A Phase IIb, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Study to Assess the Efficacy and Safety of MK0859 in Japanese Patients With Dyslipidemia
概览
- 阶段
- 2 期
- 干预措施
- anacetrapib
- 疾病 / 适应症
- Dyslipidemia
- 发起方
- Merck Sharp & Dohme LLC
- 入组人数
- 408
- 主要终点
- The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8
- 状态
- 已完成
- 最后更新
- 10年前
概览
简要总结
This study will investigate the effect of MK0859 when administered alone and when in combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in Japanese patients with dyslipidemia.
详细描述
This is the dose ranging study to evaluate efficacy and safety of MK-0859 in Japanese patients. Eligible patients were assigned to 1 of 10 treatment groups (including treatment groups with or without administrative atorvastatin) for an 8-week treatment period which was followed by a 8-week reversibility period. As an additional follow-up, the pregnancy information from women of childbearing potential who were treated with MK-0859 in this study will be collected retrospectively for a period of 4 years after the last dose of MK-0859.
研究者
入排标准
入选标准
- •Patient is male or female and between the ages of 20 and 75 years diagnosed with dyslipidemia
排除标准
- •Patients has Coronary Heart Disease (CHD) or CHD-equivalent disease (except diabetes)
- •Patients has uncontrolled diabetes
- •Patient is currently participating or has participated in a study with an investigational compound within the last 3 months
研究组 & 干预措施
1
MK0859 10 mg + placebo
干预措施: anacetrapib
2
MK0859 40 mg + placebo
干预措施: anacetrapib
3
MK0859 100 mg + placebo
干预措施: anacetrapib
4
MK0859 300 mg + placebo
干预措施: anacetrapib
5
MK0859 10 mg + atorvastatin 10mg
干预措施: anacetrapib
6
MK0859 40 mg + atorvastatin 10mg
干预措施: anacetrapib
7
MK0859 100 mg + atorvastatin 10mg
干预措施: anacetrapib
8
MK0859 300 mg + atorvastatin 10mg
干预措施: anacetrapib
结局指标
主要结局
The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8
时间窗: 8 weeks
次要结局
- The percent change from baseline in High Density Lipoprotein-Cholesterol and safety (hepatitis related AEs, myalgia, rhabdomyolysis, blood pressure, laboratory tests: ALT, AST, CK, Na, Cl, bicarbonate, and K), at week 8(8 weeks)