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

NCT01083732 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-12-28

Study results available
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Summary

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

Conditions

  • Venous Thromboembolism

Interventions

DRUG

dabigatran etexilate

Experimental dose chosen based on age and weight

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Canada
  • Italy
  • Lithuania
  • Russia
  • Switzerland
  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01083732 on ClinicalTrials.gov