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临床试验/NCT01431105
NCT01431105已完成1 期

Phase I/IIa Study of Pharmacokinetics and Safety of Atorvastatin in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jane C. Burns MD

Chief, Division of Allergy, Immunology, Rheumatology

University of California, San Diego

研究点 (1)

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