Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities
Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kawasaki Disease
Intervention: Atorvastatin (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: University of California, San Diego Official(s) and/or principal investigator(s): Jane C Burns, MD, Principal Investigator, Affiliation: University of California, San Diego
Overall contact: Jane C Burns, MD, Phone: 858-246-0155, Email: jcburns@ucsd.edu
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 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.
Clinical Details
Official title: Phase I/IIa Study of Pharmacokinetics and Safety of Atorvastatin in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety of atorvastatin in children with coronary artery abnormalities secondary to Kawasaki disease
Secondary outcome: PharmacokineticsAtorvastatin Activity
Eligibility
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
1. Age ≥ 2 years to 17 years old
2. 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
3. Patient presents within the first 20 days after fever onset
4. Parent or legal guardian able and willing to provide informed consent and subject
willing and able to provide assent when appropriate.
5. Post-menarchal females: Negative pregnancy test at screening and willing to use two
forms of contraception during the study
6. Males engaging in sexual activity that could lead to pregnancy must use a condom.
Exclusion Criteria:
1. Use of a statin, fibrate, or niacin within the 3 months prior to enrollment
2. Have any chronic disease, except asthma, atopic dermatitis, autism or controlled
seizure disorder
3. Screening creatine phosphokinase (CK) ≥ 3x upper limit of normal for age
4. Patient taking a CYP3A4 inhibitor (ie. cyclosporine or clarithromycin) in the last 7
days
5. Patient has a history of allergy to atorvastatin or its derivatives
Locations and Contacts
Jane C Burns, MD, Phone: 858-246-0155, Email: jcburns@ucsd.edu
University of California San Diego, San Diego, California 92093, United States; Recruiting Adriana H. Tremoulet, MD, MAS, Phone: 858-246-0012, Email: atremoulet@ucsd.edu Jane C. Burns, MD, Phone: 858-246-0155, Email: jcburns@ucsd.edu Jane C Burns, MD, Principal Investigator Adriana H Tremoulet, MD, Sub-Investigator
Additional Information
Starting date: July 2012
Last updated: December 2, 2014
|