A Randomized, Double-blind Study of the Effect of RO4607381 in Combination With Pravastatin on HDL-cholesterol (HDL-C) Levels in Patients With Low or Average HDL-C Levels
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 292
- 主要终点
- Percent Change From Baseline in HDL-C Level\n
研究概览
简要总结
This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients 18-75 years of age;
- •dyslipidemic patients with low or relatively low HDL-C levels during treatment with pravastatin.
排除标准
- •women who are pregnant, breastfeeding, or of child-bearing potential;
- •morbid obesity;
- •uncontrolled hypertension;
- •poorly controlled or insulin-treated diabetes;
- •high creatinine levels or history of statin-associated myopathy.
研究组 & 干预措施
Placebo
干预措施: Pravastatin (Drug)
Dalcetrapib 300mg
干预措施: Pravastatin (Drug)
Dalcetrapib 300mg
干预措施: Dalcetrapib (Drug)
Dalcetrapib 600mg
干预措施: Pravastatin (Drug)
Dalcetrapib 600mg
干预措施: Dalcetrapib (Drug)
Dalcetrapib 900mg
干预措施: Pravastatin (Drug)
Dalcetrapib 900mg
干预措施: Dalcetrapib (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in HDL-C Level\n
时间窗: 12 Weeks
Absolute Change From Baseline in HDL-C Level\n
时间窗: Week 12
次要结局
- Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB(Baseline and at 12 Weeks)
- AEs, Lab Parameters, Vital Signs, ECG(Through 9 Months)
- Percent Change of Fasting Glucose Level(12 weeks)
- Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI(12 weeks)