NCT00889226已完成4 期
A Randomized, Open Label, Dose Titration Study to Evaluate the Efficacy and Safety of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
JW Pharmaceutical0 个研究点目标入组 161 人开始时间: 2008年4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
- 161
- 主要终点
- Proportion of Patients Achieving LDL- C<100mg/dL
研究概览
简要总结
A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia
详细描述
To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 25yrs~75yrs
- •Fasting TG <400mg/dL, LDL-C ≥130mg/dL
- •3months > Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%
排除标准
- •Type1 DM, Gestational diabetes
- •Patient need to treat with Insulin
- •Patient with operational treatment for severe diabetic complication
- •Uncontrolled Hypothyroidism
- •Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4)
- •Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)
- •Renal disorder (Serum creatinine ≥ 2.0mg/dL)
- •Hepatic disorder (AST or ALT ≥ 2.5 X UNL)
- •Creatinine Kinase > 2.5 X UNL
- •Gravida or lactation phase
- •Administration of Atorvastatin, Rosuvastatin, Pitavastatin
研究组 & 干预措施
Pitavastatin Group
Experimental
干预措施: Pitavastatin (Drug)
Atorvastatin Group
Active Comparator
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Proportion of Patients Achieving LDL- C<100mg/dL
时间窗: After 16wk drug administration
compare the proportion of patients achieving LDL- C\<100mg/dL
次要结局
- The Change of LDL-C(After 16wk drug administration)
研究者
相似试验
Unknown
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