A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, STUDY OF 12 WEEKS OF DURATION TO EVALUATE THE EFFICACY AND SAFETY OF MK-0524B (IN CODMINISTRATION OF DOSES OF MK-0524A AND SIMVASTATIN TABLETS) AGAINST ATORVASTATIN IN PATIENTS WITH HYPERLIPIDEMIA MIXED

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 9 人开始时间: 2008年12月31日最近更新: 2023年9月4日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 9

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

年龄范围: 18 至 80（—）

入选标准

•The patient is male or female> 18 and <80 years old on the day they sign the informed consent.
•Contraceptive methods for potentially fertile female patients: a potentially fertile patient agrees to abstain or use (or have her partner use) 2 acceptable methods of birth control during the course of the study. An acceptable method of birth control is defined as: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
•The patient meets the criteria based on the NCEP ATP III rating of the CHD risk) in Visit 2
•Concentrations of triglycerides (TG)> 150 mg / dL to <500 mg / dL (1.7 - 5.6 mmol / L) at Visit 2.

排除标准

•The patient is pregnant or breastfeeding, or expecting to conceive during the study, including the 14-day follow-up period after the study.
•The patient has a history of malignancy <5 years before signing the informed consent, except for basal cell cancer or squamous cell skin cancer or cervical cancer in situ adequately treated.
•The patient is waiting to donate eggs during the study, including the 14-day follow-up period.
•The patient has a history or concurrent evidence of any condition, therapy, or abnormality of laboratory tests that could confuse the results of the study, interfere with the patient´s participation during the entire course of the study, or not be the most convenient for the patient participates.
•It is unlikely that the patient sticks to the study procedures, respects appointments or is planning to move during the study.
•The patient is currently participating or has participated in a study
•The patient has donated and / or received blood as follows: donated blood products or had a phlebotomy of> 300 mL within 8 weeks prior to signing the informed consent, intended to give or receive blood products during the study, aims to donate more than 250 mL of blood products within 8 weeks after the last study visit.
•The patient has the following laboratory values excluding in Visit 1: Creatinine> 2.0 mg / dL (177 micromol / L), ALT (SGPT)> 1.5xULN, AST (SG0T)> 1.5xULN, CK> 2xULN, abnormal TSH
•The patient has Type 1 or Type 2 diabetes mellitus
•The patient is, at the time of signing the informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse.
•The patient is currently involved, or plans to be involved during the study, in vigorous exercise or an aggressive diet regimen. (See Appendix 6 and Section I.E.4.e) for guidelines and recommendations regarding exercise and diet).
•The patient met <80% with the dose during the placebo transition period AND, in the opinion of the investigator, is believed to be unable to maintain at least 80% compliance with the dose during the active period of administration of the drug. study dose.
•The patient suffers from an uncontrolled endocrine or metabolic disease known to influence lipids or serum lipoproteins (ie, secondary causes of hyperlipidemia, such as hypothyroidism or hyperthyroidism).
•The patient has a nephrotic syndrome or other clinically significant kidney disease.
•The patient suffers from chronic heart failure defined according to Classes III or IV of the New York Cardiology Association (NYHA).
•The patient has suffered from active peptic ulcer within 3 months of Visit 1.
•The patient has had a gout episode within 1 year prior to Visit 1, unless the patient is receiving allopurinol.
•The patient has a history of hypersensitivity or allergic reaction to niacin or to products containing niacin, simvastatin or atorvastatin.
•The patient suffers from uncontrolled / unstable cardiac arrhythmias.
•The patient has a history of myocardial infarction, stroke, coronary bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of Visit 1.
•The patient suffers from unstable hypertension (systolic blood pressure in sitting position> 160 mm Hg or diastolic pressure> 100 mm Hg) at Visit 1. Researchers are encouraged to maximize control of blood pressure in

研究者

发起方

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

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