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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 459
- 主要终点
- Percent Change from Baseline in HDL-C
研究概览
简要总结
This study will evaluate the effects of 2 different dose levels of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with hypercholesterolemia when added to an existing statin-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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If female, cannot be of reproductive potential
- •Have been treated with an optimal dose of statin 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
研究组 & 干预措施
Anacetrapib 100 mg
干预措施: Anacetrapib 100 mg (Drug)
Anacetrapib 100 mg
干预措施: Placebo for anacetrapib 25 mg (Drug)
Anacetrapib 25 mg
干预措施: Placebo for anacetrapib 100 mg (Drug)
Anacetrapib 25 mg
干预措施: Anacetrapib 25 mg (Drug)
Placebo
干预措施: Placebo for anacetrapib 100 mg (Drug)
Placebo
干预措施: Placebo for anacetrapib 25 mg (Drug)
结局指标
主要结局
Percent Change from Baseline in HDL-C
时间窗: Baseline and Week 24
Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)
时间窗: Baseline and Week 24
Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3xULN (Upper Limit of Normal)
时间窗: 24 Weeks
Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms
时间窗: 24 weeks
Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <LLN (Lower Limit of Normal)
时间窗: 24 weeks
Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause
时间窗: 24 weeks
Number of Participants with Significant Increase in Blood Pressure
时间窗: 24 weeks
次要结局
- Percent change from Baseline in non-HDL-C(Baseline and Week 24)
- Percent Change from Baseline in Apolipoprotein B (Apo-B)(Baseline and Week 24)
- Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)(Baseline and Week 24)
- Percent Change from Baseline in Lipoprotein(a) (lp[a])(Baseline and Week 24)
- Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C goal(Baseline and Week 24)