Status:
COMPLETED
Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Congenital Heart Defects
Blood Platelet Disorders
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00115375
Start Date
January 1 2004
End Date
April 1 2006
Last Update
March 25 2009
Active Locations (6)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Diegem, Belgium
3
Sanofi-Aventis Administrative Office
Laval, Canada
4
Sanofi-Aventis Administrative Office
Paris, France