Status:
COMPLETED
Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Children's Hospital Colorado
University of Colorado, Denver
Conditions:
Kawasaki Disease
Eligibility:
All Genders
2-17 years
Phase:
PHASE1
PHASE2
Brief Summary
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 d...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age ≥ 2 years to 17 years old
- Meets clinical criteria for KD according to American Heart Association guidelines (Table 2): Fever (T≥38oC or 100.4oC) ≥ 3 days and ≥ 2 clinical criteria with left anterior descending coronary artery/right coronary artery z-score ≥ 2.5 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary arteries
- Patient presents within the first 20 days after fever onset
- Parent or legal guardian able and willing to provide informed consent and subject willing and able to provide assent when appropriate.
- Post-menarchal females: Negative pregnancy test at screening and willing to use two forms of contraception during the study
- Males engaging in sexual activity that could lead to pregnancy must use a condom.
- Exclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01431105
Start Date
July 1 2012
End Date
July 1 2018
Last Update
May 6 2020
Active Locations (1)
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1
University of California San Diego
San Diego, California, United States, 92093