Trials / Completed
CompletedNCT00115375
Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)
Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories (Neonates and Infants/Toddlers)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 24 Months
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Clopidogrel (SR25990) |
Timeline
- Start date
- 2004-01-01
- Completion
- 2006-04-01
- First posted
- 2005-06-22
- Last updated
- 2009-03-25
Locations
6 sites across 6 countries: United States, Belgium, Canada, France, Germany, Italy
Source: ClinicalTrials.gov record NCT00115375. Inclusion in this directory is not an endorsement.