NCT00847197已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Lipid-Modifying Effect and Tolerability of MK1903 in Patients With Dyslipidemia
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
- 191
- 主要终点
- Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)
研究概览
简要总结
This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy.
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
- •Participant is not on a statin or other lipid-modifying therapy
- •Low or moderate risk participant
- •Male participants, and female participants not of reproductive potential
排除标准
- •Female participant of reproductive potential
- •Participant is pregnant, breastfeeding, or expecting to conceive during the study
- •Participant has history of cancer within 5 years of study (except certain types of skin and cervical cancer)
- •Participant is a user of recreational or illicit drugs or has a recent history of drug and/or alcohol abuse
- •Participant has donated or received blood within 8 weeks of study start or intends to give/receive blood during the study
- •Participant consumes more than 3 alcoholic drinks per day or more than 14 alcoholic drinks per week
- •Participant is currently experiencing menopausal hot flashes
- •Participant currently engages in vigorous exercise or an aggressive diet regimen
- •Participant is at high risk for heart conditions
- •Participant has Type 1 or Type 2 diabetes mellitus
- •Participant has poorly controlled cardiac arrhythmias
- •Participant has a history of stroke or other hemorrhage
- •Participant has poorly controlled high blood pressure
- •Participant has a thyroid condition or other endocrine/metabolic disease that would affect serum lipids
- •Participant has a disease of the kidney or liver
- •Participant has an ulcer within 3 months of screening
- •Participant is Human Immunodeficiency Virus (HIV) positive
- •Participant is taking cyclical hormonal contraceptives or non-continuous hormone replacement therapy
- •Participant is taking or has taken an Organic Anion Transporter (OAT1/3) inhibitor/substrate within 3 days of screening
- •Participant has taken an anti-obesity medication within 3 months of screening
- •Participant is taking coumarins
- •Participant is taking Non-steroidal Anti-inflammatory Drugs (NSAIDs) (acetaminophen and Cyclooxygenase-2 (COX-2) inhibitors are allowed)
- •Participant is taking more than 100 mg aspirin per day
- •Participant is being treated with oral, intravenous, or injected corticosteroids or anabolic agents
研究组 & 干预措施
1
Experimental
MK1903
干预措施: MK1903 (Drug)
结局指标
主要结局
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)
时间窗: Baseline and Week 4
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)
时间窗: Baseline and Week 4
次要结局
- Percent Change From Baseline in Triglycerides (mg/dL)(Baseline and 4 Weeks)
研究者
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