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Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00115375
First received: June 21, 2005
Last updated: March 24, 2009
Last verified: March 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Congenital Heart Defects
Blood Platelet Disorders
 Drug: Clopidogrel (SR25990)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories (Neonates and Infants/Toddlers)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

Secondary Outcome Measures:
  • Adverse events

Enrollment: 92
Study Start Date: January 2004
Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neonates or infants/toddlers (up to 24 months) at risk for thrombosis (e.g., Blalock-Taussig shunt or any systemic to pulmonary artery shunt, Kawasaki disease, vascular stent or any condition requiring antiplatelet therapy).

Exclusion Criteria:

  • Ongoing bleeding or increased risk of bleeding

    • Weight < 2 kg; gestational age < 35 weeks
    • Allergy to drugs
    • Current or planned anticoagulant treatment
    • Unable to receive drug enterically
    • Platelet transfusion < 7days
    • Thrombocytopenia
    • Hepatic or renal failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115375

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Director: ICD CSD Sanofi
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00115375     History of Changes
Other Study ID Numbers: PDY4422
Study First Received: June 21, 2005
Last Updated: March 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
THROMBOSIS
PLATELET AGGREGATION
Pediatrics

Additional relevant MeSH terms:
Blood Platelet Disorders
Heart Defects, Congenital
Hematologic Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013