Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

Completed · Phase 2

Conditions studied: Congenital Heart Defects, Blood Platelet Disorders

In brief

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.

Key facts

Study ID

NCT00115375

Run by

Sanofi

People needed

92

Starts

2004-01-01

Expected to finish

2006-04-01

Last updated by the study team

2009-03-25

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Diegem, Belgium
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Milan, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.