Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

Status Completed

Clinical Trial 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.

Clinical Trial 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 aggregation at steady state. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00115375
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 2
Start date	January 2004
Completion date	April 2006

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