CTRI/2009/091/000443已完成3 期
PL100601 : A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15,500
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
- •Inclusion Criteria:
- •Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
- •Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.
- •Chronic coronary heart disease
- •At least one of the following:
- •At least 60 years old
- •Diabetes requiring treatment with medication
- •Low HDL cholesterol (good cholesterol)
- •Currently smoke cigarettes or stopped smoking within the past 3 months
- •Diagnosed mild or moderate reduction in kidney function
- •Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral arterial disease.
排除标准
- •Exclusion Criteria:
- •Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.
- •Liver disease
- •Severe reduction in kidney function OR removal of a kidney OR kidney transplant
- •Severe heart failure
- •Blood pressure higher than normal despite lifestyle changes and treatment with medications
- •Any life-threatening disease expected to result in death within the next 2 years (other than heart disease)
- •Severe asthma that is poorly controlled with medication
- •Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)
- •Previous severe allergic response to food, drink, insect stings, etc.
- •Drug or alcohol abuse within the past 6 months OR mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.
- •Certain medications that may interfere with the study medication (these will be identified by the study doctor)
- •Participation in a study of an investigational medication within the past 30 days
- •Current participation in a study of an investigational device
研究者
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