EUCTR2012-001365-32-NL进行中（未招募）1 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects with Heterozygous Familial HypercholesterolemiaRUTHERFORD-2Reduction of LDL-C with PCSK9 Inhibition in Heterozygous FamilialHypercholesterolemia Disorder 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
- 331
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
- •Diagnosis of heterozygous familial hypercholesterolemia by having met the diagnostic criteria outlined by the Simon Broome Register Group (Scientific Steering Committee, 1991) as defined by the documentation of one of the following in the patient’s past medical record:
- •1. A total cholesterol concentration > 290 mg/dL (> 7.5 mmol/liter) in adulthood or a total cholesterol concentration > 260 mg/dL
- •(> 6.7 mmol/liter) in childhood at an age of less than 16 years, or a LDL-C concentration > 190 mg/dL (> 4.9 mmol/liter) in adulthood or > 155 mg/dL (> 4.0 mmol/liter) in childhood AND tendinous xanthomas in the patient or first- or second-degree relative
- •2. Deoxyribonucleic acid (DNA)-based evidence of mutation in the LDLR, ApoB, or PCSK9 gene
- •3. A total cholesterol concentration > 290 mg/dL (> 7.5 mmol/liter) in adulthood or a total cholesterol concentration > 260 mg/dL (> 6.7 mmol/liter) in childhood at an age of less than 16 years, or a LDL-C concentration > 190 mg/dL (> 4.9 mmol/liter) in adulthood or > 155 mg/dL (> 4.0 mmol/liter) in childhood AND family history of myocardial infarction before age 50 years in a second-degree relative or before age 60 years in a first-degree relative
- •4. A total cholesterol concentration > 290 mg/dL (> 7.5 mmol/liter) in adulthood or a total cholesterol concentration > 260 mg/dL (> 6.7 mmol/liter) in childhood at an age of less than 16 years, or a LDL-C concentration > 190 mg/dL (> 4.9 mmol/ liter) in adulthood or > 155 mg/dL (> 4.0 mmol/liter) in childhood AND family history of raised total cholesterol concentration > 290 mg/dL (> 7.5 mmol/liter) in a first or second-degree adult relative or > 260 mg/dL (> 6.7 mmol/liter) in child, brother, or sister aged younger than 16 years
- •On a stable dose of an approved statin, and on stable dose(s) for all allowed (eg, ezetimibe, bile-acid sequestering resin, stanols, or regulatory-approved and marketed niacin (eg, Niaspan or Niacor)) lipidregulating drugs for at least 4 weeks before LDL-C screening and, in the opinion of the investigator, not requiring uptitration.
- •Fasting LDL-C = 100 mg/dL (2.6 mmol/L) by central laboratory at screening
- •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 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Homozygous familial hypercholesterolemia
- •LDL or plasma apheresis within 4 months prior to randomization
- •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 3 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 serum 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 requires uptitration of their current statin dose (these subjects can be uptitrated and rescreened one month later)
- •Subject has taken in the last 6 weeks prior to LDL-C screening red yeast rice, omega-3 fatty acids ([eg, DHA and EPA combined] [> 1000 mg/day]) or prescription lipid-regulating drugs (eg, fibrates and derivatives) other than statins, ezetimibe, bile-acid sequestering resin, stanols, or regulatory approved and marketed niacin (eg, Niaspan or Niacor)
- •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 screeningActive 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, 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
相似试验
已完成
3 期
Study assessing impact of additional reduction of bad cholesterol on heart related diseases with AMG 145 when used in combination with cholesterol lowering medicationsCTRI/2014/01/004324Amgen Technology Pvt Ltd266
进行中（未招募）
不适用
A research study to find out if people with Primary Generalized Tonic-Clonic Seizures, by taking perampanel in addition to their normal epilepsy medicine(s), have fewer seizures and feel better. Either perampanel (real medicine) or placebo (pretend medicine that looks the same as the real medicine) will be given in addition to ordinary epilepsy medicines. Who gets which is decided randomly. There is an option to continue into the Follow-on (Extension) Phase of the study.Primary Generalized Tonic-Clonic SeizuresMedDRA version: 17.0Level: HLTClassification code 10018101Term: Generalised tonic-clonic seizuresSystem Organ Class: 100000004852EUCTR2011-000265-12-PLEisai Limited164
进行中（未招募）
1 期
A Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events when AMG 145 is used in combination With Statin Therapy In Patients with Clinically Evident Cardiovascular DiseaseMedDRA version: 16.1Level: LLTClassification code 10058110Term: DyslipidemiaSystem Organ Class: 100000004861DyslipidemiaEUCTR2012-001398-97-NOAmgen Inc27,564
进行中（未招募）
不适用
A Double-blind, Randomized, Placebo-controlled, Multicenter Study toAssess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality andMorbidity in Heart Failure (HF) Subjects with Symptomatic Left VentricularSystolic Dysfunction and Anemia. - RED-HF Trial – Reduction of Events with Darbepoetin alfa in Heart Failure TrialHeart Failure Subjects with Symptomatic Left Ventricular Systolic Dysfunction and AnemiaMedDRA version: 8.1Level: PTClassification code 10007559Term: Cardiac failure congestiveEUCTR2005-005278-59-ATAmgen Inc.3,400
进行中（未招募）
1 期
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or StrokeDyslipidemiaMedDRA version: 21.0Level: LLTClassification code 10058110Term: DyslipidemiaSystem Organ Class: 100000004861EUCTR2018-004565-14-FIAmgen Inc.12,000