NCT00141232已完成4 期
A Multicentre, Randomised, Double Blind Placebo Controlled Trial Evaluating Atorvastatin in Factorial With Omega-3 Fatty Acids Cardiovascular Risk Reduction in Patients With Type 2 Diabetes
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.60 个研究点 分布在 1 个国家目标入组 810 人开始时间: 2004年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 810
- 试验地点
- 60
- 主要终点
- Prim objective (16 wks) for atorvastatin: Proportion of pats. who achieve measured
研究概览
简要总结
The AFORRD trial is asking three important questions:
What proportion of people with Type 2 Diabetes are likely to be treated satisfactorily with a fixed dose of a statin that lowers blood cholesterol levels to help reduce the risk of heart disease? To what extent do omega-3 fatty acids lower blood triglyceride levels when given with or without a statin? Are there simple techniques that can help people to take their tablets on a regular basis?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double
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
- •They have a diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to entry.
- •Are not known to have had a cardiovascular event
排除标准
- •They are taking prescribed lipid lowering therapy
- •Have triglycerides > or = 8.0 mmol/L
结局指标
主要结局
Prim objective (16 wks) for atorvastatin: Proportion of pats. who achieve measured
LDL levels <2.6 mmol/L (<100 mg/dl) Prim object (16 wks) for Omega-3 fatty acid:
Prop of pats. who achieve measured triglycerides <1.5 mmol/L (<200 mg/dl)
次要结局
- Prop of pats who achieve LDL levels <2.6 mmol/L (<100 mg/dl) at 52 weeks, taking into account whether the patient received additional atorvastatin therapy or placebo at week 16.
- Prop of pats who achieve triglycerides <1.5 mmol/L (<200 mg/dl) at 52 weeks.
研究者
研究点 (60)
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