EUCTR2012-001363-70-CZ进行中（未招募）不适用
A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia.LAPLACE - 2LDL-C Assessment w/ PCSK9 MonoclonaL Antibody Inhibition Combined with Statin ThErapy
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 1,899
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 = 80 years of age
- •Subjects not taking a statin at screening must have a fasting LDL-C of at least 150 mg/dl (4.0 mmol/L) as determined by central laboratory
- •Subjects already on a non-intensive statin (see Appendix D) at screening must have a fasting LDL-C at screening of = 100 mg/dL (2.6 mmol/L) as determined by central laboratory
- •Subjects already on a intensive statin (see Appendix D of Protocol) at screening must have a fasting LDL-C at screening of = 80 mg/dL (2.1 mmol/L) as determined by central laboratory
- •Negative pregnancy test, AST and ALT = 2 times ULN, CK = 3 times ULN as determined by central laboratory at the end of the lipid stabilization period
- •Fasting triglycerides = 400 mg/dL (4.5 mmol/L) by central laboratory at screening
- •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 1300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •Current or prior history of statin intolerance, or any intolerance to rosuvastatin, atorvastatin, or simvastatin.
- •Subject, who in the opinion of the investigator, requires maximal statin therapy
- •Personal or family history of hereditary muscular disorders
- •NYHA III or IV heart failure, or last known left ventricular ejection fraction < 30%
- •Uncontrolled serious 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 6 months prior to randomization
- •Planned cardiac surgery or revascularization
- •Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c > 8.5%), newly diagnosed type 2 diabetes (within 6 months of randomization), or laboratory evidence of diabetes during screening (fasting plasma glucose = 126 mg/dL [7.0 mmol/L] or HbA1c = 6.5%) without prior diagnosis of diabetes
- •Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg
- •Subject has taken in the last 6 weeks prior to LDL-C screening red yeast rice, > 200 mg/day niacin, > 1000 mg/day omega-3 fatty acids ( DHA and EPA combined), stanols or prescription lipid-regulating drugs (eg, bileacid sequestering resins, fibrates and derivatives) other than statins and ezetimibe
- •Subject has taken a cholesterylester transfer protein (CETP) inhibitor in the last 12 months prior to LDL-C screening, such as: anacetrapib, dalcetrapib or evacetrapib.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)
- •Uncontrolled hypothyroidism or hyperthyroidism as defined by thyroid stimulating hormone (TSH) < 1.0 time 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
- •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.
- •CK > 3 times the ULN at screening
- •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
- •Unreliability as a study participant based on the investigator's (or designee’s) knowledge of the subject (eg, alcohol or other drug abuse in the past year, 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 has either (1) not used at least 1 highly effective method of birth control for at least 1 month prior to screening or
研究者
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