NCT00640549终止4 期
Impact of Atorvastatin on the Distribution, Composition, and Metabolism of LDL and HDL Subfractions: A Double-blind Placebo-controlled Phase IV Study With Patients Suffering From Combined Hyperlipidemia and Diabetes. Atorvastatin and LDL Profile in NIDDM (ALPIN Study)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2003年3月最近更新:
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
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)
研究概览
简要总结
The study will investigate the effects of atorvastatin on the concentrations of small, dense LDL and HDL subfractions in patients with diabetes and the underlying mechanisms of these effects.
详细描述
This study was terminated on October 6, 2004. The study terminated prematurely because of a higher screening failure rate than expected. There were no safety or efficacy reasons involved in the decision to terminate.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with a diagnosis of type 2 diabetes mellitus who either have never had a major adverse cardiac event (MACE) diagnosed before or who had a MACE diagnosed at least 6 months ago, but who, according to the judgement of the treating general practitioner, do not receive any hyperlipidemic therapy. Major adverse cardiac events (MACE) include myocardial infarction, coronary angioplasty, coronary artery bypass graft or other revascularization procedures.
- •At Screening:
- •Visit 1 (week -4):
- •Male patients aged >35 and ≤75 years and postmenopausal female patients ≤75 years with a diagnosis of type 2 diabetes mellitus
- •Patients have been euthyroid for at least six months
- •Written informed consent obtained
- •At Visit 2 (week 0):
- •LDL cholesterol ≥130 mg/dl (3.3 mmol/l ) and <190 mg/dl (4.9 mmol/l)
- •Triglycerides <150 mg/dl (1.69 mmol/l ) and <600 mg/dl (11.3 mmol/l)
- •Sum of LDL-5 and LDL-6 cholesterol ≥25 mg/dl (0.65 mmol/l)
- •Follicle stimulating Hormone (FSH) >30 U/l in female patients aged <60 years or FSH >20 U/l in female patients aged ≥60 years
排除标准
- •HbA1c > 8.0
- •Creatine kinase (CK) >5 times the upper limit of normal
- •Patients having taken lipid lowering medication within 8 weeks of the screening visit
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Drug)
1
Active Comparator
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)
时间窗: 8 weeks (visit 4)
Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1)
时间窗: 8 weeks (visit 4)
次要结局
- Changes in concentration of apolipoprotein B in VLDL, IDL, LDL-1 through LDL-6 and apolipoprotein A I in HDL subfractions 2a, 2b, and HDL-3 compared with screening (visit 1)(8 weeks (visit 4))
- Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1)(8 weeks (visit 4))
- Changes in size of LDL subfractions compared with screening (visit 1)(8 weeks (visit 4))
- Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1)(8 weeks (visit 4))
研究者
研究点 (1)
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