EUCTR2005-001558-26-LV
进行中（未招募）
不适用
A RANDOMISED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED, MULTICENTRE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF ORAL GW677954 CAPSULES 2.5mg, 5mg, 10mg AND 20mg A DAY FOR 24 WEEKS IN OVERWEIGHT DYSLIPIDAEMIC SUBJECTS
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- GlaxoSmithKline
- 入组人数
- 290
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Waist circumference \=102cm (men) or \=88cm (women) at visit 1
- •2\. Fasting plasma HDL\-C \=40mg/dL (1\.03mmol/L) (men) or \=50mg/dL (1\.29mmol/L)
- •(women) at Screening Visit 1
- •3\. Fasting TGs \=150mg/dL (1\.69mmol/L) and \=800mg/dL (8\.96mmol/L) at Screening
- •4\. Subjects whose plasma LDL\-C concentration does not require treatment according to the NCEP ATP III guidelines at Screening Visit 1
- •Plasma LDL\-C concentration \=190mg/dL (\=4\.91mmol/L) if no more than one
- •cardiovascular risk factor, or
- •Plasma LDL\-C concentration \=160mg/dL (\=4\.13mmol/L) if two or more
- •cardiovascular risk factors, and a 10\-year congestive heart failure (CHF) risk
- •\=10% (Framingham Point Scores), or
排除标准
- •1\. Metabolic Disease including:
- •Diagnosis of Type 1 or Type 2 diabetes mellitus, or FPG at Screening, and at Visit 2 both \>126mg/dL (\>7\.0mmol/L);
- •Uncorrected thyroid dysfunction;
- •Significant weight gain or loss within the 3 months prior to Screening (Visit 1\).
- •2\. History of recent clinically significant cardiovascular disease at Visit 2 including:
- •History or ECG evidence of prior myocardial infarction
- •Current unstable angina or history of unstable angina
- •Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery that is either planned or occurred in the 6 months prior to Screening.
- •Clinically significant arrhythmia or valvular heart disease.
- •Congestive heart failure with NYHA Class II\-IV symptoms.
结局指标
主要结局
未指定
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