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 (Canada) Ltd/Ltée0 个研究点目标入组 16 人开始时间: 2013年3月20日最近更新: 2016年8月29日

试验速览

暂无简介。

•1) Male or female children 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.
•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) Weight less than 9 kg
•2) Conditions associated with an increased risk of bleeding
•3) Renal dysfunction or requirement for dialysis
•4) Active infective endocarditis
•5) Hepatic disease
•6) pregnant females or females not using medically accepted contraceptive method
•7) Anemia or thrombocytopenia
•8) use of prohibited or restricted drug within previous week
•9) received investigational drug within past 30 days

发起方

Boehringer Ingelheim (Canada) Ltd/Ltée