NCT01609140已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 248
- 主要终点
- Absolute change from baseline in LDL-c concentration
研究概览
简要总结
The purpose of this study is to evaluate the safety and cholesterol lowering effects of MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a high risk of cardiovascular events and LDL-c levels well above goal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •And 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 >/= 45 years for men or >/= 55 years 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
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.
研究组 & 干预措施
F
Placebo Comparator
干预措施: Placebo (Drug)
A
Experimental
干预措施: MPSK3169A (Drug)
B
Experimental
干预措施: MPSK3169A (Drug)
C
Experimental
干预措施: MPSK3169A (Drug)
D
Experimental
干预措施: MPSK3169A (Drug)
E
Experimental
干预措施: MPSK3169A (Drug)
结局指标
主要结局
Absolute change from baseline in LDL-c concentration
时间窗: at Day 169
次要结局
- Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm(at Day 169 and over the 24 week treatment period)
- Percent and absolute change from baseline in total cholesterol, non-HDL-c, and apolipoprotein B (ApoB) at Day 169 and at the nadir for each arm(at Day 169 and over the 24 week treatment period)
- Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm(over the 24 week treatment period)
- Average value over time of the change in LDL-c (absolute and percent change) for each arm, up to Day 169, weighted by the number of weeks between consecutive LDL-c measurements(up to Day 169)
- Percent and absolute change from baseline in LDL-c concentration at all other designated timepoints(at all other designated timepoints)
研究者
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