NCT01185236Unknown4 期
A Single Center, Open Label, Randomized Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- change of ApoB/ApoA1
研究概览
简要总结
A single center, open label, randomized, clinical trial comparing ApoB/ApoA ratio of Vytorin 10/20mg vs atorvastatin 20mg treatment.
DM2 patients will be screened for inclusion criteria. Patients (n=66 in each arm) will be randomized to either Ezetimibe/simvastatin 10/20mg or atorvastatin 20mg after 4 week washout or TLC period. Primary and secondary endpoints will be assessed at week 12.
Primary endpoint:
- change of ApoB/ApoA ratio at week 12.
Secondary endpoint:
- Change of lipid parameters (TC, LDL-C, HDL-C, TG, apoB 48) at week 12.
- Change of HbA1C at week 12.
- Change of HOMA index at week 12
- HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5
- Change of hsCRP at week 12
- Safety assessment
Hypotheses:
- Three months treatment of Vytorin 10/20mg will be superior to atorvastatin 20mg in ApoB/ApoA ratio.
- In DM patients, Ezetimibe/Simvastatin Combination will be well-tolerated.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypercholesterolemia (baseline screening LDL-C > 100 mg/dL)
- •In case of medication, stable doses of oral hypoglycemic agents for at least three months
- •HbA1c <8.5%
排除标准
- •Chronic renal failure: creatinine > 3.0 mg/dL
- •Serious liver disease (> x3 LFT UNL)
- •Congestive heart failure
- •Stroke or MI/coronary intervention during the preceding 3 months.
- •CK > x 2.5 UNL
- •Unstable hypo/hyperthyroidism
- •Pregnant/lactating woman, or woman intending to become pregnant
- •Subject with any clinically significant condition or situation, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
研究组 & 干预措施
simvastatin/ezetimibe (vytorin) group
Experimental
vytorin 10/20mg po once daily for 12weeks
干预措施: simvastatin/ezetimibe (Drug)
atorvastatin group
Active Comparator
atorvastatin 20mg po once daily for 12weeks
干预措施: atorvastatin 20mg (Drug)
结局指标
主要结局
change of ApoB/ApoA1
时间窗: after 12 weeks' treatment
change of ApoB/ApoA1
次要结局
- change of lipid profile(12weeks)
- change of HbA1c(12weeks)
- change of HOMA index(12weeks)
- change of hsCRP(12weeks)
- safety(during 12weeks of treatment)
研究者
研究点 (1)
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