A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination and to Evaluate Single Dose Pharmacokinetics of MK0524A in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Cutaneous Bleeding Time (BT)
研究概览
简要总结
This is a 3-period study. Periods 1 and 2 will evaluate the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 will be open-label and will evaluate single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Participant has primary hypercholesterolemia or mixed dyslipidemia (high cholesterol)
- •Participant is a non-smoker
排除标准
- •Participant has a history of chronic seizures
- •Participant has a history of cancer
- •Participant has a history of stomach or intestinal ulcers or any history of GI bleeding
- •Participant has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
研究组 & 干预措施
Period 3
干预措施: niacin (+) laropiprant (Drug)
结局指标
主要结局
Cutaneous Bleeding Time (BT)
时间窗: Day 8
Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days versus BT on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days. The model used included treatment, period and sequence as fixed effect variables and subjects as the random effect variable. Period 3 was not analyzed as bleeding time was not an objective for this part of the study.
次要结局
未报告次要终点