibefradil and inhibitors of HIV proteases; St. John´s malt, grapefruit or grapefruit juice.
•Known hypersensitivity to fenofibrates, gemfibrozil, bezafibrate, troglitazone, pioglitazone or rosiglitazone.
•Renal impairment as measured by serum creatinine> 1.5 mg / dL (132.6 mmol / L).
•Active liver disease, including hepatitis A, B or C (as determined by positive IgM for Type A, positive for central antigen in Type B and positive for Type C antibodies) or biliary cirrhosis.
•History of pancreatitis.
•History of gallbladder disease including cholelithiasis.
•Patients with known diabetes mellitus Type 1 or 2 as confirmed by fasting plasma glucose> 140 mg / dL (7.8 mmol / L) or a treatment with antidiabetic medication.
•Partial ileal shunt.
•Patients whose weight is> 280 pounds or 50% below the ideal weight, according to the 1983 Metropolitan Height and Weight Insurance Tables
•Compliance with dose taking during the transition phase with placebo <75%.
•Surgery and / or treatment with any other investigational drug within 30 days prior to Visit 2, Day -7.
•History of anemia (defined as hemoglobin <10 g / dL) that requires specific treatment within 5 years of Visit 1 or a history of thrombocytopenia (defined as platelet count less than 100,000 / pL) within 5 years of Visit 1
•Patient with a history of neoplastic disease with the exception of: patients with adequately treated basal cell carcinoma or carcinoma in situ of the cervix. No exception will be applied.
•Any other condition or therapy that, in the opinion of the investigator, could represent a risk to the patient or confuse the results of the study.
•Bad mental function or any other reason to suppose some difficulty of the patient in fulfilling the requirements of the study.

研究者

发起方

MERCK SHARP & DOHME PERU S.R.L.,

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