DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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:

Pharmacokinetics

Atorvastatin 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017