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Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00115375
First Posted: June 22, 2005
Last Update Posted: March 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: June 21, 2005
First Posted: June 22, 2005
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Sanofi:
THROMBOSIS
PLATELET AGGREGATION
Pediatrics

Additional relevant MeSH terms:
Heart Defects, Congenital
Blood Platelet Disorders
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Hematologic Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors