Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age

Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Children Aged 1 Year to Less Than 2 Years in Conjunction With Study 1160.89

Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group

Inclusion criteria:

1. males or females 1 to less than 2 years of age
2. objective diagnosis of primary venous thromboembolism
3. completion of planned treatment course with low molecular weight heparin or oral anticoagulant for primary venous thromboembolism
4. written informed consent by parent (legal guardian) and patient assent (if applicable)

Exclusion criteria:

1. weight less than 9 kg
2. conditions associated with increased risk of bleeding
3. patients who have any condition that would not allow safe participation in study Note: Further exclusion criteria apply