NCT00462748已完成3 期
A MC, DB, Rand, Study to Evaluate Efficacy, Safety and Tolerability of Eze/Simva 10/40 mg, Atorva 40 mg, Rosuva 10 mg in Achieving LDL-C <2 mmol/l in Pts With CVD...on Simva 40 mg With LDL-C ³2 mmol/l
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 786
- 主要终点
- Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End
研究概览
简要总结
To evaluate the percentage of patients with either established cardiovascular disease (CVD), at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C > 2mmol/l, who are able to attain the recommended LDL-C target of < 2mmol/l following 6 weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin 10mg.
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
- Double (Participant, Investigator)
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
- •Patient Is Male Or Female And Aged Over 18
- •Patient Provides Written Informed Consent
- •Patient Has A Fasting Ldl-C Level >2mmol/L At Both Visit 1 And Again At Visit 2
- •Patient Has Established Cvd, Diabetes Or At "High Risk" Of Cvd (>20 % Risk Over 10 Years, Framingham Scale)
- •Patient Has Taken Simvastatin 40mg Continuously For The Past 6 Weeks
- •Patient Has A Fasting Triglyceride Level Of <3.7mmol/L
- •Patient Has Hba1c <9% At Visit 1
- •Patient Is 75% Compliant With Medication Between Visit 1 And Visit 2
排除标准
- •Patient Is Hypersensitive To Any Of The Study Medications Or Their Components
- •Patient Has A History Of, Or Active Liver Disease (Persistent Elevation Of Alt / Ast (>3xuln)
- •Patient Is Pregnant, Lactating, Or A Female Patient Of Childbearing Potential Not Using Adequate Contraception
- •Patient Has Severe Renal Impairment: Creatinine Clearance <30ml/Min (Cockcroft-Gault Equation) (In Patients With Moderate Renal Impairment: <60ml/Min, The Dose Of Rosuvastatin Will Be 5mg In Line With The Spc)
- •Patient Has Uncontrolled Endocrine Or Metabolic Disease Known To Influence Serum Lipids Or Lipoproteins (I.E. Secondary Causes Of Hyperlipidaemia Such As Hypothyroidism Or Hyperthyroidism)
- •Patient Has A Recent History Of, Or Current, Alcohol Abuse
- •Patient Has Ck >10 X Uln At Visit 1 Or Visit 2
- •Patient Has Fasting Ldl-C >4.2mmol/L
- •Patient Has Any Acute Or Serious Condition, Or History Suggestive Of Myopathy Or Predisposing To The Development Of Renal Failure Secondary To Rhabdomyolysis (E.G. Sepsis, Hypotension, Major Surgery, Trauma, Severe Metabolic, Severe Endocrine And Electrolyte Disorders Or Uncontrolled Seizures)
研究组 & 干预措施
1
Experimental
Arm 1: Drug
干预措施: ezetimibe (+) simvastatin (Drug)
结局指标
主要结局
Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End
时间窗: 6 Weeks
Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of \<2mmol/l in fasting LDL-C at study end.
次要结局
未报告次要终点
研究者
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