EUCTR2011-001483-21-SE进行中（未招募）不适用
A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long-term Phase III Trial Assessing the Safety and Efficacy of 50 µg and 100 µg/day of eprotirome in Patients with Heterozygous Familial Hypercholesterolaemia who are on Optimal Standard of Care - AKKA
Karo Bio AB0 个研究点目标入组 1,050 人开始时间: 2011年5月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,050
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
- •1)Patients with confirmed HeFH who are 18 years of age or older, understand the study procedures and agree to participate in the study by giving written informed consent at Visit 1 and must have:
- •a) Presence of clinical atherosclerotic disease that confers high risk for CAD events together with an LDL-C >2 mmol/L (>80 mg/dL) at Visit 2, based on one or more of the following; or
- •b) Presence of at least 2 risk factors for CVD (other than the HeFH diagnosis) together with an LDL-C >2.5 mmol/L (>100 mg/dL) at Visit 2:
- •2) Patients should be on an optimal standard of care, defined as being on a stable dose of statin (at least half of the maximum dose of either rosuvastatin, atorvastatin, or simvastatin) with or without ezetimibe for at least 8 weeks prior to randomisation. If lower doses of rosuvastatin, atorvastatin, or simvastatin or any dose of fluvastatin or pravastatin are used the reasons must be clearly documented.
- •3) Women must not be pregnant or lactating. Women of childbearing potential must use a medically acceptable form of contraception at least 4 weeks prior to the start of the study and for at least 4 weeks after the patient’s last study visit. Subjects who are on systemic hormonal contraceptives must agree to use an additional method of contraception (barrier method).
- •4) Diabetes Mellitus (Type 1 and Type 2) for Type 2 (only metformin, sulfonylureas, alpha-glucosidase inhibitors or DPP-4s as diabetic medications are allowed)
- •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 1050
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Other dyslipidaemic or metabolic disorders that could affect the evaluation of eprotirome in HeFH, such as increased serum TG >4.5 mmol/L, HbA1c >8.5%, secondary dyslipidaemia or ongoing or planned apharesis
- •2) cardiac diseases that may interfere with the safety evaluation of eprotirome, such as congestive heart failure (NYHA III and IV), planned percutaneous coronary intervention, coronary
- •artery bypass surgery, uncontrolled hypertension (defined as systolic blood pressure equal to or more than 160 mmHg or diastolic blood pressure equal to or more than 100 mmHg) or evidence of cardiac electrophysiologic instability including uncontrolled sick sinus syndrome, sino-atrial or atrioventricular block, ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardia with a ventricular response heart rate (>100 bpm) or a QTcF >450 ms
- •3) Previous stroke (includes definite or presumed cerebral ischaemia/infarction)
- •4) No other lipid-lowering medication with the exception of statins and ezetimibe are allowed
- •5) Patients with disturbed thyroid function, thyrotoxicosis, taking thyroid hormone or anti-thyroid medication are excluded
- •6) Drugs known to affect thyroid function tests are also prohibited
- •7) Patients with liver dysfunction such as: AST or ALT or ALP >1.5 x ULN, total bilirubin >ULN, active hepatobiliary disease, cholestasis, or serologic evidence of past or active hepatitis B or hepatitis C, acquired immune deficiency syndrome, positive HIV, substantial consumption of alcohol or drug abuse
- •8) Patients with serum creatinine >160 mmol/L or unexplained serum creatine kinase >3 x ULN
- •9) Patients on oral anticoagulant therapy other than vitamin K antagonists and anti-platelets agents
- •10) Rheumatoid arthritis; history of cancer, history of or current primary or secondary adrenal insufficiency or any other condition that in the opinion of the investigator confound the evaluation and interpretation of efficacy and or safety data.
研究者
相似试验
进行中（未招募）
不适用
/AHeterozygous Familial HypercholesterolaemiaMedDRA version: 14.0Level: LLTClassification code 10057099Term: Heterozygous familial hypercholesterolaemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-001483-21-CZKaro Bio AB1,050
招募中
3 期
A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long-term Phase III Trial Assessing the Safety and Efficacy of 50 microgram and 100 mircrogram/day of eprotirome in Patients with Heterozygous Familial Hypercholesterolaemia who are on Optimal Standard of Care100274241001331710003216familial hypercholesterolemiaNL-OMON36068Karo Bio AB160
进行中（未招募）
不适用
A clinical study on patients suffering from high level cholesterols. The aim is to evaluate safety and efficacy of a new medicinal drug.Heterozygous Familial HypercholesterolaemiaMedDRA version: 14.0Level: LLTClassification code 10057099Term: Heterozygous familial hypercholesterolaemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-001483-21-ATKaro Bio AB1,050
进行中（未招募）
不适用
Eprotirome in Patients with HeFH who are on Optimal Standard of CareEUCTR2011-001483-21-GBKaro Bio AB1,050
进行中（未招募）
1 期
A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long-term Phase III Trial Assessing the Safety and Efficacy of 50 µg and 100 µg/day of eprotirome in Patients with Heterozygous Familial Hypercholesterolaemia who are on Optimal Standard of Care - AKKAHeterozygous Familial HypercholesterolaemiaMedDRA version: 14.1Level: LLTClassification code 10057099Term: Heterozygous familial hypercholesterolaemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-001483-21-DKKaro Bio AB