MULTICENTRIC DOUBLE-BLIND RANDOMIZED PARALLEL GROUPS CONTROLLED WITH PLACEBO STUDY WHOSE PURPOSE IS TO EVALUATE THE EFFECTIVENESS SAFETY AND TOLERABILITY OF F-1394 IN COMBINATION WITH THE REDUCTASE INHIBITOR HMG-COA SIMVASTATIN IN THE ALTERATION OF LIPIDS

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人2000年10月16日

概览

阶段: 未知
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: MERCK SHARP & DOHME PERU S.R.L.,
状态: 已完成
最后更新: 2年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2000年10月16日

结束日期

待定

最后更新

2年前

研究类型

Interventional

研究者

发起方

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

入排标准

入选标准

•Men and women (postmenopause). Postmenopause is defined as the absence of menstruation during the previous 18 months. If cessation of menstruation is within the last 3 years, FSH should be raised in the postmenopausal range at Visit 1, Day\-28\.
•Age from 21 to 65 years old.
•Primary hyperlipidemia defined as 100 mg / dL • Values of hepatic transaminases (ALT or SOFT and AST or SGOT) \<20% above upper limit of normal (ULN) (ALT \<30 mg / dL and AST \<27 mg / dL), and CK \<50% above of LSN (\<180 mg / dL) at Visit 2, Day \-7 unless there is an obvious aetiology for elevation.
•Alcohol consumption of \<4 drinks per day or \<14 drinks per week in total.

排除标准

•Diagnosis of type I, IV and V dyslipidemia or homozygous familial hypercholesterolemia.
•Hypercholesterolemia secondary to hypothyroidism \[TSH\> 100 uIU / mL, measured at Visit 1, Day \-28 and total T4 \<4 micrograms / dL measured at Visit 1, Day \-28 if the TSH is\> 10 p.lU/ mL]. Patients with a history of hypothyroidism, who are given a stable dose of thyroxine with TSH and normalized plasma thyroxine, may be included.
•Dyslipidemia secondary to nephrotic syndrome or HIV.
•Use of lipid\-altering agents in the 2 weeks prior to Visit 1, Day \-28, including bile acid and nicotinic acid sequestrants; or fibrates taken in the last 4 weeks; or probucol in the last year, before Visit 2, Day \-7\. If a patient is currently treated with a HMG\-CoA reductase inhibitor including dose of\> 40 mg / day of simvastatin, dose\> 40 mg / day of atorvastatin or 80 mg / day of lovastatin and pravastatin, he should be excluded from the study.
•Documented coronary artery disease (ie, acute coronary syndrome, including unstable angina, Q\-wave myocardial infarction or non\-Q wave, previous percutaneous transluminal coronary angioplasty, or coronary bypass surgery) or cerebrovascular disease (ie, stroke) within the last 6 months.
•Uncontrolled hypertension (treated or untreated) with systolic blood pressure typical of\> 160 mm Hg or diastolic\> 95 mm Hg.
•Patients taking or using one or more of the following: warfarin anticoagulants or warfarin\-like, digoxin, theophylline, anti\-dysrhythmic or anticonvulsant medications; cyclosporin; systemic itraconazole and ketoconazole, erythromycin or clarithromycin, nefazodone, mibefradil and HIV protease inhibitors; St. John´s wart, grapefruit or grapefruit juice, oral contraceptives.
•Known hypersensitivity to a reductase inhibitor HMG\-CoA or ACAT.
•Renal insufficiency according to the serum creatinine measurement of\> 1\.5 mg / dL (132\.6 mmol / L).
•Active liver disease or biliary cirrhosis.

结局指标

主要结局

未指定

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