Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories (Neonates and Infants/Toddlers)

Sanofi7 个研究点分布在 6 个国家目标入组 92 人开始时间: 2004年1月1日最近更新: 2009年3月25日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Sanofi
入组人数: 92
试验地点: 7
主要终点: Percent inhibition of maximum extent and rate of aggregation of 5 µM ADP-induced platelet aggregation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: — 至 24 Months（Child）
性别: All
接受健康志愿者: 否

入选标准

•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).

排除标准

•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

结局指标

主要结局

Percent inhibition of maximum extent and rate of aggregation of 5 µM ADP-induced platelet aggregation

次要结局

Adverse events

研究者

发起方

Sanofi

申办方类型

Industry

研究点 (7)

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