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

NCT01773174 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-10-26

No results posted yet for this study

Summary

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

Conditions

  • Venous Thromboembolism

Interventions

DRUG

dabigatran etexilate

age \& weight adjusted equivalent of adult dose

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01773174 on ClinicalTrials.gov