A multicenter, double-blind, placebo-controlled, pharmacokinetic, pharmacodynamic, safety and tolerability study in patients aged 12 to <18 years of age with a central venous catheter to support prediction of the age appropriate dose of ticagrelor with similar levels of inhibition of platelet aggregation to 90 mg bd in adults - NA

AstraZeneca AB0 个研究点目标入组 18 人开始时间: 2012年11月15日最近更新: 2013年1月21日

研究概览

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•Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable EU guidelines
•Patients aged 12 to <18 years with a central venous catheter (CVC) with intended use for at least 5 days at
•time of randomisation.
•All post-menarche females are required to have a negative pregnancy test. Male and female patients are to adhere to appropriate contraceptive measures (if appropriate to the age of the child).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 18
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Sign or suspicion of extra-vascular bleeding in connection with placement of the CVC (>24 hours need to have elapsed since any sign or suspicion of ongoing bleeding, in order to allow randomisation of the patient).
•Patients who have an ongoing bleeding, risk of bleeding, previous intracranial haemorrhage, or platelet count <100,000 x 109/L.
•Surgery within 7 days unless judged to be a low risk for bleeding and at least 24 hours after surgery.
•Patients who are taking aspirin or other non-steroidal anti-inflammatory drugs within a week before randomisation and during the study period.
•Patients who are taking ADP receptor blockers (eg, clopidogrel, prasugrel,ticlopidine), dipyridamole, and cilostazol within a week before randomisation and during the study period.

发起方