EUCTR2004-000882-36-FI进行中（未招募）不适用
A multi-centre, two-staged with interim analysis, parallel, randomised, double blind, placebo-controlled, dose ranging study of the safety, tolerability, and effects on plasma high-density lipoprotein cholesterol (HDLc) of 12 weeks treatment with 2.5mg, 5mg and 10 mg daily doses of GW501516 in subjects with low HDLc
GlaxoSmithKine Research & Development Limited0 个研究点目标入组 424 人开始时间: 2004年6月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 424
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. Male or female subjects aged 18 to 75 years.
- •2. Females must be of non-childbearing potential (surgically sterile or post-menopausal [amenorrhoeic] for more than one year).
- •3. Fasting plasma HDLc concentration less than or equal to 45mg/dL (less than or equal to 1.16mmol/L)
- •4. Subjects whose plasma LDLc concentration does not require treatment according to the NCEP/ATPIII guidelines:
- •? Plasma LDLc concentration less than or equal to 190mg/dL (less than or equal to 4.91mmol/L) if no more than one cardiovascular risk factor, or
- •? Plasma LDLc concentration less than or equal to 160mg/dL (less than or equal to 4.13mmol/L) if two or more cardiovascular risk factors, and a 10-year CHD risk less than or equal to 10% (Framingham Point Scores; see Section 14.8), or
- •? Plasma LDLc concentration less than or equal to 130mg/dL (less than or equal to 3.36mmol/L) if two or more cardiovascular risk factors, and a 10-year CHD risk >10% and less than or equal to 20% (Framingham Point Scores).
- •5. Fasting plasma TG concentration less than or equal to 500mg/dL (less than or equal to 5.65mmol/L).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. A medical history significant for the following:
- •? CHD, heart failure, stroke, peripheral vascular disease, angina pectoris or previous myocardial infarction) or a 10-year risk for developing CHD >20% (Framingham Point Scores).
- •? QTc interval >440msec (males) or >450msec (females) at screening.
- •? Known Type 1 or Type 2 diabetes mellitus or fasting plasma glucose (FPG) at screening AND at Visit 2 both >126mg/dL (>7mmol/L).
- •? History of renal disease or renal impairment or serum creatinine >1.5mg/dL (135micromol/L) at screening.
- •? History of metabolic acidosis or rhabdomyolysis, or a history of myalgia, myositis or myopathy after taking statins and/or fibrates, or CPK >3 x ULN at screening.
- •? Pre-existing gallbladder disease (unless the subject has since undergone a cholescystectomy).
- •? History of chronic pancreatitis.
- •? History of familial adenomatous polyposis or colonic polyps.
- •? History of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody), or other chronic hepatic disorders; or ALT or AST >2 x ULN, or alkaline phosphatase or total bilirubin >1.5 x ULN of laboratory reference range at screening.
- •? Inadequately treated thyroid dysfunction or an abnormal thyroid function test at screening.
- •2. Subjects who are taking or who have taken within eight weeks of screening any of the following drugs:
- •? Drugs for the treatment for dyslipidaemia
- •? Drugs known to have a substantial effect on lipid or lipoprotein metabolism,
- •? Anticoagulants or anti-platelet agents (other than low dose [75mg] aspirin).
- •3. Any change in concomitant medication that has a moderate effect on lipid or lipoprotein metabolism within eight weeks prior to screening.
- •4. Any major change in diet, exercise habits or smoking status within eight weeks prior to screening.
- •5. Use of an investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication
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