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临床试验/EUCTR2005-006041-16-GB
EUCTR2005-006041-16-GB进行中(未招募)1 期

Double-blind follow on study of pitavastatin (4 mg)versus atorvastatin (20 and 40 mg), with a single-blind extension of treatment, in patients with type II diabetes mellitus and combined dyslipidemia

Kowa Research Europe Ltd.0 个研究点目标入组 250 人开始时间: 2007年1月14日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
250

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

入选标准

  • All patients entering this study must have satisfied inclusion/exclusion criteria for the previous core study (NK-104-305, EudraCT number 2005-001038-34). As participants in Study NK 104 305, patients have previously received pitavastatin (at 2 mg up-titrated to 4 mg QD after 4 weeks) or a comparator (atorvastatin 10 mg up-titrated to 20 mg QD after 4 weeks) for a total of 12 weeks and followed a diet according to EAS guidelines (Appendix A) for 18 to 20 weeks. To be eligible for participation in this study the patients must have completed 12 weeks of active treatment in the core study (NK-104-305) and continue to follow the diet according to EAS guidelines.
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • All patients entering this study must have satisfied inclusion/exclusion criteria for the previous core study (NK-104-305).

研究者

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