NCT00427960终止4 期
A Phase IV, 6-week, Randomised, Double-blind, Multicentre, Parallel Group, Comparative Study to Evaluate the Efficacy of Rosuvastatin 5mg and Atorvastatin 10mg in UK Asian Subjects With Primary Hypercholesterolaemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)
研究概览
简要总结
The purpose of this study is to compare the effectiveness and safety of rosuvastatin 5mg in lowering blood cholesterol, compared to one other medicine, atorvastatin 10mg in Asian patients in the UK.
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
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
- •Self described Asian, first or second generation
- •Male or female > or = 18 years with primary hypercholesterolaemia.
排除标准
- •Use of cholesterol lowering drugs from visit 1
- •Homozygous familial hypercholesterolaemia
- •Active arterial disease within 3 months of study entry
- •Poorly controlled diabetes
- •Uncontrolled hypothyroidism
- •Active liver disease
- •History of alcoh/drug abuse.
研究组 & 干预措施
rosuvastatin
Active Comparator
rosuvastatin 5 mg
干预措施: Dietary advice (Behavioral)
rosuvastatin
Active Comparator
rosuvastatin 5 mg
干预措施: rosuvastatin (Drug)
atorvastatin
Active Comparator
atorvastatin 10 mg
干预措施: Dietary advice (Behavioral)
atorvastatin
Active Comparator
atorvastatin 10 mg
干预措施: atorvastatin (Drug)
结局指标
主要结局
Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)
时间窗: 6 weeks (baseline) and 12 weeks
Calculated as LDL-C at Week 6 - LDL-C at Week 12\] \* 100
次要结局
- The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L(6 weeks (Baseline) and 12 weeks)
- The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L(6 weeks (baseline) and 12 weeks)
- The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category.(6 weeks (baseline) and 12 weeks)
- The Percentage Change From Baseline(week6) in TC(6 weeks (baseline) and 12 weeks)
- The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)(6 weeks (baseline) and 12 weeks)
- The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L(6 weeks (baseline) and 12 weeks)
- The Percentage Change From Baseline (Week 6)in Non-HDL-C(6 weeks (baseline) and 12 weeks)
- The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)(6 weeks (baseline) and 12 weeks)
- The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)(6 weeks (baseline) and 12 weeks)
- The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio(6 weeks (baseline) and 12 weeks)
- The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio(6 weeks (baseline) and 12 weeks)
- The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio(6 weeks (baseline) and 12 weeks)
- The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio(6 weeks (baseline) and 12 weeks)
- The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.(6 weeks (baseline) and 12 weeks)
研究者
研究点 (2)
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