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)
Sponsor: Bristol-Myers Squibb
A PHASE2 clinical study on Blood Platelet Disorders and Congenital Heart Defects, this trial is completed. The trial is conducted by Bristol-Myers Squibb and has accumulated 7 data snapshots since 2004. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.
Study Description(click to expand)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.
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.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2025 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
▶ Show 2 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE2
First recorded
Jan 2004
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Bristol-Myers Squibb
- Sanofi
For direct contact, visit the study record on ClinicalTrials.gov .