NCT00395473已完成3 期
Ezetimibe Added to Statin Therapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 141
- 主要终点
- Percent (%) reduction in plasma low-density lipoprotein cholesterol (ldl-c) concentration after 6 weeks of treatment
研究概览
简要总结
In the context of australian general practice, to determine the efficacy and safety of ezetimibe 10mg/statin 40mg coadministration in patients with uncontrolled cholesterol receiving statin 40mg or more.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patients who will remain on a stable statin dose of 40mg or more, for the duration of the study
- •Patients with coronary heart disease or diabetes mellitus whose cholesterol levels remain above the initial threshold for government subsidy after at least 3 months of treatment at a daily dose of 40mg or greater of a statin
排除标准
- •Illnesses such as congestive heart failure nyha class iii or iv
- •Uncontrolled hypertension
- •Myocardial infarction
- •Coronary bypass surgery or angioplasty with or without stent within 3 months of the enrolment visit
- •Unstable angina pectoris or unstable or severe peripheral vascular disease
- •Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, ex: type i or type ii diabetes mellitus that is poorly controlled
- •Serum creatinine >0.18mmol/l at enrolment or active renal disease with significant proteinuria
- •Disorders of the haematologic, digestive (including malabsorptive disorders)
- •Central nervous system including cerebrovascular disease and degenerative diseases that would limit study evaluation or participation
- •Active acute or chronic hepatobiliary disease
- •Patients taking the following medication: medications known to interact with statin medication including antifungal azoles, macrolide antibiotics, telithromycin; nefazodone; protease inhibitors; amiodarone; danazol and verapamil; fibrates; cyclosporin
- •Tg >4.0mmol/l while using a statin
结局指标
主要结局
Percent (%) reduction in plasma low-density lipoprotein cholesterol (ldl-c) concentration after 6 weeks of treatment
次要结局
未报告次要终点
研究者
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