Single dose open-label PK/PD, safety and tolerability study of dabigatran etexilate mesilate given at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years followed by 1 year to less than 2 years.

Boehringer Ingelheim RCV GmbH & Co KG0 个研究点目标入组 16 人开始时间: 2011年11月28日最近更新: 2016年4月11日

试验速览

暂无简介。

•1) Males or females 1 to < 12 years of age
•2) Objective diagnosis of VTE
•3) End of planned treatment course with low molecular weight heparin (LMWH) or oral anticoagulant (OAC) for VTE with INR and aPTT both within normal limits.
•4) Written informed consent provided by the patient’s parent (or legal guardian) and assent provided by the patient (if applicable) at the time of ICF signature.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 16
•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

•1) conditions associated with increased risk of bleeding
•2) renal dysfunction or requirement for dialysis
•3) active infective endocarditis
•4) hepatic disease
•5) anemia or thrombocytopenia
•6) use of prohibited or restricted drug within previous week
•7) pregnant females or females not using medically accepted contraceptive method
•8) received investigational drug within past 30 days
•9) unreliable patients or patients who have any condition that would not allow safe participation in study
•10) Weight less than 9 kg

发起方