NCT00216463已完成2 期
A Phase 2, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Varying Loading and Maintenance Dosing Regimens of ISIS 301012 Administered to Hypercholesterolemic Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Percent reduction in LDL-cholesterol from baseline
研究概览
简要总结
The aim of this study is to assess the safety and tolerability of varying dose and load regimens of ISIS 301012 in people who have elevated LDL-cholesterol levels.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI >/= 25 to </= 32 kg/m^2
- •fasting stable LDL-cholesterol >/= 130 mg/dL (3.36 mmol/L) and triglycerides < 400 mg/dL (4.55 mmol/L)
- •Females not of childbearing potential
排除标准
- •No endocrine, hematologic, renal, hepatic, metabolic, psychiatric, neurology, pulmonary or cardiovascular disease
- •Subjects who test positive for hepatitis B, C or HIV
- •Current diagnosis or known history of liver disease, such as acute or chronic hepatitis, liver cirrhosis, liver steatosis, or liver function abnormalities such as AST, ALT, GGT, or total bilirubin >/= 1.5 x ULN at Screening
- •A systolic blood pressure >/= 160 mmHg or a diastolic blood pressure >/= 95 mmHg on 2 occasions during Screening
- •Concomitant medications within 14 days of dosing, except hormone replacement therapy for post-menopausal women and acetylsalicylic acid or paracetamol dosed for fewer than five consecutive days
- •Subject has taken any lipid-lowering drug within 30 days or five half-lives (of the lipid-lowering drug) whichever is longer, prior to Screening
- •Alcohol or drug abuse within 2 years of Screening
- •Donated blood (450 mL) within the 3 months prior to Screening or suffered significant blood loss equal to a blood donor portion
- •Subject smokes > 10 cigarettes, or more than one pipe or one cigar per day
研究组 & 干预措施
A
Experimental
Slow load with every other week maintenance
干预措施: ISIS 301012 or Placebo (Drug)
B
Experimental
Slow load with every other week maintenance
干预措施: ISIS 301012 or Placebo (Drug)
C
Experimental
No load; once weekly maintenance
干预措施: ISIS 301012 or Placebo (Drug)
D
Experimental
No load; once weekly maintenance
干预措施: ISIS 301012 or Placebo (Drug)
E
Experimental
No load; once weekly maintenance
干预措施: ISIS 301012 or Placebo (Drug)
结局指标
主要结局
Percent reduction in LDL-cholesterol from baseline
时间窗: 14 days post dosing
次要结局
- Percent reduction in apoB-100 from baseline(14 days post dosing)
- Percent change from baseline in HDL-cholesterol, triglycerides, total cholesterol, non-HDL cholesterol, VLDL and LP(a)(14 days post dosing)
- Percent change from baseline in LDL/HDL and apoB-100/apo-A1 ratios(14 days post dosing)
研究者
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