EUCTR2011-003827-37-BE进行中（未招募）1 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study toEvaluate Long-term Tolerability and Durable Efficacy of AMG 145 on LDL-C in Hyperlipidemic Subjects - DESCARTES, Durable Effect of PCSK9 antibody CompARed wiTh placEbo Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 900
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
- •- Subject has provided informed consent.
- •- Male or female = 18 to = 75 years of age at screening.
- •- Fasting LDL-C = 75 mg/dL as determined by central laboratory at the initial screening visit
- •- Fasting LDL-C as determined by central laboratory at the end of the lipid stabilization period = 75 mg/dL (2.0 mmol/L) and meeting the following LDL-C values based on risk factor status (NCEP ATPIII risk categories Grundy et al, 2004):
- •< 100 mg/dL (2.6 mmol/L) for subjects with diagnosed CHD or CHD risk equivalent (includes clinical manifestations of noncoronary forms of atherosclerotic disease [peripheral arterial disease, abdominal aortic aneurysm, and carotid artery disease], diabetes, and 2+ risk factors with 10-year risk for hard CHD >20%). Risk factors include cigarette smoking, hypertension (BP = 140/90 mm Hg or on antihypertensive medication), low HDL cholesterol (< 40 mg/dL), family history of premature CHD (CHD in male first-degree relative < 55 years of age; CHD in female first-degree relative < 65 years of age), and age (men = 45 years; women = 55 years).
- •< 130 mg/dL (3.4 mmol/L) for subjects without diagnosed CHD or CHD risk equivalent
- •OR for subjects on maximal background lipid-lowering therapy (defined as atorvastatin 80 mg PO QD and ezetimibe 10 mg PO QD), LDL-C at the end of the lipid stabilization period of =75 mg/dL (2.0 mmol/L)
- •- Fasting triglycerides = 400 mg/dL (4.5 mmol/L) by central laboratory at screening and at end of lipid stabilization period
- •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 540
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 360
排除标准
- •- Diagnosed with CHD or CHD risk equivalent and not receiving statin therapy, with LDL-C at screening = 99 mg/dL
- •- NYHA II, III or IV heart failure, or last known left ventricular ejection fraction < 30%
- •- Uncontrolled cardiac arrhythmia defined as recurrent and highly
- •symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to randomization
- •- Myocardial infarction, unstable angina, percutaneous coronary
- •intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
- •- Planned cardiac surgery or revascularization
- •- Type 1 diabetes or newly diagnosed type 2 diabetes (within 6 months of randomization or new screening fasting plasma glucose = 126 mg/dL [7.0 mmol/L] or HbA1c = 6.5%), or
- •- Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg, confirmed with repeat measurement
- •- Subject has taken in the last 6 weeks prior to LDL-C screening red yeast rice, > 200 mg/day niacin, or >1000 mg/day omega-3 fatty acids (eg, DHA and EPA) or prescription lipid-regulating drugs other than statins or ezetimibe, such as fibrates and derivatives, or bile-acid sequestering resins
- •-Treatment in the last 3 months prior to LDL-C screening with any of the
- •following drugs: systemic cyclosporine, systemic steroids (eg IV,
- •intramuscular [IM], or PO) (Note: hormone replacement therapy is
- •permitted), vitamin A derivatives and retinol derivatives for the
- •treatment of dermatologic conditions (eg, Accutane); (Note: vitamin A in
- •a multivitamin preparation is permitted) Hyperthyroidism or
- •hypothyroidism as defined by thyroid stimulating hormone TSH below
- •the lower limit of normal (LLN) or > 1.5 times the upper limit of normal
- •(ULN), respectively, at screening
- •- Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at screening, confirmed by a repeat measurement at least 1 week apart
- •- Active liver disease or hepatic dysfunction, defined as aspartate
- •aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the ULN as determined by central laboratory analysis at screening or at end of lipid stabilization period, confirmed by a CK > 3 times the ULN at screening or at end of lipid stabilization period, confirmed by a repeat measurement at least 1 week apart
- •- Known active infection or major hematologic, renal, metabolic,
- •gastrointestinal or endocrine dysfunction in the judgment of the
- •investigator
- •- Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months prior to randomization
- •- Current therapeutic anticoagulation with vitamin K antagonist (eg, warfarin), heparin, low-molecular weight heparin, direct thrombin inhibitor, or Factor Xa inhibitor. (Note: anti-platelet agents [eg, aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole] are permitted).
- •- Unreliability as a study participant based on the investigator's (or designee’s) knowledge of the subject (eg, alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis)
- •- Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
- •- Female subject who is not willing to use at least 1 highly effective m
研究者
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