ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals

AstraZeneca0 个研究点目标入组 1,294 人开始时间: 2002年2月最近更新: 2009年3月26日

适应症

试验速览

阶段: 4 期
状态: 撤回
发起方: AstraZeneca
入组人数: 1,294
主要终点: Comparison of the rosuvastatin therapy (10mg daily, titrated to 20mg at 12 weeks if necessary), alone or in combination with enhanced compliance initiatives, at 6 months, in bringing subjects with prim. hypercholesterolaemia to the EAS LDL-C target goals

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

24 week open label study to compare the treatment either with rosuvastatin or rosuvastatin plus initiatives to improve compliance. If the subject does not reach the EAS LDL-C treatment goal at week 12, rosuvastatin will be titrated from 10mg to 20mg.

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

•Primary hypercholesterolaemia:
•Statin naïve subjects (LDL-C level > 3.5 mmol/L) or subjects on an ineffective "start dose" of a lipid-lowering therapy (LDL-C level > 3.1 mmol/L).
•CV risk > 20%,
•history of CHD or other established atherosclerotic disease

排除标准

•History of severe adverse events with another HMG-CoA reductase inhibitor
•Secondary hypercholesterolaemia;
•Unstable cardiovascular disease;
•Uncontrolled diabetes, active liver disease;
•Severe hepatic or renal impairment;
•Treatment with cyclosporin.

结局指标

主要结局

Comparison of the rosuvastatin therapy (10mg daily, titrated to 20mg at 12 weeks if necessary), alone or in combination with enhanced compliance initiatives, at 6 months, in bringing subjects with prim. hypercholesterolaemia to the EAS LDL-C target goals

次要结局

To investigate the effect of rosuvastatin, both with and without compliance initiatives on number and percentage of subjects within the EAS or local LDL-C and TC target goals after 12 week therapy,
Safety of treatment.

研究者

发起方

AstraZeneca

申办方类型

Industry

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