Expired Study
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Bridgewater, New Jersey 08807


Purpose:

PICOLO is a double blind placebo controlled phase II dose ranging, dose escalating study in patients of Blalock-Taussig age categories (neonates and infants/toddlers), to determine the dose providing inhibition of platelet aggregation similar to adults.


Study summary:

There will be 3 blinded dose groups of 12 patients each (9 active, 3 placebo), central randomization, stratified by age (< 1 month ;1 to 24 months). There will be a comparison of ADP-induced platelet aggregation at steady state.


Criteria:

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


NCT ID:

NCT00115375


Primary Contact:

Study Director
ICD CSD
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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