Clinical Trial: Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories (Neonates and Infants/Toddlers)

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 inhibition of platelet aggregation similar to adults.

Detailed 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.
Sponsor: Sanofi

Current Primary Outcome: Percent inhibition of maximum extent and rate of aggregation of 5 µM ADP-induced platelet aggregation

Original Primary Outcome:

Current Secondary Outcome: Adverse events

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: June 21, 2005
Date Started: January 2004
Date Completion:
Last Updated: March 24, 2009
Last Verified: March 2009