NCT00631189已完成4 期
Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Subjects With Type IIa and IIb Hypercholesterolaemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 668
- 试验地点
- 1
- 主要终点
- Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation after 8 weeks of treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •subjects presenting type IIa or IIb primary hypercholesterolaemia diagnosed for at least 3 months, in a context of primary prevention with at least two associated cardiovascular risk factors and: (i)either "naive" to all lipid-lowering therapy, (ii)or treated with a statin (treatment ongoing or stopped during the previous 8 weeks)
排除标准
- •homozygous or heterozygous familial hypercholesterolaemia
- •hypertriglyceridaemia (TG ≥ 4 g/l)
- •subjects at high cardiovascular risk according to the AFSSAPS 2005 definition (coronary artery disease or history of documented vascular disease, high cardiovascular risk type 2 diabetes, subject in primary prevention with a 10-year CHD risk > 20%)
- •history of adverse events or hypersensitivity to an HMG Co-A reductase inhibitor (particularly a history of myopathy)
- •concomitant use of any drugs not authorized during the study
- •active liver disease with elevation of serum transaminases (ASAT, ALAT) more than twice the upper limit of normal
- •CPK more than 3 times the upper limit of normal
- •moderate or severe renal failure (creatinine clearance < 6 ml/min)
- •poorly controlled hypothyroidism; poorly controlled hypertension (DBP > 95 mm Hg and/or SBP > 180 mm Hg)
研究组 & 干预措施
1
Active Comparator
Rosuvastatin and Pravastatin
干预措施: Rosuvastatin (Drug)
1
Active Comparator
Rosuvastatin and Pravastatin
干预措施: Pravastatin (Drug)
2
Active Comparator
Rosuvastatin and Atorvastatin
干预措施: Rosuvastatin (Drug)
2
Active Comparator
Rosuvastatin and Atorvastatin
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks
时间窗: Change from baseline and after 8 weeks of treatment
To compare the percentages of LDL-C level variation. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data
次要结局
- To Compare the Percentage of Patients Reaching the Overall LDL-C Goal According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients(Not done)
- To Compare the Percentage of Patients Reaching the LDL-C Goal, in Relation to the Number of Risk Factors, According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients(Not done)
- Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment(from baseline and after 8 weeks of treatment)
- Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment(After 8 weeks of treatment)
- Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks(Baseline and after 8 weeks of treatment)
- Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment(baseline and after 8 weeks of treatment)
- Compare the Percentage of Variation of C-reactive Protein (CRP)(baseline and after 8 weeks of treatment)
- Compare the Percentage of Variation of Phospholipase A2 (PLA2)(from baseline and after 8 weeks of treatment)
- Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients(from baseline and after 8 weeks of treatment)
- Compare the Numbers of Patients Achieving the LDL-C Goal According to the European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemic Patients
- To Evaluate Clinical and Laboratory Safety(duration of study)
研究者
研究点 (1)
Loading locations...
相似试验
终止
4 期
Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mgHypercholesterolaemiaNCT00427960AstraZeneca55
已完成
4 期
Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart DiseaseHypercholesteremiaNCT00329160AstraZeneca214
已完成
3 期
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatinFamilial HypercholesterolemiaNCT00355615AstraZeneca173
已完成
不适用
A Study To verify the efficacy of ROsuvastatin 5 mg as an aggressive lipid lowering therapy for hypercholesterolemia (No.2)hypercholesterolemiaJPRN-UMIN000000912Graduate School of Medicine, the University of Tokyo900
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial HypercholesterolemiaHomozygous Familial Hypercholesterolemia (HoFH)NCT02226198AstraZeneca20