NCT00510809已完成不适用
Safety and Efficacy of Policosanol Monotherapy and When Added to Chronic Statin Therapy: A Pilot Study
James Backes, PharmD1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Lipid Profile
研究概览
简要总结
To determine the effects of policosanol on the cholesterol profile.
详细描述
The primary objectives of this study are to determine the changes in the lipid profile [LDL-C, HDL-C, triglycerides, total cholesterol] and the emerging risk factor, Lp(a), when policosanol is added to statin therapy. Additionally, one more primary objective is to evaluate the safety of the combination regimen.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •LDL > 100
- •Male or Non-Pregnant Female. Women must be surgically sterile or postmenopausal and not using hormone replacement therapy (HRT) or using a stable, consistent HRT dose with intentions to continue therapy throughout the course of the study
- •Mentally competent to understand study rationale and protocol
- •Speak and read English
- •Currently receiving low to moderate dose statin therapy with plans to continue to the same dose for at least 8 weeks. Low to moderate dose statins include the following daily doses: atorvastatin ≤20 mg, fluvastatin ≤40 mg, lovastatin ≤40 mg, pravastatin ≤40 mg, rosuvastatin ≤10 mg, simvastatin ≤ 40 mg
排除标准
- •LDL < 100
- •Sensitivity to policosanol
- •Currently taking a high-dose statin or other lipid-lowering agents (i.e. high-dose niacin formulations [>500mg/day], bile-acid sequestrants, ezetimibe, fibrates and high-dose Omega-3 fish oils [>900mg of combined EPA/DHA daily])
- •Currently taking medications which have the potential to interact with policosanol (i.e. warfarin, high-dose aspirin)
- •Active liver disease or ALT level 2.5 times the upper limit of normal
- •Chronic disease involving hepatic, renal or coronary artery disease
- •Currently experiencing "flu-like" symptoms
- •Currently experiencing any form of acute physical injury
- •Acute psychiatric disorders
- •Immuno-compromised state
- •Currently taking systemic steroidal drugs
- •Currently pregnant or lactating
- •Females of childbearing potential
- •Dependence on alcohol or illicit drugs
- •Participation in any other clinical trial within the last 30 days
- •Displays s/s of acute systemic infection (oral temperature >100°F, WBC>12x10³/µL)
研究组 & 干预措施
1
Active Comparator
Policosanol 20mg daily
干预措施: Policosanol (Drug)
2
Placebo Comparator
干预措施: Placebo (Other)
3
Active Comparator
Policosanol 20mg daily Plus Statin Therapy Already In Use
干预措施: Policosanol Plus Already In Use Statin Therapy (Drug)
结局指标
主要结局
Lipid Profile
时间窗: Change between Week 8 and Baseline
次要结局
- Adverse Events Reported(Week 8)
研究者
James Backes, PharmD
Clinical Associate Professor
University of Kansas Medical Center
研究点 (1)
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