Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Venous Thromboembolism

Treatments: Drug: dabigatran etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01083732

2009-013618-29 (EudraCT Number)

1160.89

Details and patient eligibility

About

To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data

Full description

Purpose:

Enrollment: 18 patients

Sex: All

Ages: 1 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. males or females 1 to less than 12 years of age
2. objective diagnosis of primary VTE
3. completion of planned treatment course with LMWH or OAC for primary VTE
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

Trial design

18 participants in 1 patient group

dabigatran etexilate

Experimental group

Description:

treatment with dabigatran oral solution as a single dose

Treatment:

Drug: dabigatran etexilate