Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115375
Status:
COMPLETED
Last Update Posted:
2009-03-25
First Post:
2005-06-21
Brief Title:
Platelet Aggregation Inhibition in Children on Clopidogrel PICOLO
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories Neonates and InfantsToddlers
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infantstoddlers to determine the dose providing inhibition of platelet aggregation similar to adults
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 aggregation at steady state
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None