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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01773174

Enrollment

Registered

2013-01-23

Start date

2013-01-31

Completion date

2015-12-31

Last updated

2015-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Brief summary

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

Interventions

DRUGdabigatran etexilate

age & weight adjusted equivalent of adult dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 2 Years

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

Design outcomes

Primary

Measure	Time frame
Activated prothrombin time (aPTT)	one day
Plasma concentrations of BIBR 1048 BS (Base)	one day
Plasma concentrations of BIBR 951 BS	one day
Plasma concentrations of BIBR 1087 SE (Acid)	one day
Ecarin clotting time (ECT)	one day
Factor IIa inhibition	one day
Incidence of all bleeding events	30 days
Incidence of all adverse events	30 days
Plasma concentrations of total dabigatran	one day
Plasma concentrations of free dabigatran	one day

Secondary

Measure	Time frame
Patient assessment of taste will be summarized across all patients in the treated set	one day
Changes in laboratory and clinical parameters	30 days
Global assessment of tolerability will be summarized across all patients in the treated set	30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026