EUCTR2012-000872-40-CZ进行中（未招募）不适用
A pilot study to assess the efficacy and safety of LCQ908 alone and in combination with fenofibrate or Lovaza® in patients with severe hypertriglyceridemia
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •-Male and female subjects ages >18 years of age, inclusive.
- •-History of plasma TG concentration >=890 mg/dl (10 mmol/L) or history of lactescent plasma in the fasting state.
- •-Fasting TG >= 750 mg/dL (8.5 mmol/L) at day -7 or repeat of day -7 one week later for those failing to qualify initially and thought likely to qualify on repeat examination prior to randomization.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
- •-Male and female subjects ages >18 years of age, inclusive.
- •-History of plasma TG concentration >=890 mg/dl (10 mmol/L) or history of lactescent plasma in the fasting state.
- •-Fasting TG >= 750 mg/dL (8.5 mmol/L) at day -7 or repeat of day -7 one week later for those failing to qualify initially and thought likely to qualify on repeat examination prior to randomization.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •-Treatment with Omega-3 fatty acids or niacin or fibrates within 8 weeks of screening.
- •-Patients with confirmed Familial Chylomicronemia Syndrome (FCS) with hyperlipoproteinemia (HLP) Type-I diagnosis or known to be homozygotes or compound heterozygotes for mutations in HLP Type I-causing genes (such as LPL, apoCII, CPIHBP1, or LMF1) prior to screening.
- •-Pancreatitis within 3 months prior to screening.
- •-Uncontrolled type 2 diabetes (T2DM) (as defined by an HbA1c value of =8.0% at screening)
- •-BMI > 40 or history of bariatric surgery.
- •-Nephrotic syndrome, Type 1 diabetes, HIV, HCV or HBV positive.
- •-Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2
- •-History of known allergy to fish/shellfish or any of the ingredients in Lovaza
- •-Heart transplant recipients, participants with implantable cardioverter defibrillators with ventricular tachycardia or ventricular arrhythmia, or participants with very significant cardiovascular disease, as determined by the investigator
- •-Treatment with Omega-3 fatty acids or niacin or fibrates within 8 weeks of screening.
- •-Patients with confirmed Familial Chylomicronemia Syndrome (FCS) with hyperlipoproteinemia (HLP) Type-I diagnosis or known to be homozygotes or compound heterozygotes for mutations in HLP Type I-causing genes (such as LPL, apoCII, CPIHBP1, or LMF1) prior to screening.
- •-Pancreatitis within 3 months prior to screening.
- •-Uncontrolled type 2 diabetes (T2DM) (as defined by an HbA1c value of =8.0% at screening)
- •-BMI > 40 or history of bariatric surgery.
- •-Nephrotic syndrome, Type 1 diabetes, HIV, HCV or HBV positive.
- •-Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2
- •-History of known allergy to fish/shellfish or any of the ingredients in Lovaza
- •-Heart transplant recipients, participants with implantable cardioverter defibrillators with ventricular tachycardia or ventricular arrhythmia, or participants with very significant cardiovascular disease, as determined by the investigator
研究者
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