Open-label safety and tolerability of dabigatran etexilate mesilate given for 3 days at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years, and 1 year to less than 2 years. - n.a.
- Conditions
- Venous Thrombotic EventMedDRA version: 12.0Level: LLTClassification code 10066899Term: Venous thromboembolism
- Registration Number
- EUCTR2009-013618-29-FR
- Lead Sponsor
- Boehringer Ingelheim France
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18
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:
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) severe 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This study is exploratory in nature and will investigate safety and tolerability of an oral liquid formulation of dabigatran etexilate in pediatric patients 1 to < 12 years old treated for primary VTE. The study will also provide preliminary pharmacokinetic and pharmacodynamic data for this age group. ;Secondary Objective: none;Primary end point(s): 1) Incidence of all bleeding events,<br>2) Pharmacodynamic parameters: central and local measurement of TT<br>3) Incidence of all adverse events.<br>4) Pharmacokinetic parameters: plasma concentrations of total and free dabigatran, BIBR 1048 BS, BIBR 951BS, and BIBR 1087 SE,<br>
- Secondary Outcome Measures
Name Time Method