NCT00344370已完成3 期
Double-Blind, Follow-On Study of Pitavastatin (4 mg) Versus Atorvastatin (20 mg and 40 mg), With a Single-Blind Extension of Treatment, in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Kowa Research Europe35 个研究点 分布在 6 个国家目标入组 214 人开始时间: 2006年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 35
- 主要终点
- NCEP LDL-C Target Attainment
研究概览
简要总结
This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type II diabetes mellitus
- •Combined dyslipidemia
- •Completed NK-104-305 (NCT00309751)
排除标准
- •Withdrawal from NK-104-305 (NCT00309751)
研究组 & 干预措施
Pitavastatin
Experimental
Pitavastatin 4 mg QD
干预措施: Pitavastatin (Drug)
Atorvastatin
Active Comparator
Atorvastatin 40 mg
干预措施: Atorvastatin (Drug)
结局指标
主要结局
NCEP LDL-C Target Attainment
时间窗: 44 weeks
Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.
次要结局
- Percent Change From Baseline in LDL-C(Basseline to 44 weeks)
研究者
研究点 (35)
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