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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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19 February 2015 |
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Main ID: |
NCT00115375 |
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Date of registration:
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21/06/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)
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Scientific title:
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Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories (Neonates and Infants/Toddlers) |
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Date of first enrolment:
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January 2004 |
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Target sample size:
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92 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00115375 |
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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: Pharmacodynamics 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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Belgium
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Canada
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France
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Germany
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Italy
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United States
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Contacts
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Name:
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ICD CSD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Neonates or infants/toddlers (up to 24 months) at risk for thrombosis (e.g.,
Blalock-Taussig shunt or any systemic to pulmonary artery shunt, Kawasaki disease,
vascular stent or any condition requiring antiplatelet therapy).
Exclusion Criteria:
- Ongoing bleeding or increased risk of bleeding
- Weight < 2 kg; gestational age < 35 weeks
- Allergy to drugs
- Current or planned anticoagulant treatment
- Unable to receive drug enterically
- Platelet transfusion < 7days
- Thrombocytopenia
- Hepatic or renal failure
Age minimum:
N/A
Age maximum:
24 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Blood Platelet Disorders
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Congenital Heart Defects
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Intervention(s)
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Drug: Clopidogrel (SR25990)
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Primary Outcome(s)
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Percent inhibition of maximum extent and rate of aggregation of 5 µM ADP-induced platelet aggregation
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Secondary Outcome(s)
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Adverse events
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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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