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

Boehringer Ingelheim

Status and phase: Withdrawn; Phase 2

Conditions: Venous Thromboembolism

Treatments: Drug: dabigatran etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01773174

1160.145

Details and patient eligibility

About

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

Sex: All

Ages: 1 to 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

dabigatran etexilate

Experimental group

Description:

single dose treatment with dabigatran oral solution

Treatment:

Drug: dabigatran etexilate