NCT00335699已完成4 期
A 6-Week, Randomised, Open-Label, Parallel Group, Multi-Centre Study to Compare the Efficacy of Rosuvastatin 10mg With Atorvastatin 10mg in the Treatment of Non-Diabetic Metabolic Syndrome Subjects With Raised LDL-C
适应症
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
- 370
- 试验地点
- 8
- 主要终点
- The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg in the percentage reduction of LDL-C in Subjects with metabolic syndrome after 6 weeks of treatment.
研究概览
简要总结
The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg in the percentage reduction of LDL-C in Subjects with metabolic syndrome after 6 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
- 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
- •Metabolic syndrome patient; Presence of 3 or more of the following:
- •Abdominal obesity (waist circumference): men > 90cm(36 inch), women > 80cm(32 inch)
- •Triglycerides ≥ 150 mg/dL (1.70 mmol/L)
- •HDL-C: men < 40 mg/dL (1.04 mmol/L), women < 50 mg/dL (1.3 mmol/L)
- •BP ≥130/≥85 mmHg or subject receiving anti-hypertensive treatment
- •Fasting blood glucose 110 mg dL (6.11 mmol/L) - 125 mg/dL (6.94 mmol.L)
- •Elevated LDL-C concentrations reported within 4 weeks of visit 1 as follows;
- •≥ 130 mg/dL (3.36 mmol/L) to < 220 mg/dL (5.69 mmol/L) in statin naive subjects (subjects who have not taken any lipid-lowering therapy known to affect LDL-C in the 4 weeks prior to visit 1)
- •≥ 100 mg/dL (2.59 mmol/L) to < 160 mg/dL (4.14 mmol/L) in subjects who have taken a lipid lowering drug(s) within 4 weeks of visit 1
- •Triglyceride levels < 400 mg/dL (4.52 mmol/L)
- •Women of childbearing potential should be using a medically acceptable form of chemical or mechanical contraception.
排除标准
- •History of known diabetes mellitus
- •Use of anti-hyperglycaemic medication.
- •History of serious or hypersensitivity reactions to HMG-CoA reductase inhibitors, in particular history of myopathy.
- •No CHD or CHD Risk Equivalents and 0-1 Risk factors and Framingham 10-Year risk is <10%.
- •History of heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia).
- •Active arterial disease such as unstable angina pectoris, myocardial infarction, transient ischaemic attack (TIA), cerebrovascular accident (CVA), coronary artery bypass surgery (CABG) or angioplasty within 2 months prior to entry in the dietary lead in period
- •Uncontrolled hypothyroidism defined as thyroid stimulating hormone (TSH) > 1.5 times the upper limit of normal (ULN) at Visit 2 or subjects whose thyroid replacement therapy was initiated within 3 months of entry into dietary lead-in phase.
- •Current active liver disease (alanine aminotransferase [ALT] > 2 x ULN) or severe hepatic impairment.
- •Unexplained serum CK >3 times ULN (e.g. not due to recent trauma, intramuscular injections, heavy exercise, etc).
- •Serum creatinine > 176 umol/L (2.0 mg/dL)
- •History of alcohol, or drug, abuse or both.
结局指标
主要结局
The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg in the percentage reduction of LDL-C in Subjects with metabolic syndrome after 6 weeks of treatment.
次要结局
- Glucose and insulin resistance
- Safety
- The secondary objectives of this study are to compare the effects of rosuvastatin 10mg with atorvastatin 10mg in subjects with metabolic syndrome, after 6weeks of treatment, on:
- Bringing subjects to their established NCEP ATP III target goals for LDL-C
- Bringing subjects to their non-HDL target goal(based on NCEP-ATP III criteria)
- Modifying other lipids and lipid ratios
- Modifying inflammatory markers
研究者
研究点 (8)
Loading locations...
相似试验
已完成
4 期
ROMEO (Rosuvastatin in Metabolic syndrOme)Metabolic Syndrome XNCT00395486AstraZeneca258
已完成
3 期
Direct Statin Comparison of LDL-C Values: an Evaluation of Rosuvastatin TherapyHypercholesteremiaNCT00239330AstraZeneca824
已完成
3 期
COMETS - Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome SubjectsMetabolic SyndromeNCT00654485AstraZeneca940
已完成
3 期
Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects(ARIES)DyslipidaemiaHypercholesterolemiaNCT00653744AstraZeneca1,700
已完成
3 期
Treatment of Hypercholesterolaemia in Hispanic Subjects (STARSHIP)DyslipidaemiaHypercholesterolemiaNCT00653965AstraZeneca3,000