Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dabigatran etexilate

single dose treatment with dabigatran oral solution

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

age \& weight adjusted equivalent of adult dose

Interventions

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dabigatran etexilate

age \& weight adjusted equivalent of adult dose

Intervention Type DRUG

Eligibility Criteria

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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)