EUCTR2011-001529-26-SE进行中（未招募）不适用
A Randomized, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C, Compared with Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor
适应症
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
- 150
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
- •- Subject not on a statin or on a low dose statin - as defined by a maximal total weekly dose corresponding to 7 times the smallest available tablet size. For the listed statins below, the following maximum total prescribed weekly dosages apply:
- •a) atorvastatin - 70 mg or less
- •b) simvastatin - 140 mg or less
- •c) pravastatin - 140 mg or less
- •d) rosuvastatin - 35 mg or less
- •e) lovastatin -1 40 mg or less
- •f) fluvastatin - 280 mg or less
- •- Subject not at LDL-C goal as evidenced by their NCEP ATP III risk category and the following LDL-C levels by central laboratory at screening:
- •a) Fasting LDL-C = 100 mg/dL for subjects with diagnosed CHD or are CHD risk equivalent or
- •b) Fasting LDL-C = 130 mg/dL for subjects without diagnosed CHD or risk equivalent and 2 or more risk factors or
- •c) Fasting LDL-C = 160 mg/dL for subjects without diagnosed CHD or risk equivalent and with 1 or no risk factors
- •- Subject has a history of statin intolerance as evidenced by both of the following (per subject or physician report):
- •- Tried at least two statins and was unable to tolerate any dose or increase statin dose above the total weekly maximum doses listed in Section 4.1.3 due to intolerable myalgia (muscle pain, soreness, weakness, or cramps) or myopathy (myalgia plus a raised CK)
- •- Symptoms resolved or improved when statin dose was decreased or discontinued
- •- Lipid lowering therapy has been stable prior to enrollment for at least:
- •a) 4 weeks if currently on a statin and/or bile-acid sequestering resin and/or stanol; if subject is on ezetimibe at start of screening, ezetimibe must be discontinued for = 4 weeks before LDL-C screening
- •b) 12 weeks if taking any other lipid modifying agents (eg niacin, fibrates and derivative, etc.)
- •- Fasting triglycerides = 400 mg/dL 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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •- NYHA III or IV heart failure, or 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 within 20 weeks of screening
- •- Type 1 diabetes or newly diagnosed (within 3 months of randomization) type 2 diabetes, or poorly controlled type 2 diabetes (HbA1c > 8.5%)
- •- Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg, confirmed with repeat measurement
- •- Subject has taken during > 2 weeks in the last 3 months prior to LDL-C screening: prescription lipid-regulating drugs other than statins or ezetimibe, such as fibrates and derivatives, bile-acid sequestering resins; red yeast rice, niacin (> 200 mg/day), or omega-3 fatty acids (>1000 mg/day)
- •- Treatment in the last 3 months prior to LDL-C screening with any of the following drugs: cyclosporine, systemic steroids (IV, intramuscular [IM], or PO), 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 TSH below the lower limit of normal or >1.5 times the 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, 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
- •- 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 is not willing to use at least one highly effective method of birth control during treatment and for an additional 15 weeks after the end of treatment unless subject is sterilized or postmenopausal; postmenopausal is defined as 12 continuous months of spontaneous amenorrhea; highly effective methods include birth control pills, shots, implants, or patches, intrauterine devices (IUDs), sexual activity with a male partner who has had a vasectomy, condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide
- •- Subject is pregnant or breast feeding, or
研究者
相似试验
进行中（未招募）
不适用
Study to assess the tolerability and efficacy of AMG 145 in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.HypercholesterolaemiaMedDRA version: 14.0Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-001529-26-FIAmgen Inc150
进行中（未招募）
1 期
Study to assess the tolerability and efficacy of AMG 145 in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.EUCTR2011-001529-26-DKAmgen Inc150
进行中（未招募）
1 期
Study to assess the tolerability and efficacy of AMG 145 in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.HypercholesterolaemiaMedDRA version: 14.0Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-001529-26-BEAmgen Inc150
进行中（未招募）
不适用
Study to assess the tolerability and efficacy of AMG 145 in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.HypercholesterolaemiaMedDRA version: 13.1Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-001529-26-ESAmgen Inc150
进行中（未招募）
1 期
Study to assess the tolerability of P-3058 nail solution in paediatric patients affected by mild-to-moderate onychomycosisOnychomycosisMedDRA version: 16.1Level: PTClassification code 10030338Term: OnychomycosisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2013-005595-17-DEPolichem S.A.35