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临床试验/NCT00541697
NCT00541697已完成3 期

A Double-Blind, Multicenter Study to Assess the LDL-C Lowering of Combination Tablets Ezetimibe/Simvastatin (10mg/20mg) and Ezetimibe/Simvastatin (10mg/40mg) Compared to Atorvastatin 20mg in Patients With Type II Diabetes.

Organon and Co0 个研究点目标入组 648 人开始时间: 2005年1月19日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
648
主要终点
Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment

研究概览

简要总结

A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently being treated with Atorvastatin 10 mg for at least 6 weeks
  • Have Type 2 Diabetes
  • Weight must be stable for more than 6 weeks before entering the study

排除标准

  • Consume more than 14 alcoholic drinks per week.
  • Pregnant or lactating
  • Have taken another investigation drug within 3 months of starting this study
  • History of congestive heart failure, heart attack, coronary artery bypass surgery
  • Uncontrolled high blood pressure
  • HIV positive
  • History of cancer in the last 5 years

结局指标

主要结局

Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment

时间窗: 6 Weeks

次要结局

  • Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment(6 Weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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