NCT01301066已完成4 期
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects With Dyslipidemia, Followed by a 40-Week Safety Extension Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 252
- 主要终点
- Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks
研究概览
简要总结
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent.
- •Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age >40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception
- •Documented HIV infection.
排除标准
- •Homozygous familial hypercholesterolemia
- •Any conditions that may cause secondary dyslipidemia
- •History of coronary artery disease (CAD) or CAD equivalent
研究组 & 干预措施
Pitavastatin 4 mg QD
Experimental
干预措施: Pitavastatin (Drug)
Pravastatin 40 mg QD
Active Comparator
干预措施: Pravastatin (Drug)
结局指标
主要结局
Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks
时间窗: 12 weeks minus baseline
次要结局
未报告次要终点
研究者
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