EUCTR2021-003168-28-NL进行中（未招募）1 期
Impact of Triglyceride-Lowering on Inflammatory Activity in Patients with Hypertriglyceridemia
Academic Medical Center (AMC), department of Internal Medicine0 个研究点目标入组 30 人开始时间: 2022年4月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- Female
入选标准
- •- Adults above 18 years old
- •- Triglyceride levels > 4mmol/l (350 mg/dl)
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Molecularly diagnosed familial chylomicronemia syndrome (homozygous and/or compound heterozygous)
- •- Use of fibrates or fish oil: both have to be discontinued for at least 4 weeks prior to baseline visit
- •- Uncontrolled diabetes (HBa1C > 70 mmol/mol)
- •- Alcohol intake > 4c/day
- •- ASAT/ALAT > 3x ULN
- •- Renal insufficiency, defined as eGFR < 30 ml/min
- •- Platelet count < 150.000 and > 450.000 /mm3
- •- Pancreatitis < 8 weeks prior to baseline visit
- •- Body mass index (BMI) > 35.0 kg/m2
- •- Premenopausal women not using birth-control
- •- Uncontrolled hypertension (systolic > 180 mmHg; diastolic > 105 mmHg)
- •- Diagnosis of (active) malignancy in last 5 years
- •- Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
- •- Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study
研究者
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