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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 May 2016 |
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Main ID: |
NCT00305201 |
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Date of registration:
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20/03/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease
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Scientific title:
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Cardiovascular Risk Markers Before and After Therapy With Statins in Patients With History of Kawasaki Disease |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT00305201 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Chile
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Contacts
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Name:
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Arturo Borzutzky, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pontificia Universidad Catolica de Chile, School of Medicine, Department of Pediatrics |
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Name:
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Miguel Gutierrez, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pontificia Universidad Catolica de Chile, School of Medicine, Department of Rheumatology and Clinical Immunology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- History of Kawasaki disease more than 12 months before enrollment
- Present age of 8 years or older
Exclusion Criteria:
- Diabetes mellitus
- Not controlled hypertension
- Treatment with drugs thay modify endothelial function such as angiotensin converting
enzyme inhibitors, angiotensin II receptor antagonists, and calcium channel blockers
- Smokers of more than 5 cigarettes per day
- Total cholesterol higher than 250 mg/dl
- Triglycerides higher than 300mg/dl
- Chronic treatment with statins
- Chronic renal insufficiency (creatinine > 1.5 mg/dl)
Age minimum:
8 Years
Age maximum:
25 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kawasaki Disease
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Intervention(s)
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Drug: pravastatin
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Primary Outcome(s)
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Percent of change in brachial artery dilatation after statin therapy
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Secondary Outcome(s)
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Decrease in LDL
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Decrease in triglycerides
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Increase in HDL
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Decrease in high sensitivity CRP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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