NCT00240357撤回4 期
Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement of LDL Goals. - Denmark
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 入组人数
- 1,175
- 试验地点
- 109
- 主要终点
- The primary endpoint is the number and percentage of subjects from each group (rosuvastatin or rosuvastatin + a compliance enhancement tool) who reached the DSAM LDL-C target goal (LDL-C < 3.0 mmol/L) after 6 months therapy (24 weeks).
研究概览
简要总结
The purpose of the study is to determine whether an Internet based compliance tool is superior to common diet counselling in patients with hypercholesterolemia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Available personal mailbox and access to the Internet
- •Primary hypercholesterolemia with CV risk > 20% over 10 years judged by the investigator or a history of ischemic heart disease or other established atherosclerotic disease (claudicatio intermittens, apoplexia cerebri (ischaemic stroke)) or stable diabetes mellitus
- •Fasting LDL-C level > 3.2 mmol/L
排除标准
- •Known heterozygous or homozygous familial hypercholesterolemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
- •Documented secondary hypercholesterolemia of any cause except stable diabetes mellitus (type 1 or type 2)
- •History of serious adverse effect or hypersensitivity reactions to statins, in particular any history of myopathy
结局指标
主要结局
The primary endpoint is the number and percentage of subjects from each group (rosuvastatin or rosuvastatin + a compliance enhancement tool) who reached the DSAM LDL-C target goal (LDL-C < 3.0 mmol/L) after 6 months therapy (24 weeks).
次要结局
- Compliance with study drug assessed by tablet count data
- Number and percentage of subjects within the DSAM LDL-C target goal after 3 months therapy
- Number and percentage of subjects increasing rosuvastatin dosage from 10 mg to 20 mg at week 12
- Percentage change in TC, HDL-C, LDL-C, TG from week 0 to week 24
- Change in weight after 6 months therapy
- Change in waistline after 6 months therapy
研究者
研究点 (109)
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