Phase I/IIa Study of Pharmacokinetics and Safety of Atorvastatin in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Participants With SAE
研究概览
简要总结
Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart attack. Although investigators can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Inflammation and damage to the arterial wall is central to these coronary artery abnormalities. Statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. Therefore, the investigators propose to study the safety of the drug atorvastatin in children with coronary artery abnormalities from KD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Use of a statin, fibrate, or niacin within the 3 months prior to enrollment
- •Have any chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder
- •Screening creatine phosphokinase (CK) ≥ 3x upper limit of normal for age
- •Patient taking a CYP3A4 inhibitor (ie. cyclosporine or clarithromycin) in the last 7 days
- •Patient has a history of allergy to atorvastatin or its derivatives
研究组 & 干预措施
Atorvasatin
Atorvastatin dose titration to maximum tolerated dose
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Number of Participants With SAE
时间窗: At 6 weeks after initiation of study drug
Number of participants who experienced an SAE within the 6 week study period
次要结局
未报告次要终点
研究者
Jane C. Burns MD
Chief, Division of Allergy, Immunology, Rheumatology
University of California, San Diego
