Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/IIa Study of Pharmacokinetics and Safety of Atorvastatin in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease|
- Safety of atorvastatin in children with coronary artery abnormalities secondary to Kawasaki disease [ Time Frame: At 6 weeks after initiation of study drug ] [ Designated as safety issue: Yes ]Evaluation of cholesterol, liver functions, and markers of myopathy at the above time points.
- Pharmacokinetics [ Time Frame: 0,1,2,6,12,24 hours at baseline; 2&6 weeks ] [ Designated as safety issue: No ]Blood will be drawn around the first dose at 0,1,2,6,12 and 24 hours and troughs will be drawn at 2 weeks and 6 weeks during the clinic visit.
- Atorvastatin Activity [ Time Frame: Baseline, 2 weeks and 6 weeks ] [ Designated as safety issue: No ]Measures of oxidative stress will be assessed at baseline, 2 weeks and 6 weeks after study enrollment.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Atorvastatin dose titration to maximum tolerated dose
Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)
Other Name: Lipitor
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431105
|Contact: Jane C Burns, MDfirstname.lastname@example.org|
|Contact: Adriana Tremoulet, MD, MASemail@example.com|
|United States, California|
|University of California San Diego||Recruiting|
|San Diego, California, United States, 92093|
|Contact: Adriana H. Tremoulet, MD, MAS 858-246-0012 firstname.lastname@example.org|
|Contact: Jane C. Burns, MD 858-246-0155 email@example.com|
|Principal Investigator: Jane C Burns, MD|
|Sub-Investigator: Adriana H Tremoulet, MD|
|Principal Investigator:||Jane C Burns, MD||University of California, San Diego|