PER-081-05已完成未知
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, FACTORIAL DESIGN STUDY TO EVALUATE THE EFFICACY OF ALTERATION OF THE LIPIDS AND SECURITY OF THE COMBINED TABLE OF MK-0524B IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED HYPERLIMIDEMIA
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2006年3月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- •a) The patient is male or female> 18 and <85 years old.
- •b) 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.
- •c) The patient has a history of primary hypercholesterolemia or mixed hyperlipidemia.
- •d) The patient has TG <350 mg / dL (3.95 mmol / L) at Visit 2.
排除标准
- •a) The patient is pregnant or breastfeeding, or waiting to conceive during the study.
- •b) The patient has a history of malignancy <5 years before signing the informed consent.
- •c) The patient is waiting to donate eggs during the study.
- •d) 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 participation of the patient during the entire course of the study, or not be the most convenient for that the patient participates.
- •e) It is unlikely that the patient sticks to the study procedures.
- •f) The patient is currently participating or has participated in a study with a compound under investigation within 30 days of Visit 1.
- •g) The patient has recently donated and / or received blood.
- •h) The patient has the following laboratory values excluding: 1. Creatinine> 2.0 mg / dL (177 micromol / L), 2) ALT (SGPT)> 1.5 X ULN, 3) AST (SGOT)> 1.5xULN, 4) CK> 2 X ULN
- •i) The patient is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse.
- •j) The patient has a condition or situation that, in the opinion of the investigator, may put the patient at risk, confuse the results or interfere with their participation in the study.
- •k) The patient is currently dedicated, or plans to dedicate himself during the study, to perform visorose exercise or to an aggressive diet.
- •l) The patient met in <80% with the dose during the transition period with placebo and is believed to be unable to maintain the
- •less 80% compliance with the dose during the active period of dose administration of the study.
- •m) The patient is in a high risk category according to the NCEP ATP III guidelines.
- •n) The patient suffers from an uncontrolled endocrine or metabolic disease.
- •o) The patient suffers from nephrotic syndrome or other clinically significant kidney disease.
- •p) The patient suffers from chronic heart failure.
- •q) The patient has suffered from active peptic ulcer within 3 months of Visit 3.
- •r) The patient has had a gout episode within the first year of Visit 1.
- •s) The patient has a history of hypersensitivity to niacin BR, products that contain niacin BR or simvastatin.
- •t) The patient suffers from uncontrolled / unstable cardiac arrhythmias.
- •u) The patient has a history of cerebrovascular accident within 3 months of Visit 1.
- •v) The patient suffers from uncontrolled hypertension.
- •w) The patient has a history of ileal bypass, gastric bypass or other significant condition associated with malabsorption.
- •x) The patient has active or chronic hepatobiliary or hepatic disease.
- •y) The patient is HIV positive.
- •z) The patient has been in treatment with orlistat, sibutramine or another anti-obesity drug <3 months before Visit 2.
- •aa) The patient has initiated therapy with lipid modifying agents.
- •bb) The patient is currently taking niacin> 50 mg / day.
- •cc) The patient is currently taking a fibrate.
- •dd) The patient is taking coumarins.
- •ee) The patient is receiving treatment with systemic corticosteroids or systemic anabolic agents.
- •ff) Drugs that are potent inhibitors of CYP3A4.
- •gg) Drugs that increase the risk of myopathy will also be banned.
- •hh) The patient ingests more than 2 alcoholic beverages per day.
- •ii) The patient is a woman who is currently taking hormonal contraceptives or usi
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