NCT02305355已完成4 期
Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia
Kuhnil Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- The mean percent change of Triglyceride(TG)
研究概览
简要总结
Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in subjects with type 2 Diabetes combined with hyperlipidemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LDL-C < 100mg/dL, TG > 150mg/dL, patients on statin treatment for at least 6 weeks prior to randomization.
- •Type 2 Diabetes
- •HbA1c ≤ 10.0
排除标准
- •Type 1 Diabetes
- •Patients with PPAR gamma agonist therapy
- •Patients with acute MI, Unstable angina within 6 months
- •History of malignant tumor within 2 years
- •Women with pregnant, breast-feeding
研究组 & 干预措施
Omega-3-acids ethylesters 90 4g, any statin
Experimental
干预措施: Omega-3-acids ethylesters 90 4g (Drug)
Omega-3-acids ethylesters 90 4g, any statin
Experimental
干预措施: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin (Drug)
any statin
Active Comparator
干预措施: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin (Drug)
结局指标
主要结局
The mean percent change of Triglyceride(TG)
时间窗: from baseline at week 16
次要结局
- The mean percent change of LDL-C(from baseline at week 16)
- The mean percent change of HDL-C(from baseline at week 16)
- The mean percent change of HBA1c(from baseline at week 16)
- The mean percent change of FPG(from baseline at week 16)
- The mean percent change of hs-CRP(from baseline at week 16)
- The mean percent change of PAI-1(from baseline at week 16)
- The mean percent change of Apolipoprotein A1(from baseline at week 16)
- The mean percent change of apolipoprotein B(from baseline at week 16)
- The mean percent change of Total Cholesterol(TC)(from baseline at week 16)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Effects of Omega-3 Fatty Acids on Platelets in Patients With Coronary Artery Disease With HypertriglyceridemiaCoronary Artery DiseaseNCT01086163HeartDrug Research LLC30
Unknown
不适用
Effect of Re-esterified Triglyceride (rTG) Form Omega-3 Supplements on Dry Eye Following Cataract SurgeryDry EyeNCT04411615Samsung Medical Center30
招募中
4 期
Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined DyslipidemiaDyslipidemiasAtherosclerosisDiabetes Mellitus, Type 2NCT05365438Seoul National University Bundang Hospital105
已完成
4 期
Omacor and Cardiovascular Risk Factors in HIV Patients on HAART TreatmentHuman Immunodeficiency VirusIschemic Heart DiseaseNCT00296153Pronova BioPharma51
Unknown
3 期
Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3-acids Ethylesters 90 in Type Ⅱb HyperlipidemiaHyperlipidemia, Familial CombinedNCT02035215Kuhnil Pharmaceutical Co., Ltd.80