EUCTR2012-000191-41-CZ进行中（未招募）不适用
A PHASE II, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF THE SAFETY AND EFFICACY OF MPSK3169A IN PATIENTS WITH CORONARY HEART DISEASE OR HIGH RISK OF CORONARY HEART DISEASE
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 224
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
- •At least one of the following:
- •- Coronary heart disease (CHD) with a history of myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or prior coronary angiography demonstrating coronary atherosclerosis
- •- A CHD risk–equivalent condition, including diabetes mellitus (type 1 or 2), chronic kidney disease, prior stroke, carotid disease, peripheral arterial disease, or abdominal aortic aneurism
- •- =2 CHD risk factors (age =45y for men or =55y for women; smoking; hypertension; low HDL cholesterol; family history of premature CHD) and a high risk of a CV event based on risk estimation systems
- •Use of a standard-of-care statin at a stable dose, or intolerance of statins, without use of other lipid modifying therapies
- •Fasting LDL cholesterol 90–250 mg/dL on the statin regimen above
- •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 134
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •Severe congestive heart failure (NYHA Class III-IV) or left ventricular ejection fraction = 35%
- •Recent (within 3 months) MI, unstable angina, stroke, transient ischemic attack, CABG, PCI, hospital admission for heart failure, major surgery, uncontrolled cardiac arrhythmia (other than atrial fibrillation or flutter), or initiation of renal replacement therapy (dialysis)
- •Fasting serum triglyceride level =400 mg/dL
- •Homozygous familial hypercholesterolemia
- •Poorly controlled diabetes mellitus, hypertension or thyroid disease
- •Liver or muscle disease, including abnormal test results at screening
- •Pregnant or lactating
- •The above list is not intended to contain all factors relevant to a patient’s eligibility for the study.
研究者
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