NCT00695539已完成不适用
A Multi-centre, Open Label, Non-randomised, Non Interventional, 24 Weeks Study for the Efficacy and Safety of Rosuvastatin Following Its Administration in Real Life Clinical Practice in Greek Hypercholesterolaemic Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 810
- 试验地点
- 1
- 主要终点
- To evaluate the percentage of patients on European LDL-C target at week 12
研究概览
简要总结
This is a single-arm, phase IV, open-label, prospective, non interventional study to evaluate the efficacy, tolerability and safety of rosuvastatin administered for 24 weeks in approximately 900 Greek subjects with hypercholesterolemia under normal clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hypercholesterolaemia who are already in treatment with rosuvastatin according to the approved SPC for no longer than 1 month prior to study entry
- •Patients that are able to read, understand and sign the Patient Information & Consent Form
- •Patients that are willing to comply with all study requirements
排除标准
- •Patients that are likely not to comply with all study requirements
- •Patients that currently participate or have participated in a 3 months period prior to study entry in another clinical trial
- •Female of child bearing potential that do not use a reliable method of contraception. Pregnancy or lactation.
- •Patients that meet any of the contraindications described in the approved SPC
结局指标
主要结局
To evaluate the percentage of patients on European LDL-C target at week 12
时间窗: At 12 weeks of treatment
The assessment of rosuvastatin efficacy in the reduction of low-density lipoprotein cholesterol (LDL-C) in subjects with hypercholesterolemia at week 12 of treatment compared with baseline
时间窗: At 12 weeks of treatment
次要结局
- Safety and tolerability(Throughout the study)
- Changes in HDL-C, TC and TG(At week 12 & 24 of treatment)
研究者
研究点 (1)
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