KCT0000937招募中未知
A 24-Week, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients with Hypercholesterolemia or Low HDL-C
MSD Korea0 个研究点目标入组 800 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •If female, cannot be of reproductive potential
- •Has been treated with an appropriate dose of statins with or without other lipid modifying therapy for at least 6 weeks
- •Coronary heart disease (CHD) or other atherosclerotic vascular disease with multiple risk factors (including diabetes, metabolic syndrome) and/or high LDL-C/low HDL-C, or needing to meet a specific LDL-C/HDL-C goal
排除标准
- •Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
- •Homozygous familial hypercholesterolemia
- •Severe chronic heart failure
- •Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months
- •Uncontrolled hypertension
- •Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
- •Active or chronic hepatobiliary, hepatic, or gall bladder disease
- •History of mental instability, drug/alcohol abuse within the past five years or major psychiatric illness inadequately controlled and unstable
- •History of ileal bypass, gastric bypass, or other significant condition associated with malabsorption
- •Human immunodeficiency virus (HIV) positive
- •History of malignancy =5 years
- •Donated blood products or has had phlebotomy of >300 mL within 8 weeks or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study
- •Currently taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A) (including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St John's wort) or has discontinued treatment <3 weeks prior
- •Consumes more than 2 alcoholic drinks per day
- •Currently participating or has participated in a study with an investigational compound or device within 3 months
- •Receiving treatment with systemic corticosteroids or taking systemic anabolic agents
研究者
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